chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: tiny red tender area on her arm after first vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Nurse (patient) reported for herself. This 83-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 24Feb2021 10:30 (Lot number: EL9269 or S, it is an E or S, unknown which one was correct) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included micro-bacteria AVIUM (she has had about 20 years, no additional details provided). Concomitant medication(s) included calcium (CALCIUM); calcium pantothenate, cyanocobalamin, folic acid, liver extract, nicotinamide, pyridoxine hydrochloride, riboflavin, saccharomyces cerevisiae, thiamine mononitrate (B COMPLEX), and multivitamin.  The patient experienced tiny red tender area on her arm after first vaccine on 24Feb2021 and went away after 24 hours. The outcome of event was recovered on 24Feb2021. Reporter seriousness for the event was Disabling. Causality assessment was reported as related.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event erythema 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Influenza
Clinical narrative: Had bowel and felt like a lousy Flu; Had bowel and felt like a lousy Flu; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 07Jun2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history included aortic valve replacement from an unspecified date in Mar2021 to an unspecified date in Mar2021. The patient's concomitant medications were not reported. It was reported that, when probed for the concern, the consumer stated that, she think she had a side effect that has been unreported so far of the Pfizer vaccine (unspecified vaccine). Stated that, the patient had her first Pfizer injection (first dose) on 07Jun2021 and had no reaction until 4 days, later on the patient three day had bowel and felt like a lousy Flu. The outcome of the events was unknown.  Information about Lot/Batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Feels like he has been hit by a freight train; Low grade fever; had chills, and he has been all over the place; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 06Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Caller stated that he got his first shot on 06Jul2021, and now he is exuding several symptoms. He feels like he has been hit by a freight train, and he has a low-grade fever. He tried calling urgent medical and they said they didn't know what to do. He is trying to figure out what he can do to stop feeling like total dog crap. The patient had chills, and he has been all over the place. He feels like he has Covid just from getting the shot. He wants to feel better. The patient wants someone to prescribe him something to get this out of his system. The patient doesn't think he is going to get the second shot because he feels like absolute dog crap, and he doesn't think he is getting the second shot. He asks how he can alleviate these symptoms that he is having from the vaccine. He will just call his doctor. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Chest discomfort, Chest pain
Clinical narrative: Heart attack; Serious Diaphoresis; Serious discomfort in chest; sort of dull chest pain; dull chest pain; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Tachycardia; Felt extremely weak; This is a spontaneous report from a contactable consumer (patient). A 73-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jun2021 as single dose for covid-19 immunisation. Medical history included aortic valve replacement in March. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Jun2021 as single dose for covid-19 immunisation and had no reaction until 4 days, later on three day had bowel and felt like a lousy flu. Patient had second injection (second dose) on 28Jun2021 and had no reaction, had nothing and then past Friday morning and patient did not know what the date it was about 3 o'clock, had some serious discomfort in chest, it was sort of a dull chest pain it wasn't really bad but it was there, but every time patient would take a deep breath, he/she would have pain that would radiate into neck and to left shoulder that alone did not scare patient too much although it got his/her attention. Patient woke up and saw it was about 3 o'clock in the morning and about 7-8 o'clock in morning, patient finally get out of bed and started having more chest discomfort and had sudden onset of tachycardia about 122 to 126 each minutes at the same time. Patient had a serious onset of diaphoresis now, patient was scared maybe he/she was having a heart attack, so patient decided to go to Emergency room which patient did and all laboratories, chemistry, scans, EKG, Blood work and Troponin all  levels were normal. Patient really felt extremely weak, diaphoretic and tachycardia. Patient didn't know any better and if he/she was sitting and if someone came into office and told patient that it was time to see what was going on with EKG was normal at the same time, physician stated that he can probably be hold patient for at least 24 hours because patient was 73 years old and had an aortic valve replacement (History) in March, so it really had a concern. Cardiologist came in and listen to the patient and said EKG looks good, pulse was ok and thought they all to do Echo just to make sure cardiac aortic valve was doing well and supposed to do well. Outcome of the events was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Hyperhidrosis, Myocardial infarction, Neck pain
Clinical narrative: Heart attack; Serious Diaphoresis; Serious discomfort in chest; sort of dull chest pain; dull chest pain; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Tachycardia; Felt extremely weak; This is a spontaneous report from a contactable consumer (patient). A 73-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jun2021 as single dose for covid-19 immunisation. Medical history included aortic valve replacement in March. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Jun2021 as single dose for covid-19 immunisation and had no reaction until 4 days, later on three day had bowel and felt like a lousy flu. Patient had second injection (second dose) on 28Jun2021 and had no reaction, had nothing and then past Friday morning and patient did not know what the date it was about 3 o'clock, had some serious discomfort in chest, it was sort of a dull chest pain it wasn't really bad but it was there, but every time patient would take a deep breath, he/she would have pain that would radiate into neck and to left shoulder that alone did not scare patient too much although it got his/her attention. Patient woke up and saw it was about 3 o'clock in the morning and about 7-8 o'clock in morning, patient finally get out of bed and started having more chest discomfort and had sudden onset of tachycardia about 122 to 126 each minutes at the same time. Patient had a serious onset of diaphoresis now, patient was scared maybe he/she was having a heart attack, so patient decided to go to Emergency room which patient did and all laboratories, chemistry, scans, EKG, Blood work and Troponin all  levels were normal. Patient really felt extremely weak, diaphoretic and tachycardia. Patient didn't know any better and if he/she was sitting and if someone came into office and told patient that it was time to see what was going on with EKG was normal at the same time, physician stated that he can probably be hold patient for at least 24 hours because patient was 73 years old and had an aortic valve replacement (History) in March, so it really had a concern. Cardiologist came in and listen to the patient and said EKG looks good, pulse was ok and thought they all to do Echo just to make sure cardiac aortic valve was doing well and supposed to do well. Outcome of the events was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Scan, Tachycardia, Troponin
Clinical narrative: Heart attack; Serious Diaphoresis; Serious discomfort in chest; sort of dull chest pain; dull chest pain; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Tachycardia; Felt extremely weak; This is a spontaneous report from a contactable consumer (patient). A 73-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jun2021 as single dose for covid-19 immunisation. Medical history included aortic valve replacement in March. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Jun2021 as single dose for covid-19 immunisation and had no reaction until 4 days, later on three day had bowel and felt like a lousy flu. Patient had second injection (second dose) on 28Jun2021 and had no reaction, had nothing and then past Friday morning and patient did not know what the date it was about 3 o'clock, had some serious discomfort in chest, it was sort of a dull chest pain it wasn't really bad but it was there, but every time patient would take a deep breath, he/she would have pain that would radiate into neck and to left shoulder that alone did not scare patient too much although it got his/her attention. Patient woke up and saw it was about 3 o'clock in the morning and about 7-8 o'clock in morning, patient finally get out of bed and started having more chest discomfort and had sudden onset of tachycardia about 122 to 126 each minutes at the same time. Patient had a serious onset of diaphoresis now, patient was scared maybe he/she was having a heart attack, so patient decided to go to Emergency room which patient did and all laboratories, chemistry, scans, EKG, Blood work and Troponin all  levels were normal. Patient really felt extremely weak, diaphoretic and tachycardia. Patient didn't know any better and if he/she was sitting and if someone came into office and told patient that it was time to see what was going on with EKG was normal at the same time, physician stated that he can probably be hold patient for at least 24 hours because patient was 73 years old and had an aortic valve replacement (History) in March, so it really had a concern. Cardiologist came in and listen to the patient and said EKG looks good, pulse was ok and thought they all to do Echo just to make sure cardiac aortic valve was doing well and supposed to do well. Outcome of the events was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Both hands were pink; This is a spontaneous report from a contactable consumer (patient, reported for self). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date (on Thursday, it was about 12:00pm), as single dose for COVID-19 immunization. Medical history included redness. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date: UNKNOWN) administered in arm right on an unspecified date (on Thursday), as single dose for COVID -19 immunization (because she doesn't want to get sick) and stated both her hands and palms were very red color, like beet root, she had problems with her brain and experienced discoloration of her arm. Reporter stated the first time when they gave her the shot, both of her hands went red and it just spread through her blood and both of them became red. Reason for no lot number: Reporter stated she lost the application with that on it. On an unknown date, after second dose of vaccine the reporter stated her both hands were pink, just a little bit. Reporter stated she still has a little bit of redness, but its fine, she actually has it from school or kindergarten, the redness. She confirmed that she has recovered. Reporter stated no its not from the vaccination, the blood vessels, its a norm from her, it's from school. Outcome of the events was recovered.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Gastrointestinal hypomotility
Clinical narrative: Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; I could not go to the restroom very well; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration, on 29Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, the first thing that happened after 29Apr2021, on an unknown date in 2021, she started losing her appetite and then it had continuously got worse and one thing was that she could not eat as she did not have appetite and she could not go to the restroom very well. So, her doctor/primary care physician put her on some laxative (Trulance) (corrective for I could not go to the restroom very well), it was a very expensive laxative but he had some samples, some physician samples, professional sample not for sale, they were called Trulance, gave her a blister pack of seven and she took those over a month ago and they worked for a while but they are not working, no more. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Constipation, Decreased appetite, Ill-defined disorder, Illness
Clinical narrative: I am deathly ill; My feet are swollen up and bloated; Gut is bloated; I think I am dying; I am in a lot of pain; I could not go to the restroom very well; Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0773, Expiry date: unknown), via an unspecified route of administration on an unknown date in 2021 as dose 2, single for covid-19 immunisation.The patient medical history was not reported. Concomitant medications included plecanatide (TRULANCE) taken for an unspecified indication, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (Batch/Lot number: EW0171) on 29Apr2021 for covid-19 immunization and experienced losing her appetite and then it has continuously got worse. Well for one thing is that she could not eat, she didn't have appetite and she could not go to the restroom very well.  On an unknown date, the patient was deathly ill. The patient started losing her appetite and then it has continuously got worse. Well for one thing is that she could not eat, she didn't have appetite and she could not go to the restroom very well. So, her doctor, primary care physician put her on some laxative (Trulance) and gave her a blister pack of seven, she took those over a month ago and they worked for a while but they are not working, no more. The doctors want to put her in the hospital because her feet are swollen up and bloated, her gut is bloated and she think she was dying and but she don't want to go to the hospital because she is a single woman, she live by herself and she don't have any brothers or sisters, she is only child which means she don't have any nieces and nephews to help her out to keep an eye on her place and I have 4 cats. She have got another doctor's appointment on Friday and she am trying to find somebody that will 'drain her gut' on an outpatient basis, she have never been in a hospital.She was also in a lot of pain.The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: I am deathly ill; My feet are swollen up and bloated; Gut is bloated; I think I am dying; I am in a lot of pain; I could not go to the restroom very well; Started losing my appetite and then it has continuously got worse; I could not eat, I didn't have appetite; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0773, Expiry date: unknown), via an unspecified route of administration on an unknown date in 2021 as dose 2, single for covid-19 immunisation.The patient medical history was not reported. Concomitant medications included plecanatide (TRULANCE) taken for an unspecified indication, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (Batch/Lot number: EW0171) on 29Apr2021 for covid-19 immunization and experienced losing her appetite and then it has continuously got worse. Well for one thing is that she could not eat, she didn't have appetite and she could not go to the restroom very well.  On an unknown date, the patient was deathly ill. The patient started losing her appetite and then it has continuously got worse. Well for one thing is that she could not eat, she didn't have appetite and she could not go to the restroom very well. So, her doctor, primary care physician put her on some laxative (Trulance) and gave her a blister pack of seven, she took those over a month ago and they worked for a while but they are not working, no more. The doctors want to put her in the hospital because her feet are swollen up and bloated, her gut is bloated and she think she was dying and but she don't want to go to the hospital because she is a single woman, she live by herself and she don't have any brothers or sisters, she is only child which means she don't have any nieces and nephews to help her out to keep an eye on her place and I have 4 cats. She have got another doctor's appointment on Friday and she am trying to find somebody that will 'drain her gut' on an outpatient basis, she have never been in a hospital.She was also in a lot of pain.The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Contactable Consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in late Feb2021 as DOSE 1, SINGLE and in early Mar2021 as DOSE 2, SINGLE, both via an unspecified route of administration (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient just tested positive for covid last week in Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive last week (Jul2021). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain
Clinical narrative: Chills; Body ache; Sick; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was solution for injection, Lot Number: not reported), via an unspecified route on 13Jul2021 09:00, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was solution for injection, Lot Number: not reported), via an unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Jul2021, patient experienced chills, body ache (and no fever) and sick. Therapeutic measures were taken as a result of body ache. Outcome of all the events were unknown.  Information about lot and batch number was requested.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: Swollen up in the chest; Rapid Heartbeat; Muscle sore; Stomach ache; Headache; This is a spontaneous report from a contactable consumer. A 61-year-old patient of unspecified gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, on 06Jul2021 in the morning, as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jul2021, the patient stated that took the shot 4 days ago and experienced swollen up in the chest, had a rapid Heartbeat and just muscle sore and got like stomach-ache and Headache. Second dose vaccination due date was reported as 27Jul2021. The patient asked is that would be alright. The outcome of the events was unknown.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen up in the chest; Rapid Heartbeat; Muscle sore; Stomach ache; Headache; This is a spontaneous report from a contactable consumer. A 61-year-old patient of unspecified gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, on 06Jul2021 in the morning, as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jul2021, the patient stated that took the shot 4 days ago and experienced swollen up in the chest, had a rapid Heartbeat and just muscle sore and got like stomach-ache and Headache. Second dose vaccination due date was reported as 27Jul2021. The patient asked is that would be alright. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. He was scheduled to receive his second Pfizer Covid 19 Vaccine this Friday. Per caller he started having a sore throat on Sunday. The patient experienced sore throat on an unspecified date of 2021. Caller asking if it's okay to take an antibiotic prior to his second Pfizer Covid 19 Vaccine if the doctor prescribes one. Caller advised to call back if needed once he was seen by the doctor if a medication was prescribed and he had questions. Transferring agent stated his concern is he had a sore throat, he was thinking of taking an antibiotic (Treatment medication not clarified) so he wanted to if it will effect vaccine since he will be having his second dose of the vaccine on Friday. On paraphrasing the concern: Consumer stated Yes, the antibiotic before that second shot. Confirmed the vaccine as Pfizer Covid-19 vaccine. On confirming the first shot of Pfizer Covid19 vaccine: Consumer stated yes I did. Patient got that back on 6/12. (Not clarified hence not captured in tab) Consumer stated, Patient was scheduled for second shot this Friday at 10 O' clock. I started getting a sore throat on Sunday but it is getting little progressively little worse may be a Wednesday before Friday I wanted to take an antibiotic for my sore throat but I just want to make sure that this not gonna also effect the second shot. Consumer was informed about Pfizer medical information department. The call was disconnected while transferring to medical information department. Further probing was not done hence limited information available over the call. The outcome of event was unknown.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Lingering headache, chills, nausea
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: 16 days after dose 1 I found a supraclavicular lymph node on the left side; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0176 y EW0177) via an unspecified route of administration in the left arm on 24May2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient been tested for COVID-19, since the vaccination. Patient had covid tested post vaccination. On 24May2021, lab test included nasal swab (PCR COVID test) and result was negative. On 09Jun2021, (16 days after dose 1), patient had supraclavicular lymph node on the left side, it was the size of a bean and it hurt to touch it. As reported by the day of the second dose it was half the size but two days later it grew to the size of a golf ball (a lump coming out, as if half of the ball was inside the body and the other half outside, and it hurt). It was quite tender, but after 24 hours it went down to the size of a peach seed and today 55 days after the first dose I still have the lump, although it is very small and painless, but I still feel it. Adverse event result in visit to doctor or other healthcare professional office/clinic. The outcome of event was resolved on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood creatinine increased, Chest pain
Clinical narrative: angina on june 25 followed by chest pain, on and off, for a month (ongoing).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Please see the attached forms that describe the adverse events/symptoms in detail.  Thank you!
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Muscle twitching, Muscular weakness, Tenderness
Clinical narrative: Reported progressive bilateral weakness and tenderness to bilateral upper and lower extremities, with associated LUE and LLE twitching beginning 3 days after receipt of vaccination. Also notes persistent dyspnea on exertion. Patient reports symptoms mildly improved with over the counter ibuprofen. Patient referred to neurology for further evaluation, appointment pending.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inflammation, Migraine, Nausea, Near death experience
Clinical narrative: She is suffering says, about to die. She is having terrible migraine everyday. She cant get out of bed.; A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness.; She is very nauseous.; A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness.; She is suffering says, about to die. She is having terrible migraine everyday. She cant get out of bed.; This is a spontaneous report from a contactable consumer (husband). A 27-years-old female patient received bnt162b2 (Pfizer product), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: ER8736) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Events were reported as: A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness; she was very nauseous; She was suffering says, about to die. She is having terrible migraine every day. She can't get out of bed; it's terrible what happening in Jun2021. They had been seeing the physician and trying to help her. The event outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Genital discomfort, Genital pain, Genital rash, Genital swelling, Pruritus genital
Clinical narrative: itching, irritation, a 'bump' or rash on his genital and some pain; itching, irritation, a 'bump' or rash on his genital and some pain; itching, irritation, a 'bump' or rash on his genital and some pain; itching, irritation, a 'bump' or rash on his genital and some pain; itching, irritation, a 'bump' or rash on his genital and some pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that:  A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 18Jan2021 as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. The patient stated that a few weeks after getting the second dose of the Pfizer COVID-19 Vaccine, he started to experience some, "itching, irritation, a 'bump' or rash on his genital and some pain" on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Vaccination site pain, X-ray dental
Clinical narrative: First dose: soreness at the injection site that was pretty minimal; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:50 (at the age of 55-years-old) (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included omeprazole (OMEPRAZOLE) taken for antacid therapy, start and stop date were not reported. The patient previously received first shingrix vaccine for immunization on 19Jun2020, second shingrix vaccine for immunization on 31Aug2020, Flu vaccine for immunization on 23Nov2020. After first dose the patient experienced soreness at the injection site that was pretty minimal on Mar2021. she states she felt fine after getting both doses of the vaccine. The patient underwent lab test of X-ray, dental 3d X-ray for nerve pain, CT scan on the face with no result. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021893746 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a spontaneous report from a non-contactable consumer. An adult male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced appendicitis on an unspecified date with outcome of unknown. The consumer reported her husband developed appendicitis 2 weeks following the Pfizer vaccine. It's listed as a major adverse event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tremor
Clinical narrative: Legs shaking extreme; first dose on 18Mar2021, second dose on 13May2021; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 17:00 (Batch/Lot Number: EW0177) at the age of 20-yers-old, as DOSE 2, SINGLE for covid-19 immunisation. No prior vaccinations. The patient medical history was not reported. Concomitant medication included fluvoxamine (FLUVOXAMINE) taken for an unspecified indication from 2006 and ongoing; lamotrigine (LAMICTAL) taken for an unspecified indication from 2009 and ongoing. Historical Vaccine included bnt162b2 (1st shot of covid vaccine, Anatomical location: Left arm, Lot number: EN6208, EN6206, Time: 12:00 PM) for covid-19 immunisation on 18Mar2021 at the age of 20 year old and experienced (Sinus) tachycardia, Heart inflammation, chest pain, left atrial enlargement, enlarged heart size. The patient previously used Rexulti from 2010 to 06Jan2021. The patient experienced legs shaking extreme on 16May2021. Seriousness criteria was provided as: Persistent/Significant disability/Incapacity, Important medical event, and Hospitalized for 2 days in 2021. AE required visit to: Physician office, Emergency room. The event outcome of legs shaking extreme was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching and a rash; Itching and a rash; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: FA6780, Expiry Date: unknown) via an unspecified route of administration on arm left on 04Jul2021 16:15 (age at vaccination: 49 years) as dose 1, single for COVID-19 immunization. Vaccination Facility Type was reported as  pharmacy. The patient medical history (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to Adverse events was reported as none. Patient concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none, first dose. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) If applicable, any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. No adverse events following prior vaccinations. On Jul2021, the patient experienced itching and a rash, since she took the shot and wondered if there is anything to take to stop the itching. Noticed this last week, she thinks it was on a Monday, she thought it was something she was eating, but it is still going on, so she knows it is not something she was eating. Time the Vaccination Was Given was reported as between 16:00 and 16:30. The Relevant Tests was reported as none. The clinical outcome of the events was not resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: been tired, with decreased energy; been tired, with decreased energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis. (Manu-facturer Control No:NUS2021US104132_NC). A 81-year-old age male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. No medical history reported. No concomitant medication reported. Patient reported that he had been tired, with decreased energy and stated that these symptoms began after he received the COVID-19 vaccine in April. The outcome of Events was unknown.  Information on Lot/Batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Musculoskeletal stiffness, Prostatic specific antigen
Clinical narrative: Severe legs muscular stiffness; This is a spontaneous report from a contactable consumer (patient). This 63-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN 6207) as dose 1, single for covid-19 immunisation.  Medical history included Inflamation carpal tunnel 2020 and ongoing (Physiotherapy). Concomitant medication(s) included diltiazem hydrochloride (ANGIOTROFIN) taken for high blood pressure from Jan2020 and ongoing; tamsulosin hydrochloride (SECOTEX OCAS) taken as prostrate treat from Feb2021 to Apr2021. The patient experienced severe legs muscular stiffness on 10Mar2021. Relevant tests: blood test on10May2021: glucose prostatic antigen units: 104, 7.75 (Norm low: 55, <4, Norm high: 99), Comments: before 8,66; blood test on 17Jun2021: glucose prostatic antigen units: 97 (Norm low: 55, Norm high: 99), Comments: After treatment on treatment. patient received treatment for the event. The outcome of event was not recovered. Event considered serious due to disability/incapacity.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Laboratory test, Pain
Clinical narrative: Body aches; Occasional chills; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for COVID-19 immunisation. On unspecified date, the patient experienced body aches and occasional chills. Reporter stated that on behalf of her mother who received her 2nd dose of the vaccine 1 month ago and since then she had body aches and occasional chills. Reporter questioned if this was normal and why the symptoms would linger on for so long. Patient had seen a doctor and reporter stated that they did blood work and a bunch of test and they had not found out why. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Rash on her butt and that it started on her thigh and spread.; hives; itching; bad reaction rash that swelled up like hives when itchy/swelling of the face; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash on her butt and spread to thigh, hives, itching, bad reaction rash that swelled up like hives when itchy/swelling of the face. Patient who was calling to report a rash with hives and itching after receiving the Pfizer Covid vaccine's 1st shot. Patient reported rash appeared 2 days after the vaccination and was still currently experiencing it. Patient wanted to know was this rash as a result of the vaccine. Informed patient to consult HCP for treatment recommendations. Patient stated that she had an appointment on the 28Jul2021 and had called to cancel to put it on the 30Jul2021. Stated that she had a different pharmacy that was going to take her. Stated that she had called to let someone know that she was going to have it at a different place. Stated that after 2-3 days that she started to have bad reaction rash that swelled up like hives when itchy. Wanted to know if this was a bad reaction from the first shot. Later stated that it was 3-4 days later. Later clarified that it was after the Pfizer Covid shot. Stated that she had that rash on her butt. Later stated that it started on her thigh and spread. The outcome of the event bad reaction rash that swelled up like hives when itchy/swelling of the face was unknown and not recovered for other events.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersomnia, Pruritus, Urticaria
Clinical narrative: Itchy hives but it was worse yesterday; He also slept for like 10-11 hours last; Hives; Itchy hives; This is a spontaneous report from a contactable consumer reported for a patient. A 13-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration for covid-19 immunization, past drug event was reported amoxicillin and experienced urticaria, azithromycin and experienced urticaria (had hives before after taking amoxicillin and azithromycin but they were smaller and stopped after a day or two, as reported). On 29Jun2021, the patient experienced hives, on an unspecified date of 2021 itchy hives, but it was worse yesterday on 12Jul2021, he also slept for like 10-11 hours last on Jul2021. Reportedly, a friend wrote [Son] has had terrible hives for 2 weeks. I feel so bad for him. We went to an allergist yesterday who put him on a ton of meds- it seems to be helping. I asked what is triggering the hives. She responded I can't tell you. Because she knows I'm obligated to report AEs. Then she wrote: Actually the allergist isn't sure. It's not food and she thinks environmental is unlikely. But we are waiting for bloodwork. So could be normal allergy. I feel terrible for him, he so uncomfortable. The increased meds yesterday seemed to help bc his whole body isn't red and hot. He still has itchy hives but it was worse yesterday. He also slept for like 10-11 hours last night, so he had enough relief to actually sleep. He has had hives before after taking amoxicillin and azithromyocin but they were smaller and stopped after a day or two. Therapeutic measures were taken as a result of hives, itchy hives. The outcome of the events hives, itchy hives was not recovered, the outcome of other events was unknown.  Information on lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, SARS-CoV-2 test, Skin exfoliation, Sunburn
Clinical narrative: when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; I didn't even burn my legs and they started peeling; when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 17May2021 17:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), methotrexate (METHOTREXATE), meloxicam (MELOXICAM), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), methylprednisolone (PRED [METHYLPREDNISOLONE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa, phenargan plus for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 patient reported when she was out in the sun for 45 minutes she burned extensively and after 3 weeks she is still red. She peeled but my skin was scaley, it isn't the usual sunburn she gets. She didn't her sister had same issue. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 09Jun2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021895011 same reporter, drug and event, different patient