chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Facial pain, Skin exfoliation
Clinical narrative: 2 days following her Pfizer shot, patients face started burning all over and became bright red.  Redness and pain continues but has lessened some to date (3/31/21).  Face started to peel a couple of days ago and is continuing to peel.  Patient describes it as a very intense sunburn, but she has not been out in the sun.  Patient is now on day 12 of reaction.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Became aware of individual when noted to meet the case definition for a Vaccine Breakthrough case. He is a resident of a facility who report he was brought to the hospital for respiratory complaints and tested Covid + at the hospital. Has a history of "underlying respiratory issues" per the facility.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Communication disorder, Deafness, Dehydration, Disturbance in attention
Clinical narrative: Loss of hearing to last less than 5 min.  followed by ringing ears through the following day.  Uncontrolled palsy for head and neck intermittently through the injection day.  I lost my voice and had spasms in my larynx.  For several hours I had a hard time choosing my words and speaking which was the scariest.  I could not focus enough to even wash my hands on injection day and had to be driven home from work.   I got dehydrated because water tasted horrible.  The next morning I am better on all fronts except the ringing in my ears wont stop
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Laryngospasm, Paralysis, Tinnitus
Clinical narrative: Loss of hearing to last less than 5 min.  followed by ringing ears through the following day.  Uncontrolled palsy for head and neck intermittently through the injection day.  I lost my voice and had spasms in my larynx.  For several hours I had a hard time choosing my words and speaking which was the scariest.  I could not focus enough to even wash my hands on injection day and had to be driven home from work.   I got dehydrated because water tasted horrible.  The next morning I am better on all fronts except the ringing in my ears wont stop
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Chest pain, Pulmonary embolism, Urinary tract infection
Clinical narrative: MODERNA COVID-19 Vaccine EUA  Patient received first dose of Moderna COVID vaccine on 1/20/2021, presented to Emergency Department on 1/29/2021 with complaints of left-sided chest pain below her breast, with an onset 1/26/2021. In ED diagnosed with Pulmonary Emboli in lower branches of left lung, and a urinary tract infection. Pulmonary Embolism diagnosed with CTA of Chest. Patient treated with Apixiban 10 mg BID with anticipated duration of therapy for at least 6 months.  Patient subsequently received second dose of Moderna COVID vaccine on 2/26/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: On Wednesday, March 31, 2021 patient received her first dose of Pfizer COVID vaccine (LOT # ER8737, EXP 7/2021) at approximately 11:52am. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness" at 12:10pm and vitals were taken by EMTs. Vitals at 12:12pm: BP: 160/86, HR: 74bpm, 02 sat: 99%. Lead PHN was alerted and upon assessment patient stated her blood pressure "normally runs on the higher side." Patient was walked over and seated on the anti-gravity chair with a bottle of water. Patient stated to Lead PHN & EMTs her last meal was at 11:45am. After 15 minutes patient stated her dizziness completed subsided and that she "felt better." Vitals were were offered at 12:24pm but were refused by patient. Patient was observed for an additional 30 minutes. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Patient was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Patient was also encouraged to sign-up on v-safe. Patient left vaccination site at approximately 1:00pm with a steady gait.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Nausea, Neck pain
Clinical narrative: Adding due to not being on side effect list: Horrible taste in month for first 12 hours,  Face numb 30 minutes after vaccine for 2 hours, Shoulder & neck pain, dizziness, nausea , sensation up back of neck from 30 minutes after for hour.   Did not see dr or have any treatment.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Adding due to not being on side effect list: Horrible taste in month for first 12 hours,  Face numb 30 minutes after vaccine for 2 hours, Shoulder & neck pain, dizziness, nausea , sensation up back of neck from 30 minutes after for hour.   Did not see dr or have any treatment.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Cellulitis, Erythema, Feeling hot, Lymphadenopathy
Clinical narrative: Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass.  The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Peripheral swelling
Clinical narrative: Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass.  The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Fatigue, Myalgia, Pharyngeal swelling
Clinical narrative: 30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking.  I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM.  I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM.  Dr.  gave me a prescription for an epi pen and prednisone, just in case symptoms worsened.  They did not, and I did not use either drug.  The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM.  By the time I woke up this morning (3/31), I don't think there is any lingering swelling.  I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience.  Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office.  I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction.  This report is focused on what appeared to be a mild anaphylactic reaction.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sensation of foreign body
Clinical narrative: 30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking.  I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM.  I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM.  Dr.  gave me a prescription for an epi pen and prednisone, just in case symptoms worsened.  They did not, and I did not use either drug.  The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM.  By the time I woke up this morning (3/31), I don't think there is any lingering swelling.  I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience.  Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office.  I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction.  This report is focused on what appeared to be a mild anaphylactic reaction.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Janssen -Covid 19-EUA  The patient was standing in observation and complained to me that she was dizzy. I sat her down and  Paramedic assessed the patient and recommended she be transported to the hospital.  The patient refused tranport and signed out AMA.  See Paramedic PCR for further details.  The patient stated she felt dizzy after her flu vaccine also.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: pt received COVID-19 vaccine Moderna on 3/3/21. pt reported deceased on 3/26/21 before he was able to receive 2nd dose scheduled on 3/31/21. pt reported COVID positive on 3/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Day 6 after the first injection my arm became itchy, the next day it is red, swollen, itchy, and kind of hard. Also hurts, like it did the day after I got it. After I got it, it only hurt for one day, so this is after the arm went back to feeling fine for a week.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache the next day on the 30th when he woke up. He did not take anything for it and it went away on its own after a couple hours.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient got light headed and laid down
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: My arm felt as if I could feel the vaccine moving down it, then began to tingle.  My vision went weird for a few minutes and I felt light headed and as if my whole body was vibrating/buzzing a bit.  It's hard to describe, but I knew something wasn't right.  I spoke with a nurse on site who suspected I had a vasovagal reaction to the vaccine.  I had to wait 40 minutes before I felt okay enough to leave the site.  I continued to feel off for the rest of the night, along with extreme fatigue and soreness in my arm, neck and back.  The day after the vaccine I still had extreme fatigue, muscle soreness, was nauseous, with hot flashes and chills throughout the day.  Currently on day 2 past the vaccine and still have fatigue and muscle soreness.  The other symptoms seem to have improved some.  I have not been able to sleep much that last 2 nights either.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: My arm felt as if I could feel the vaccine moving down it, then began to tingle.  My vision went weird for a few minutes and I felt light headed and as if my whole body was vibrating/buzzing a bit.  It's hard to describe, but I knew something wasn't right.  I spoke with a nurse on site who suspected I had a vasovagal reaction to the vaccine.  I had to wait 40 minutes before I felt okay enough to leave the site.  I continued to feel off for the rest of the night, along with extreme fatigue and soreness in my arm, neck and back.  The day after the vaccine I still had extreme fatigue, muscle soreness, was nauseous, with hot flashes and chills throughout the day.  Currently on day 2 past the vaccine and still have fatigue and muscle soreness.  The other symptoms seem to have improved some.  I have not been able to sleep much that last 2 nights either.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Sleep disorder, Visual impairment
Clinical narrative: My arm felt as if I could feel the vaccine moving down it, then began to tingle.  My vision went weird for a few minutes and I felt light headed and as if my whole body was vibrating/buzzing a bit.  It's hard to describe, but I knew something wasn't right.  I spoke with a nurse on site who suspected I had a vasovagal reaction to the vaccine.  I had to wait 40 minutes before I felt okay enough to leave the site.  I continued to feel off for the rest of the night, along with extreme fatigue and soreness in my arm, neck and back.  The day after the vaccine I still had extreme fatigue, muscle soreness, was nauseous, with hot flashes and chills throughout the day.  Currently on day 2 past the vaccine and still have fatigue and muscle soreness.  The other symptoms seem to have improved some.  I have not been able to sleep much that last 2 nights either.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: passed out; dizzy spell; fell down; have gotten shorter/ shrunk; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes, thyroid disorder, and bleeding. The patient stated "I am bleeder. My father had hemophilia and I have the female version which I never remember what it's called but I bleed easily but I didn't bleed at all for when I had the shot, it was fine." Concomitant medication included levothyroxine sodium (SYNTHROID). Patient stated, "Yes, I took my medication that morning. I take thyroid medication, blood pressure medication. I don't remember what I take for blood pressure." The patient reported "Well I am calling I felt just fine right now. I had my first shot by Pfizer on the 24th and I felt great and they watched me and I left and I was driving home and I had a dizzy spell while I was driving. I don't know if I passed out or not, I might have but if I did, it wasn't for very long, they were digging up the road I couldn't stop, couldn't park so I made it home okay and I was fine the rest of the day but then the next day, I had a lot of dizzy spells but I was at home so I didn't worry, I just sat down and I was okay and then the 3rd day I got up for breakfast and I bumped into everything, I dropped everything and then I started to get out of chair and the chair fell down and I fell down and that was just a mess. So, I went to bed and I felt at least if I fall, I fall on bed and that was the day I was dizzy but then it went away and I have been fine ever since. That began on 24th, the 24th was the first day and I did call my doctor and I have been trying to call here and I never think it through but finally today, sat to watch, hang on to the phone and what I am concerned about is getting my second vaccine. Is there anything I should watch for or tell anybody or, because my doctor said you shouldn't get dizzy but I did?" The patient confirmed the vaccine as Pfizer's Covid 19 vaccine. About the lot number, the patient stated, "It looks like EN, I am not sure if it's E and N 6203." The patient further reported, "No, I just went home and the first day I was over with it by the time I got home and I didn't had anymore. The next day I just sat down and rested, I knew it will go away and it did and then 3rd day I went to bed and just thought I would fall and hurt myself and that's everything I did. Well I used to be 5 foot 2 and a quarter but I think I have gotten shorter, I don't know what I really am but little bit shorter than that now and my weight is 100 and lets see, I am going to say 170, I don't think that's exactly right but it's pretty close to that I think, I didn't really weighed myself lately. 5 foot 2 and a quarter that's what I was when I did last but now I shrunk and less than that but I don't remember what I am." The outcome of the events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Bone pain, Chills
Clinical narrative: At about 11 pm on 3/26/21, patient experienced uncontrollable chills.  He did not sleep well.  On 3/27/21, he got a fever that ranged between 99.7 to 102.6.  He could not eat and thinking about it made his stomach upset.  Every bone and joint in his body ached, even his skin hurt and he had a bad headache.  Tylenol did little to alleviate any of these symptoms.  His fever  broke on 3/27/21 about 11 pm.  He still did not sleep well and slept until noon on 3/28/21.  His symptoms persisted except for the fever, though he still had chills that night.  He still did not feel well throughout 3/29/21 and 3/30/21 and he still ate very, very little until 3/31/21.  On 3/31/21, he was able to eat and went to the grocery, but it wiped him out and he slept for a couple of hours in the afternoon.  He still has a dull headache and very little energy that is keeping him from doing his daily activities.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Loss of personal independence in daily activities, Malaise, Pain of skin
Clinical narrative: At about 11 pm on 3/26/21, patient experienced uncontrollable chills.  He did not sleep well.  On 3/27/21, he got a fever that ranged between 99.7 to 102.6.  He could not eat and thinking about it made his stomach upset.  Every bone and joint in his body ached, even his skin hurt and he had a bad headache.  Tylenol did little to alleviate any of these symptoms.  His fever  broke on 3/27/21 about 11 pm.  He still did not sleep well and slept until noon on 3/28/21.  His symptoms persisted except for the fever, though he still had chills that night.  He still did not feel well throughout 3/29/21 and 3/30/21 and he still ate very, very little until 3/31/21.  On 3/31/21, he was able to eat and went to the grocery, but it wiped him out and he slept for a couple of hours in the afternoon.  He still has a dull headache and very little energy that is keeping him from doing his daily activities.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: At about 11 pm on 3/26/21, patient experienced uncontrollable chills.  He did not sleep well.  On 3/27/21, he got a fever that ranged between 99.7 to 102.6.  He could not eat and thinking about it made his stomach upset.  Every bone and joint in his body ached, even his skin hurt and he had a bad headache.  Tylenol did little to alleviate any of these symptoms.  His fever  broke on 3/27/21 about 11 pm.  He still did not sleep well and slept until noon on 3/28/21.  His symptoms persisted except for the fever, though he still had chills that night.  He still did not feel well throughout 3/29/21 and 3/30/21 and he still ate very, very little until 3/31/21.  On 3/31/21, he was able to eat and went to the grocery, but it wiped him out and he slept for a couple of hours in the afternoon.  He still has a dull headache and very little energy that is keeping him from doing his daily activities.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Fever, Chills, Weakness.  Taking Tylenol for fever reduction.  Lots of fluids.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature increased, Feeling cold, Headache, Neck pain
Clinical narrative: Around 12 PM start to feel a little chilly  and neck aches a bit (it was a little colder today so didn?t think too much of it and thought neck aches were from shrugging when a little chilly).  By 1:30-2 PM, was pretty chilly and wrapped up in sweatshirt and fleece jacket. By 3:30 PM used heating  pad and blanket but still cold.  From 4-6 PM  added another heating pad and 3 blankets totally covered from head to toe. Got up at 6 PM and took temperature and it was 102.1. (Don?t know if accurate since bundled up to much) neck aches more pronounced and giving me headache. Only lightly covered with blanket now so warming up finally  7:45 PM temp is 101.2. Whole body just achy now but especially low back.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Around 12 PM start to feel a little chilly  and neck aches a bit (it was a little colder today so didn?t think too much of it and thought neck aches were from shrugging when a little chilly).  By 1:30-2 PM, was pretty chilly and wrapped up in sweatshirt and fleece jacket. By 3:30 PM used heating  pad and blanket but still cold.  From 4-6 PM  added another heating pad and 3 blankets totally covered from head to toe. Got up at 6 PM and took temperature and it was 102.1. (Don?t know if accurate since bundled up to much) neck aches more pronounced and giving me headache. Only lightly covered with blanket now so warming up finally  7:45 PM temp is 101.2. Whole body just achy now but especially low back.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rash, Syncope, Vomiting
Clinical narrative: Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She notice a petechial rash along her neck and chin.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She notice a petechial rash along her neck and chin.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site swelling, Pruritus, Rash, Vomiting
Clinical narrative: Three hours after the vaccine, the patient experienced nausea, vomiting and had syncope at home. She notice a petechial rash along her neck and chin.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Pain, Pyrexia
Clinical narrative: Fever of over 102.3 for more that 24 hours Chills, body aches, pain, body swelling, injection site swelling (still over 48 hrs later), sweats. Very ill. On 3/31/2021 still have fever of 99.3
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Fever of over 102.3 for more that 24 hours Chills, body aches, pain, body swelling, injection site swelling (still over 48 hrs later), sweats. Very ill. On 3/31/2021 still have fever of 99.3
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: 6 hours after the injection the following side effects started: 1) headache 2) severe muscle aches 3) nausea 4) fever throughout the night spiking at 103.4  The following day Headache, muscle aches and fever continued.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Inappropriate schedule of product administration, Off label use
Clinical narrative: Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Developed mouth sores and didn't treat them.  I am just hoping they heal.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Crying, Decreased appetite, Delusion, Depression
Clinical narrative: Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving the vaccine (3/12/21) which have been ongoing since then. Starting 3 days ago began having paranoid delusions (3/28/21-today). Frequently crying with no life stressors. Severe insomnia (a few hours of sleep in the past 5 days). Cataract surgery on 3/30/21, started experiencing feelings of hopelessness. Symptoms have been accompanied by poor appetite, intermittent dizziness over the past 2 weeks. PCP believes they may be related to vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of despair, Full blood count normal, Insomnia, Metabolic function test
Clinical narrative: Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving the vaccine (3/12/21) which have been ongoing since then. Starting 3 days ago began having paranoid delusions (3/28/21-today). Frequently crying with no life stressors. Severe insomnia (a few hours of sleep in the past 5 days). Cataract surgery on 3/30/21, started experiencing feelings of hopelessness. Symptoms have been accompanied by poor appetite, intermittent dizziness over the past 2 weeks. PCP believes they may be related to vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: Sudden onset severe depressive episode (no history of depression) starting 2 days after receiving the vaccine (3/12/21) which have been ongoing since then. Starting 3 days ago began having paranoid delusions (3/28/21-today). Frequently crying with no life stressors. Severe insomnia (a few hours of sleep in the past 5 days). Cataract surgery on 3/30/21, started experiencing feelings of hopelessness. Symptoms have been accompanied by poor appetite, intermittent dizziness over the past 2 weeks. PCP believes they may be related to vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID19 on 03/22/2021
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sore, red, itchy area around injection site. Extends from top of shoulder to mid-bicep.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: I developed a large rash around the injection site.  It itches slightly and it is very warm to the touch, almost hot.  No pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Paraesthesia
Clinical narrative: Muscle aches, joint aches, prickly skin. Minor lightheadedness and slight headache. No fever. Events began around 9 am and have begun to subside now (about 7 pm). I did not feel the need for medical intervention, as I was made aware of the possibility of these events prior to receiving the vaccine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Headache
Clinical narrative: Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the following 2 days, March 28, 29, specifically after eating. March 30th, woke up with chills, sore throat, headache, body aches lasting all day. Diarrhea. No longer nauseated. March 31st, all symptoms subsiding except for a minor headache and sore throat with mild cough and phlegm.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Productive cough, Vomiting
Clinical narrative: Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the following 2 days, March 28, 29, specifically after eating. March 30th, woke up with chills, sore throat, headache, body aches lasting all day. Diarrhea. No longer nauseated. March 31st, all symptoms subsiding except for a minor headache and sore throat with mild cough and phlegm.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive to Covid-19 virus; she tested positive to Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 26Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received Pfizer Covid-19 vaccine first dose on 26Feb2021 and on 13Mar2021, she tested positive to Covid-19 virus and she's waiting for the local health department about tracing and never got the other test for covid-19 virus. She was supposed to return on 19Mar2021 and wanted to reschedule the appointment. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain at injection site immediately, swelling around site, after about an hour, cold chills and a headache, body aches about 2 hours after
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Rash
Clinical narrative: Rash on arm, soreness, chest soreness a week later that appeared.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching and slight swelling at injection site 7 days after injection.  Taking Benadryl and itch cream
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossitis, Periorbital cellulitis, Pharyngitis
Clinical narrative: glossitis  pharyngitis  periorbital cheilitis   attempted oral nystatin - without resolution of symptoms   attempted Diflucan - without resolution of symptoms   happened with both vaccines and lasted 2-3 weeks
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Covid arm 2 days after vaccine.  Raised warm sore itchy area at injection site about 3" diameter.   Started this morning.   Had same thing after 7 days with first shot.  Was told to report here if it happened again.  Will take Tylenol and Benedryl.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Encephalitis, Laboratory test, Lumbar puncture
Clinical narrative: Encephalitis Treated ED then hospitalized for three days. Steroid infusion.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Encephalitis Treated ED then hospitalized for three days. Steroid infusion.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye irritation, Fatigue, Headache
Clinical narrative: Large, hard knot in injection arm - c. 3" x 1.5" (full shoulder), very restricted movement - can not raise. Throbbing preventing sleep.  Ongoing, have used Advil and ice with no improvement. Chills & Fever - starting c. 26 hours after injection, continuing to increase (now 30 hours post vaccine) Headache - onset c. 18 hours post injection General - Tired / achy. Back pain. Burning eyes.   All ongoing and worsening.
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site joint movement impairment, Pain, Pyrexia, Sleep disorder
Clinical narrative: Large, hard knot in injection arm - c. 3" x 1.5" (full shoulder), very restricted movement - can not raise. Throbbing preventing sleep.  Ongoing, have used Advil and ice with no improvement. Chills & Fever - starting c. 26 hours after injection, continuing to increase (now 30 hours post vaccine) Headache - onset c. 18 hours post injection General - Tired / achy. Back pain. Burning eyes.   All ongoing and worsening.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal chest pain, Pustule
Clinical narrative: On night of 30th of March, she felt some soreness to chest area and took Tylenol to help sleep. In morning she noticed a dime size spot that was red and painful and had a peak to it with a pus discharge.  She said the pain subsided around midday on 31stof March but it is still red and visible.  It is located between neck and breast area in middle of chest.  Only one spot. She said she is not sure when the spot came about but only noticed it on the night of 30th of March.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood glucose, Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement
Clinical narrative: blood pressure dropped really low; pulse went really high; heart rate went up; atrial fibrillation; his blood pressure and pulse have remained erratic; his blood pressure and pulse have remained erratic; This is a spontaneous report from a contactable consumer.   A 76-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 10:30 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), at the age of 76-years at vaccination, as SINGLE DOSE for COVID-19 immunisation  .  Medical history included congestive heart failure, aortic valve replacement couple of years ago. Concomitant medication includes aspirin 325mg once per day by mouth. On 05Mar2021, the patient went into Afib, his heart rate went up and the next day on 06Mar2021, his blood pressure dropped really low but his pulse went really high and carried it that way for a few days and then he went pretty much back to normal.  On 05Mar2021, the patient experienced atrial fibrillation for 22 hours and since that time his blood pressure and pulse have remained erratic. The reporter stated that the patient has returned to normal and his pulse is still a little high and his pulse used to run in the 70's and maybe 80 but today (15Mar2021), the pulse was still 95; on 06Mar2021, the patient took his blood pressure twice and is not sure at what time he checked it but one time it was 98/65 and the pulse was 114 at that time and the other time the blood pressure was 88/59 and the pulse was 115. States the patient's blood pressure pretty much turned back to normal on 10Mar2021 and the blood pressure started being normal on 10Mar2021. On 15Mar20021, the patient's blood pressure was 140/76 and the pulse is still real high at 95 today and he weighs himself, takes his blood sugar and blood pressure every day. Regarding the treatment, the reporter and the patient saw the patient's cardiologist this past Friday 12Mar2021 and put the patient on Metoprolol and the blood thinner Eliquis; states the patient was just taking a whole Aspirin and had previously had aortic valve replacement a couple of years ago and the HCP reduced his aspirin dose down to a low dose of Aspirin and then put him on the Eliquis at the HCP appointment. The reporter stated, for the Metoprolol and Eliquis she does not know the dosages or frequency of how the patient takes them at this time; states she has no lot numbers for the Metoprolol, Eliquis or Aspirin to provide as they are not with her at this time. The outcome of the event his blood pressure and pulse have remained erratic was not recovered; while the other events was recovered. Treatment has been given for the events.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Pulse pressure increased, Weight
Clinical narrative: blood pressure dropped really low; pulse went really high; heart rate went up; atrial fibrillation; his blood pressure and pulse have remained erratic; his blood pressure and pulse have remained erratic; This is a spontaneous report from a contactable consumer.   A 76-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 10:30 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), at the age of 76-years at vaccination, as SINGLE DOSE for COVID-19 immunisation  .  Medical history included congestive heart failure, aortic valve replacement couple of years ago. Concomitant medication includes aspirin 325mg once per day by mouth. On 05Mar2021, the patient went into Afib, his heart rate went up and the next day on 06Mar2021, his blood pressure dropped really low but his pulse went really high and carried it that way for a few days and then he went pretty much back to normal.  On 05Mar2021, the patient experienced atrial fibrillation for 22 hours and since that time his blood pressure and pulse have remained erratic. The reporter stated that the patient has returned to normal and his pulse is still a little high and his pulse used to run in the 70's and maybe 80 but today (15Mar2021), the pulse was still 95; on 06Mar2021, the patient took his blood pressure twice and is not sure at what time he checked it but one time it was 98/65 and the pulse was 114 at that time and the other time the blood pressure was 88/59 and the pulse was 115. States the patient's blood pressure pretty much turned back to normal on 10Mar2021 and the blood pressure started being normal on 10Mar2021. On 15Mar20021, the patient's blood pressure was 140/76 and the pulse is still real high at 95 today and he weighs himself, takes his blood sugar and blood pressure every day. Regarding the treatment, the reporter and the patient saw the patient's cardiologist this past Friday 12Mar2021 and put the patient on Metoprolol and the blood thinner Eliquis; states the patient was just taking a whole Aspirin and had previously had aortic valve replacement a couple of years ago and the HCP reduced his aspirin dose down to a low dose of Aspirin and then put him on the Eliquis at the HCP appointment. The reporter stated, for the Metoprolol and Eliquis she does not know the dosages or frequency of how the patient takes them at this time; states she has no lot numbers for the Metoprolol, Eliquis or Aspirin to provide as they are not with her at this time. The outcome of the event his blood pressure and pulse have remained erratic was not recovered; while the other events was recovered. Treatment has been given for the events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electromyogram, Hypoaesthesia, Joint range of motion decreased, Sleep disorder
Clinical narrative: 30 minutes after, ring finger and middle finger went numb. 2 hours later was unable to lift arm. that evening terrible pains, could not sleep, no function in arm for 3 days. the pains felt like I tore my rotator. I felt my shoulder was broke. still have issues now have moved into elbow and hand goes numb some. lifting is hard.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: 30 minutes after, ring finger and middle finger went numb. 2 hours later was unable to lift arm. that evening terrible pains, could not sleep, no function in arm for 3 days. the pains felt like I tore my rotator. I felt my shoulder was broke. still have issues now have moved into elbow and hand goes numb some. lifting is hard.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness lightheaded after 5 minutes of the vaccine.drank water and felt better. 126/84, 74, 100% RA
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Small raised red bumps appeared on hands/fingers approx 10 days post vaccination. Bumps were itchy and grew in size within 24 hours. Affected areas were not pus-filled and have responded moderately to antihistamine topical cream and cetirizine orally.  Quantity of affected bumps has decreased since initial outbreak, however new spots are still appearing. Patient is currently on day 10 of outbreak.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: shot given 3/11/21, on 3/16/21 a red rash that itched, burned and stung appeared from head to toe.  Dr. prescribed a steroid MethylPREDNISolone 4 mg tablets on 3/17 or 3/18 and about 3/22 the rash was gone.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: Fatigue
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt. presented with hives and became short of breath. Benedryl 50mg IM. Pt. signed AMA.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness
Clinical narrative: On Wednesday, March 31, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER8737, EXP 7/2021) at approximately 11:12am. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness and pressure on chest" at 11:35am and vitals were taken by EMT. Vitals at 11:35pm: HR: 85bpm, 02 sat: 97%. Lead PHN was alerted and vitals were taken again at 11:40am. Vitals: BP: 120/70. Client was walked over and seated on the anti-gravity chair with a bottle of water. Vitals at 11:50am: BP: 122/74, HR: 90, 02 sat: 98%. Vitals continued to improve and client stated the "pressure on chest and dizziness" was completely gone 20 minutes later. Reassessment of vitals were were offered at 12:30pm but were refused by client. Client was observed for an additional 30 minutes in Observation area. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on mobile reporting app. Client left vaccination site at approximately 1:00pm with a steady gait.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: On Wednesday, March 31, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER8737, EXP 7/2021) at approximately 11:12am. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness and pressure on chest" at 11:35am and vitals were taken by EMT. Vitals at 11:35pm: HR: 85bpm, 02 sat: 97%. Lead PHN was alerted and vitals were taken again at 11:40am. Vitals: BP: 120/70. Client was walked over and seated on the anti-gravity chair with a bottle of water. Vitals at 11:50am: BP: 122/74, HR: 90, 02 sat: 98%. Vitals continued to improve and client stated the "pressure on chest and dizziness" was completely gone 20 minutes later. Reassessment of vitals were were offered at 12:30pm but were refused by client. Client was observed for an additional 30 minutes in Observation area. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on mobile reporting app. Client left vaccination site at approximately 1:00pm with a steady gait.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Fever Chills Body ache Dry Cough Nasal Congestion  Lymph nodes inflammation on the side of the injection  Tiredness Injection site pain Left cheek inflamation
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, Swelling face
Clinical narrative: Fever Chills Body ache Dry Cough Nasal Congestion  Lymph nodes inflammation on the side of the injection  Tiredness Injection site pain Left cheek inflamation
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cellulitis, Chills, SARS-CoV-2 test negative, Skin operation
Clinical narrative: I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever.   On Saturday I was better but still weak and that is when cellulitis started in my left leg.  On March 7, 2021, I was seen in the ER.  I was given a shot and antibiotics and told to return if not better.  So on Monday, March 8, I returned to ER and then was admitted to the hospital.  I was allowed to go home on Saturday, March 13.  Since then I had two sores to develop on my left leg.  I had to have wound surgery on them on March 25.  I am a lot better but still not completely well.