chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 2 weeks ago she tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation (at the age of 60 years). The patient medical history and concomitant medications were not reported. She was scheduled to receive her second dose tomorrow (15Apr2021). However, on an unspecified date in 2021 (2 weeks ago) she tested positive for Covid with las test SARS-COV-2 test, and on 10Apr2021 (last Saturday) was still positive with lab test SARS-COV-2 test. She no longer had symptoms and had finished her quarantine. The concern was if she can receive her second dose of vaccine tomorrow. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold-like symptoms started on 06Apr2021 and have worsened; cold-like symptoms started on 06Apr2021 and have worsened; This is a spontaneous report from a contactable female consumer(patient) via Medical Information Team and report from Pfizer sponsored program. A female patient of an unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. On 06Apr2021, the patient had cold-like symptoms and have worsened. The patient would like to add that during the pandemic, and she have practiced the suggested safety protocols and only go out in public when necessary. Outcome of the events cold-like symptoms  and have worsened was unknown.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Malaise, Nervousness
Clinical narrative: I am very nervous and hyper / I  am getting really nervous now; I am very nervous and hyper; Insomnia; Headache; I have chills and chills are really bad; Feeling unwell / Just don't feel good; This is a spontaneous report from a contactable consumer, the patient.  A 82-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 04Mar2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing (Blood pressure about 30 years ago). Concomitant medication included valsartan (DIOVAN) for blood pressure abnormal, start and stop date were not reported; amlodipine besilate (NORVAS) for an unspecified indication, start and stop date were not reported. The patient experienced very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good. The patient stated, "Well I have the first vaccine on the 4th of March and sometimes I have had quite outcome probably many-many side effects but the side effect I am concerned about is, the first week I had insomnia for one week I do take sleepy meds the sleep developer and then I am very nervous and I couldn't relax that just appeared after week so that's not too bad still get a headache. I have chills and chills are really bad, I kept two sweater on and I just still cold all the time and then I feeling unwell. Just don't feel good you know I am very nervous and hyper I took "Quinidine" (drug name not clarified using as a treatment) I am wondering I am due for second shot on Thursday, will the side effects intensify or will get better? Will it get worst or some people I talk to say that the second shot is better, clear all the side effects I really don't know I am just concerned. I am getting really nervous now. Should I take the second vaccine or not?" Outcome of the events, very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity
Clinical narrative: I am very nervous and hyper / I  am getting really nervous now; I am very nervous and hyper; Insomnia; Headache; I have chills and chills are really bad; Feeling unwell / Just don't feel good; This is a spontaneous report from a contactable consumer, the patient.  A 82-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 04Mar2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing (Blood pressure about 30 years ago). Concomitant medication included valsartan (DIOVAN) for blood pressure abnormal, start and stop date were not reported; amlodipine besilate (NORVAS) for an unspecified indication, start and stop date were not reported. The patient experienced very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good. The patient stated, "Well I have the first vaccine on the 4th of March and sometimes I have had quite outcome probably many-many side effects but the side effect I am concerned about is, the first week I had insomnia for one week I do take sleepy meds the sleep developer and then I am very nervous and I couldn't relax that just appeared after week so that's not too bad still get a headache. I have chills and chills are really bad, I kept two sweater on and I just still cold all the time and then I feeling unwell. Just don't feel good you know I am very nervous and hyper I took "Quinidine" (drug name not clarified using as a treatment) I am wondering I am due for second shot on Thursday, will the side effects intensify or will get better? Will it get worst or some people I talk to say that the second shot is better, clear all the side effects I really don't know I am just concerned. I am getting really nervous now. Should I take the second vaccine or not?" Outcome of the events, very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Diaphragmatic disorder, Eye pain
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; I have a gland swelled right underneath my chin under my jaw; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; my eyes hurt; my hips hurt; my joint hurts; My hands hurt; This is spontaneous report received from contactable female consumer (Patient) reported for herself. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration in left arm on 26Mar2021 as single dose for COVID-19 immunization. Historical vaccine included received 1st dose of covid-19 vaccine (Lot number: EN6201) on unspecified date. Patient experienced second shot hurt and it was bleeding, got a very stiff neck on his left side and Patient cannot look over my shoulder on my left side; It hurts to hold my head up, tongue was swollen and I end up biting and that is hurting, his teeth even hurt, I have a headache in temple area, his skin hurts when touched, I have weakness all over and it hurts to talk, I have a gland swelled right underneath my chin under my jaw, back hurts, nauseated, diaphragm also hurts, it feels like I did 100 pushups or something, eyes hurt, hips and join hurt, hands hurt on 26Mar2021. Treatment was not given to the events. The outcome of events is known.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Injection site haemorrhage, Injection site pain, Lymphadenopathy
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; I have a gland swelled right underneath my chin under my jaw; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; my eyes hurt; my hips hurt; my joint hurts; My hands hurt; This is spontaneous report received from contactable female consumer (Patient) reported for herself. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration in left arm on 26Mar2021 as single dose for COVID-19 immunization. Historical vaccine included received 1st dose of covid-19 vaccine (Lot number: EN6201) on unspecified date. Patient experienced second shot hurt and it was bleeding, got a very stiff neck on his left side and Patient cannot look over my shoulder on my left side; It hurts to hold my head up, tongue was swollen and I end up biting and that is hurting, his teeth even hurt, I have a headache in temple area, his skin hurts when touched, I have weakness all over and it hurts to talk, I have a gland swelled right underneath my chin under my jaw, back hurts, nauseated, diaphragm also hurts, it feels like I did 100 pushups or something, eyes hurt, hips and join hurt, hands hurt on 26Mar2021. Treatment was not given to the events. The outcome of events is known.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain in extremity, Pain of skin, Swollen tongue
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; I have a gland swelled right underneath my chin under my jaw; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; my eyes hurt; my hips hurt; my joint hurts; My hands hurt; This is spontaneous report received from contactable female consumer (Patient) reported for herself. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration in left arm on 26Mar2021 as single dose for COVID-19 immunization. Historical vaccine included received 1st dose of covid-19 vaccine (Lot number: EN6201) on unspecified date. Patient experienced second shot hurt and it was bleeding, got a very stiff neck on his left side and Patient cannot look over my shoulder on my left side; It hurts to hold my head up, tongue was swollen and I end up biting and that is hurting, his teeth even hurt, I have a headache in temple area, his skin hurts when touched, I have weakness all over and it hurts to talk, I have a gland swelled right underneath my chin under my jaw, back hurts, nauseated, diaphragm also hurts, it feels like I did 100 pushups or something, eyes hurt, hips and join hurt, hands hurt on 26Mar2021. Treatment was not given to the events. The outcome of events is known.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; I have a gland swelled right underneath my chin under my jaw; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; my eyes hurt; my hips hurt; my joint hurts; My hands hurt; This is spontaneous report received from contactable female consumer (Patient) reported for herself. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration in left arm on 26Mar2021 as single dose for COVID-19 immunization. Historical vaccine included received 1st dose of covid-19 vaccine (Lot number: EN6201) on unspecified date. Patient experienced second shot hurt and it was bleeding, got a very stiff neck on his left side and Patient cannot look over my shoulder on my left side; It hurts to hold my head up, tongue was swollen and I end up biting and that is hurting, his teeth even hurt, I have a headache in temple area, his skin hurts when touched, I have weakness all over and it hurts to talk, I have a gland swelled right underneath my chin under my jaw, back hurts, nauseated, diaphragm also hurts, it feels like I did 100 pushups or something, eyes hurt, hips and join hurt, hands hurt on 26Mar2021. Treatment was not given to the events. The outcome of events is known.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: ended up getting Covid; This is a spontaneous report via a Pfizer Sponsored Program COVAX US Support from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got 1st dose on 10Mar2021 and then on 20Mar2021 ended up getting Covid. Patient would like to know how long one should wait to take the 2nd dose of the covid vaccine if they have contracted covid. And wanted to confirm that 6 weeks is the maximum time allowed between doses in order to receive maximum efficacy. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Illness, Inflammation, Petechiae, Platelet count
Clinical narrative: platelets were tested and had dropped from 296 in Fe to 18 by 01Apr; sick; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; petichiae; badly bruising; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient (not pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Mar2021 09:45 at the age of 33-year-old (Lot Number: EM6203) as single dose for covid-19 immunisation. Medical history included ulcerative colitis (remission), beta thal minor, allergies to aspirin and humira; Idiopathic thrombocytopenic purpura (ITP), delivery on28Jan2021. The patient had ITP during pregnancy (delivered 28Jan2021) and had been well in the normal platelet range at/after delivery. Concomitant medications included vedolizumab (ENTYVIO) taken for colitis ulcerative; folic acid; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 30Jan2021. The patient previously received the dose 1 bnt162b2 (Lot number: em9809) for covid-19 immunisation on 08Feb2021 09:30 AM. When the patient had the second dose (01Mar2021), she had an inflammation response wherein all of new/old scars swelled up and looked fresh (including an old bee sting, csection scar, etc). The patient also started badly bruising and having petichiae on 01Mar2021. Her platelets were tested and had dropped from 296 in Feb2021 to 18 by 01Apr2021, it continued to drop. This was the lowest they have ever been. She've been very sick on and off since having the second dose (01Mar2021) and recently finished high dose steroid treatment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of events and included treatment with high dose dexamethasone and blood monitoring. The events outcome was not recovered. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Skin swelling
Clinical narrative: platelets were tested and had dropped from 296 in Fe to 18 by 01Apr; sick; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; petichiae; badly bruising; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient (not pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Mar2021 09:45 at the age of 33-year-old (Lot Number: EM6203) as single dose for covid-19 immunisation. Medical history included ulcerative colitis (remission), beta thal minor, allergies to aspirin and humira; Idiopathic thrombocytopenic purpura (ITP), delivery on28Jan2021. The patient had ITP during pregnancy (delivered 28Jan2021) and had been well in the normal platelet range at/after delivery. Concomitant medications included vedolizumab (ENTYVIO) taken for colitis ulcerative; folic acid; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 30Jan2021. The patient previously received the dose 1 bnt162b2 (Lot number: em9809) for covid-19 immunisation on 08Feb2021 09:30 AM. When the patient had the second dose (01Mar2021), she had an inflammation response wherein all of new/old scars swelled up and looked fresh (including an old bee sting, csection scar, etc). The patient also started badly bruising and having petichiae on 01Mar2021. Her platelets were tested and had dropped from 296 in Feb2021 to 18 by 01Apr2021, it continued to drop. This was the lowest they have ever been. She've been very sick on and off since having the second dose (01Mar2021) and recently finished high dose steroid treatment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of events and included treatment with high dose dexamethasone and blood monitoring. The events outcome was not recovered. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus
Clinical narrative: Itching; Aches and pains; Pins and needles; This is a spontaneous report from a contactable consumer (reporting for herself).  A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation  (85-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. Patient states he has a pacemaker and has a stent in his heart. Both have been there for over 10 years. The patient's concomitant medications include carvedilol (COREG) at 25 mg, twice a day taken for cardiac disorder (He has been taking this for years). It was reported that patient previously took first dose of bnt162b2 (Lot number: EM9809, Expiry date: 30Jun2021) 04Feb2021 11:00. It was reported that during that night he was getting aches and pains, he took Tylenol and was fine for a while week. The week after that, he started to get pins and needles all over his body, and itching. He states it did not want to go away. Sometimes it was better, sometimes it was worse. The doctor gave him antihistamines, but it did not go away. All the doctor's say they have never heard of it, no one knows what it was. He read some place that they have few cases like this. He was just trying to find out what he should do. He was itching all the time and got pins and needles. The antihistamine helps, but it comes back. It has been over a month now, almost 2 months. He asks what he should do. He had seen a cardiologist, urologist, and his regular doctor. In the beginning he had itchiness and pins and needles all the time, but now it was on and off. For example right now he did not have it but when he woke up this morning it was there. He tried different soaps and different shampoos, just in case that was it. He even took off some of the medications for a couple days to be sure it was one of them but no. He was almost 100% sure it was it, he never had this before. Started the night of the shot. It got a little better in the night. The next morning he took Tylenol and felt better and thought it was all over. It was then explained that it started again about a week or so later and now he has it all the time. Itchiness began a week or a week or a half. Then says it could have been 2 weeks later. The symptoms are on and off. For the aches and pains he took Tylenol and it went away. The doctor that prescribed Coreg said he never had anyone having trouble taking this medication with the vaccine. He never heard of that. That was the first thing he asked. Outcome of the event Aches and pains was recovered on 26Feb2021. Outcome of the other events was not recovered.     No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: stiffness in her arm; severe soreness in her arm; This is a spontaneous report from a contactable consumer (patient) part of Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 28Mar2021 and 4 days after experiencing stiffness in her arm and then a week later experiencing severe soreness in her arm, and wanted to report this scenario. Her 2nd dose (18Apr2021). The outcome of the events in unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Burning sensation, Cardiac stress test, Dizziness
Clinical narrative: Whole blood is rushing to my heart after that I had attack; All my feet and hands were numb; Dizzy; When I have the attack I think am going to die because the attack was so intense I cannot breath like doing run; My hands are burning and numb/ patient is burning; heart beat 115; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm on 13Jan2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was taking unspecified concomitant drugs. Patient experienced that a week or so after the vaccine, patient started having blood pressure going down and it went down to like 102/64 so that was a concern, went to a cardiologist not to family physician and he said that patient has high blood pressure so he said start taking half of the Blood pressure medicine. Patient would think whole blood is rushing to the heart after that patient had attack, all the feet and hands were numb and patient would feel dizzy so that was concern and patient went to cardiologist after a week or so, had a stress test, after test had an ultrasound they all came clear. Patient had unpleasant attack it's like all of sudden, whole blood is boiling then patient would feel my heart beat like patient have been doing have a  blood pressure instrument would go to 110, heart beat 115 and then heart come out of my mouth it was so bad and then blood pressure instead of going down its started going up, in morning its up after 4hours it go down to 106/100 but all the tests, stress test, ultrasound all came clear so then family physician he has also done blood test, my blood test came all clear and then he said he need MRI of Brain even that came clear patient don't know, there is no change in the life  it only after having the vaccine patient started having these effects and then my doctor said I am need to have anxiety test now after one month the duration and the intensity that before and I went to hospital 3 times and family physician 5 times.Patient have the attack, thinks patient going to die because the attack was so intense, patient cannot breath like doing run, patient misses patient's breath. So after having all this for a month he gave me medication Zenith, it didn't help, then he gave me something 'Hydrol', that's not working too (further clarification unknown). Tomorrow, patient will see neurologist, till now, hands are burning and numb, cannot feel my leg from knees to my foot. Patient feels like the air conditioner is at 74 because patient is burning. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Hypertension, Hypoaesthesia
Clinical narrative: Whole blood is rushing to my heart after that I had attack; All my feet and hands were numb; Dizzy; When I have the attack I think am going to die because the attack was so intense I cannot breath like doing run; My hands are burning and numb/ patient is burning; heart beat 115; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm on 13Jan2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was taking unspecified concomitant drugs. Patient experienced that a week or so after the vaccine, patient started having blood pressure going down and it went down to like 102/64 so that was a concern, went to a cardiologist not to family physician and he said that patient has high blood pressure so he said start taking half of the Blood pressure medicine. Patient would think whole blood is rushing to the heart after that patient had attack, all the feet and hands were numb and patient would feel dizzy so that was concern and patient went to cardiologist after a week or so, had a stress test, after test had an ultrasound they all came clear. Patient had unpleasant attack it's like all of sudden, whole blood is boiling then patient would feel my heart beat like patient have been doing have a  blood pressure instrument would go to 110, heart beat 115 and then heart come out of my mouth it was so bad and then blood pressure instead of going down its started going up, in morning its up after 4hours it go down to 106/100 but all the tests, stress test, ultrasound all came clear so then family physician he has also done blood test, my blood test came all clear and then he said he need MRI of Brain even that came clear patient don't know, there is no change in the life  it only after having the vaccine patient started having these effects and then my doctor said I am need to have anxiety test now after one month the duration and the intensity that before and I went to hospital 3 times and family physician 5 times.Patient have the attack, thinks patient going to die because the attack was so intense, patient cannot breath like doing run, patient misses patient's breath. So after having all this for a month he gave me medication Zenith, it didn't help, then he gave me something 'Hydrol', that's not working too (further clarification unknown). Tomorrow, patient will see neurologist, till now, hands are burning and numb, cannot feel my leg from knees to my foot. Patient feels like the air conditioner is at 74 because patient is burning. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Myocardial infarction, Ultrasound scan
Clinical narrative: Whole blood is rushing to my heart after that I had attack; All my feet and hands were numb; Dizzy; When I have the attack I think am going to die because the attack was so intense I cannot breath like doing run; My hands are burning and numb/ patient is burning; heart beat 115; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm on 13Jan2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was taking unspecified concomitant drugs. Patient experienced that a week or so after the vaccine, patient started having blood pressure going down and it went down to like 102/64 so that was a concern, went to a cardiologist not to family physician and he said that patient has high blood pressure so he said start taking half of the Blood pressure medicine. Patient would think whole blood is rushing to the heart after that patient had attack, all the feet and hands were numb and patient would feel dizzy so that was concern and patient went to cardiologist after a week or so, had a stress test, after test had an ultrasound they all came clear. Patient had unpleasant attack it's like all of sudden, whole blood is boiling then patient would feel my heart beat like patient have been doing have a  blood pressure instrument would go to 110, heart beat 115 and then heart come out of my mouth it was so bad and then blood pressure instead of going down its started going up, in morning its up after 4hours it go down to 106/100 but all the tests, stress test, ultrasound all came clear so then family physician he has also done blood test, my blood test came all clear and then he said he need MRI of Brain even that came clear patient don't know, there is no change in the life  it only after having the vaccine patient started having these effects and then my doctor said I am need to have anxiety test now after one month the duration and the intensity that before and I went to hospital 3 times and family physician 5 times.Patient have the attack, thinks patient going to die because the attack was so intense, patient cannot breath like doing run, patient misses patient's breath. So after having all this for a month he gave me medication Zenith, it didn't help, then he gave me something 'Hydrol', that's not working too (further clarification unknown). Tomorrow, patient will see neurologist, till now, hands are burning and numb, cannot feel my leg from knees to my foot. Patient feels like the air conditioner is at 74 because patient is burning. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Ultrasound scan
Clinical narrative: Lymph node, on my left side which is where I got the vaccine were swollen, only the ones on my left side like one under my arm and the other one is above my clavicle; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via unspecified route of administration as a single dose for COVID-19 immunization in right arm on an unspecified date. Concomitant medications included, Atomoxetine, the brand name for that is Strattera. (further clarification unknown if consumer was taking brand or generic, hence both captured in tab). patient take more medicine but think that was fine and did not really think they have interaction, the other one was just birth control (not clarified further). Medical history included Irritable bowel syndrome. It was reported that, I got a blood test the other day, last week on Friday, that was my lab test. I went to my doctor because of my swollen lymph nodes, so they sent me for an ultrasound and the ultrasound showed that the lymph node was swollen. So, they sent me some blood test to do and I did them on Friday and I got the result for that and every thing in the result was normal. It was reported that, I did not know if this has already been recorded or not. After about two or week and a half after I had my first Pfizer Covid vaccine, my lymph node, on my left side which was where I got the vaccine were swollen, only the ones on my left side like one under my arm and the other one was above my clavicle. Therapeutic measures were not taken and stated, no, I have not. It still had not changed, it had been two weeks and it did not come down. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Full blood count, Metabolic function test, Myalgia
Clinical narrative: severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; I had to go to ER to give me some kind of shot but pain still there in my leg/painful in the thighs; This is a spontaneous report from a contactable consumer.   A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: ER8732) as SINGLE DOSE (at the age of 59 years old) for covid-19 immunisation .  Medical history included arthritis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. The patient's concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET) for pain "I am taking pain killer for it but it's not working".  Historical vaccination included BNT162B2, dose 1, Lot number:  EN6206, on 03Mar2021 for COVID-19 immunization at the age of 59 years old. On unknown date, the patient had severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on. He had to go to emergency room (ER) to give him some kind of shot but pain was still there in his leg. It brought back pain in his shoulder and in back that he had in the past and he was weak. "The reason that I stop and it felt pain went away but the back and the leg pain was still there and it is very very bad." Consumer stated, "Yes but I was not sure it was the vaccine causing it I had arthritis and I thought it might have been arthritis is causing it. It was like 10 hours later when I started to experience the side effect." The patient underwent lab tests and procedures which included complete blood count (CBC) : unknown result on unknown date , Comprehensive metabolic panel: unknown result on unknown date.  Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; I had to go to ER to give me some kind of shot but pain still there in my leg/painful in the thighs; This is a spontaneous report from a contactable consumer.   A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: ER8732) as SINGLE DOSE (at the age of 59 years old) for covid-19 immunisation .  Medical history included arthritis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. The patient's concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET) for pain "I am taking pain killer for it but it's not working".  Historical vaccination included BNT162B2, dose 1, Lot number:  EN6206, on 03Mar2021 for COVID-19 immunization at the age of 59 years old. On unknown date, the patient had severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on. He had to go to emergency room (ER) to give him some kind of shot but pain was still there in his leg. It brought back pain in his shoulder and in back that he had in the past and he was weak. "The reason that I stop and it felt pain went away but the back and the leg pain was still there and it is very very bad." Consumer stated, "Yes but I was not sure it was the vaccine causing it I had arthritis and I thought it might have been arthritis is causing it. It was like 10 hours later when I started to experience the side effect." The patient underwent lab tests and procedures which included complete blood count (CBC) : unknown result on unknown date , Comprehensive metabolic panel: unknown result on unknown date.  Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had the first dose on 28Feb2021 but after 2 days she was tested Covid19 Positive.; This is a spontaneous report received from from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 28Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, she was tested covid19 positive after two days of vaccination. She was told to take the second dose after 3 months and that is more than 21 days. The clinical outcome of the event was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test and was positive in Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender's Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence.   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: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle spasms, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 19Jan2021 11:00 AM at single dosefor covid-19 immunization. The patient took second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Pas drug event included Known allergies: cinnamon. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norethisterone acetate (JUNEL) taken for an unspecified indication, start and stop date were not reported. The patient previously took cinnamon and experienced drug hypersensitivity. The patient experienced "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" (medically significant, life threatening) on 20Jan2021 09:00 with outcome of recovering, "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" in Jan2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID tested post vaccination Nasal Swab, PCR (sars-cov-2 test): negative on 03Feb2021, negative on 10Feb2021, negative on 17Feb2021, negative on 10Mar2021, negative on 17Mar2021, negative on 26Mar2021, negative on 05Apr2021, negative on 07Apr2021. Therapeutic measures were taken as a result of "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021". Facility type vaccine was Hospital. No other vaccine in four weeks. AE resulted in Life threatening illness (immediate risk of death from the event). Ae treatment included treatment for Pulmonary Embolism, medications. No COVID prior vaccination.   Information on Lot/Batch number has been requested.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Malaise, Tremor
Clinical narrative: did not feel good the next day; it was like she had Covid, weak and had some shakes two days after; it was like she had Covid, weak and had some shakes two days after; it was like she had Covid, weak and had some shakes two days after; This is a spontaneous report from a contactable consumer (patient). A 76-year-old Patient of an unspecified gender received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection) via an unspecified route of administration in arm left on 20Mar2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was stated that patient wanted to report  side effects from the Pfizer Covid vaccine. Stated that patient had Covid in December. Stated that that the vaccine did something to nervous system like shaking that patient took it and for over 2 hours had chills. Later clarified that these side effects were from the second one. Stated that the pharmacist told if patient had antibodies not to get the shot. Stated patient had it checked and had antibodies left. Stated that patient had asked doctor if patient should get the vaccine since it was past 90 days since patient had Covid and he stated yes. Stated that patient took the first one. Stated patient did not feel good the next day on 20Mar2021. Stated that it was like patient had Covid, weak and had some shakes two days after on 20Mar2021. Stated that with the second one that patient had blurred vision and woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down. Stated that in the afternoon that patient had another spell of this. Stated that patient just felt better today. Stated that patient had heard others that had Covid and then had reports of them getting sick. No further details provided. Declined to complete a report about the others. Stated that Pfizer should know that people should not take the vaccine if they have antibodies. Stated that hair started coming out before the vaccine. Clarified that patient had antibodies checked three weeks before patient had first shot. Stated that that one pharmacist stated not to have it until summer and then another stated to go ahead and take it. Stated that patient had back and hip trouble and cannot get up the stairs good before the vaccine. Stated that the vaccine is supposed to protect you but who knows. Stated that patient took both doses of the vaccine. Stated that the pharmacist told if patient had antibodies not to get the shot. Stated that that one pharmacist stated not to have the vaccine until summer and then another stated to go ahead and take it. Outcome of event Shaking was recovered  on 11Apr2021, while with other events was recovered on 21Mar2021.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.