chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have broken out in welts all over my body and I am itching like absolute crazy; I have broken out in welts all over my body and I am itching like absolute crazy; My face is red as a bee and I even got it on my legs and my arm; all for my feet and legs are covered with white, itch spots; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at the age of 84-years-old, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetes, and allergies. Concomitant medications included unspecified medications. The patient got the COVID vaccine on 18Jan2021 and she has been okay until last week. The patient has broken out in welts all over her body and was itching like absolute crazy on Jan2021. She went to her doctor on Friday but couldn't see him because he had too many people, but she asked a PA (as reported) to tell the doctor to see him. The doctor wanted to know what she has done. She mentioned that she has been at her house ever since last March because of the virus. She hasn't even been to a grocery store or anywhere. She was given ZYRTEC, PEPCID, and something to put on, it's Triamcinolone to put on twice a day. She mentioned that Triamcinolone has been helping her since Friday, but now it's not doing a thing. She was just scratching. Her face was red as a bee and she even got it on her legs and arm. It started on her hands and now, it was going up her arms. This started a week ago (Jan2021). She was suffering from the symptoms, all her feet and legs were covered with white, itch spots and they all go together. She mentioned that she was going to see another doctor tomorrow or go to the hospital or somewhere again. She couldn't stand this and added that you don't understand how serious this is. She was supposed to get the second shot tomorrow and mentioned that she was afraid to get it. The patient underwent lab test and procedure which included A1C with an unknown result on an unspecified date. The outcome of the events was unknown.
The first Moderna shot on 4/6/2021 was fine with no reaction. The second Moderna shot on 5/5/2021...the arm  one week later was red/sore... By the 11th of May, I had chills, joints were sore, slight fever, fatique....then within days... a head ache  from my forehead that wrapped around down my left side of face (which was quite swollen under my eye (red) as well as cheek and painful to my left ear and back of head.  This has lasted since the llth of May.. Went to doctor (primary) on the 18th of May and he took notes and gave me the antibiotic Azithromycin 250 mg.  Today, the 20th, when I woke up my eye was still looking like it was pushed back. When I look in the m;irror, one eye looks bigger than the other and one looks like is has receded in my face..
Rt side of face & rt ear painful (constant) unrelieved by Tylenol-feels very weak. Pain started 14Feb91 1230 am.
Fever 24 hours later. Peak temp 101.8. Fever dropped with Ibuprofen. 48 hours later, low fever and chills returned 99.1 peak temp accompanied with irregular heartbeat. Irr. heartbeat lasted several hours. Peak - skipping a beat for every 5 beats.
Overall, critical condition with poor outcome. Discussed with patient's daughters 8/13. I explained that the patient is deteriorating gradually and I agrees with comfort measures. On 8/14, discussed with the patient's son at bedside, all questions answered. I also called the POA updated on the patient current condition. Family will meet today and update us on their plan of care. Addendum 3 PM on 8/14: Family had a meeting about goals of care, all questions answered. Family decided to proceed with comfort measures. Will add Ativan and Morphine. Will continue high flow oxygen as per family request. Will continue to monitor. Discussed with the RN.  Expired peacefully 8/15/2021
Patient received the first vaccine 03/04/2021.  Patient was contacted to return to the clinic for his second injection and patient received the second injection 03/16/2021.  Scheduling staff contacted the patient to schedule the second dose and the patient stated he had already been to the clinic and had received the second dose.  Scheduling staff notified the clinical supervisors of the event.  Patient was contacted by telephone 3/25/2021.  Patient stated his arm was sore after each vaccine and he had a headache the day after the second vaccine, but no other adverse reactions were reported.  Patient was instructed that he should not get the series repeated and patient was instructed to notify the clinic with any questions or concerns.  The patient was receptive with conversation.
As noted earlier, I?m not sure it?s related at all, but getting the shot is just one of the few things different in my life since the symptoms have appeared. I have had frequent arrhythmia (extra beat and skipped beat combinations), several per minute at times and this is gone on for a couple of weeks. I?ve experienced before only one very short on sleep.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hashimotos thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; NOVOLIN 30R [INSULIN]; LEVOTHYROXINE; PANTOPRAZOLE; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: rebound with symptoms worse than the original. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 27Jun2022 to 02Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient did not disclose that she had already received the Johnson & Johnson vaccine in March 2021, and she received the first dose of the Pfizer vaccine
8/5/2021:  CC: Congested and headache. Patient states when she woke up this morning she was having tremendous difficulty swallowing and noted that she was unable to speak.  When she tried to speak she states her low words were all slurred and garbled. She did complain of mild dizziness. A CT scan of the brain showed old lacunar infarct in the right thalamus, and noted chronic right sphenoid sinusitis suspicious for mycetoma.  There is no 12 lead EKG for review.  Her BP was 209/94 on admission.  Patient stated she did not take her antihypertensive medications this morning.  She was treated with intravenous hydralazine and labetalol.  The patient also states she has been having a nonproductive cough. Patient tested positive for COVID-19 on 8/5/2021 following admission. Of note, patient previously received Pfizer COVID-19 vaccine, last dose in April 2021. 8/7/2021: Patient discharged home
Pt felt "off" some minutes after receiving vaccine. reported to staff and fainted upon standing.  eased her to floor and elevated legs. regained consciousness immediately.  called 911.  heart rate low blood pressure normal.  clammy before faint quickly regained color.  EMS took over and transported pt to hospital
no reaction - extra dose pt was given an extra dose. no adverse reaction Database Did not show that 1st dose was already given
experienced an event which was not known at the time of this report; This case was reported by a physician via sales rep and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an event which was not known at the time of this report.   The physician did note that this event was unlike he experienced using Shingrix previously. The reporter consented to follow up.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On 12-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees Centigrade for 19 hours. No adverse effects were reported. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006245, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
No additional AE reported; the patient was administered PROQUAD on 06-JAN-2021 that had a labeled expiry of 05-JAN-2021; This spontaneous report as received from a registered nurse and other health care professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA)(PROQUAD) lot # S021324, expiration date: 05-JAN-2021, 0.5 ml (route of administration and anatomical location were not reported) for prophylaxis. No adverse event was reported. Additionally, information regarding re-vaccination recommendations was requested by the reporter.
HPI: This is a  33 Years old  Male  presenting with chest wall pain for 5 days s/p moderna covid vaccine.  Patient indicates that he has felt short of breath at times. Patient is able to reproduce pain to right lower rib area.  Pain started gradually.   It is described as dull and aching, radiating into nowhere.   Pain is described as moderate upon onset and is currently mild.  No history of the same.   Pain is not worse with exercise. Patient has no decrease in exercise tolerance recently.
Pt received J/J vaccine at location yesterday  (3/4/21) at 11am.  She noticed a fever at around 3pm.  She had a fever to 104-105 all during the night, she was 99 this am.
swelling in bicep in opposite arm from injection; swelling is very sore; arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection), VACCINATION SITE PAIN (arm is sore at the injection site) and VACCINATION SITE SWELLING (swelling is very sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection) and VACCINATION SITE SWELLING (swelling is very sore). At the time of the report, PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection), VACCINATION SITE PAIN (arm is sore at the injection site) and VACCINATION SITE SWELLING (swelling is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not provided. No treatment medication provided by the reporter.   Reporter did not allow further contact
Shingles after my 1st shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. In September 2022, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022  Reporter's Comments: This case was reported by a consumer via interactive digital media  The patient received first dose of Shingrix vaccine and had shingles before receiving the 2nd dose.  The patient asked when he/she should receive the 2nd shot of Shingrix vaccine. The reporter just wanted to know GlaxoSmithKline recommendations.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Patient reported and showed a redness and swelling at injection site. Red area was about 1.5" in diameter. Patient also reported itchiness and discomfort. This appeared in the morning after the vaccination was given.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # reported as M018635, expiration date 11-OCT-2017. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
No additional AE's/PQC's; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 09-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T020652, expiration date 26-JUN-2022) for prophylaxis. The vaccine administered experienced temperature excursions of -13.9 degrees Celsius for 45 hours recorded by data logger. There was no previous temperature excursion. No additional adverse effect reported.
pt recvd flu vax & devel sl edema & redness @ the inject site; pt also exp numbness; Pt treated w/DPH;
Severe urticaria, dyspnea, throbbing h/a. Was tx with BENADRYL and SOLUMEDROL with instructions to repeat BENADRYL q 4-6 hours for next 24hr. Pt. returned to ER 12AM c/o SOB. Tx of epi & nebulizer tx done Being followed by MD.
Dizzy; Nauseated; Headache; Chills; Feeling crappy; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that.  A 74-years-old female consumer received bnt162b2 (COVID-19 Vaccine,  formulation: solution for injection, Batch/Lot Number: EN6201, expiration date was 30Jun2021) via intramuscular, administered in arm left on 17Feb2021 11:30 as dose 1, single for covid-19 immunisation (age at vaccination was 74 years). Medical history included Polycythemia Vera (reported as poly something vera), she had that gene, where her body makes more red blood cells than normal from an unknown date and unknown if ongoing and she gets phlebotomies every couple of months and seasonal allergy from an unknown date and unknown if ongoing and she did not know what they are but when there was pollen out, she gets all stuffed up and sneezes. The patients concomitant medications were not reported. She received her first Pfizer Covid-19 shot on 17Feb2021 and called to report her symptoms. About 2 hours after the shot on the same day 17Feb2021, she felt a little dizzy like she was going to pass out. However, it went away just as fast as it came, and she was fine. She had the shot around 11:30 A.M and at about 5:30-6:30 PM, she became a little nauseated. She had a headache, chills and was feeling crappy. She did not had fever or swelling of the face, none of that. However, these symptoms just came and went. One day before the day of report, at around 2:00pm which was about 24 hours later, she felt really good and fine. However, she got up in the morning and had a little nausea, headache, chills, and just felt crappy. Caller wanted to know how long these symptoms will last and declined to include a healthcare professional for this report. Vaccination facility type was a mall. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as not applicable. No other additional Vaccines received on same date of the Pfizer Suspect. Adverse events did not require a visit to emergency Room or physician Office. Prior Vaccinations within 4 weeks was reported as none. NDC number of COVID-19 Vaccine was reported as unknown. She did not receive any other products and had no history of investigation assessment done. Outcome of these symptoms was reported as either staying the same or improving. At the time of report, she did not have headache or nausea. The outcome of the events dizzy, chills and felt crappy was recovering and nauseated and headache was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
I was incoherent my memory started fading. I was even forgetting who I was. Just a few days after I was taken to the hospital. Where I had not knowledge of what happened to me. My relatives described it as I didn't even know who I was.  Upon arriving at the hospital they had me hook up on antibiotics.  Then found I had a rare infection most the doctors have never seen. This infection was endocarditis. They put me the strongest antibiotic vancomycin. I spent a few months in the hospital and I am suffering bad from it.
HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced headache. On 28-OCT-2021, the patient experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and nausea. This report was non-serious.
Patient felt anxious then began feeling uncomfortable that progressed to feeling nauseated.  Pt initially not able to sit still in her seat in the vehicle.  Breathing fast.  Pt stated she felt her fingers tingling.  Panic type attach with history of this similar type event after receiving other needle injectable medications.     Pt calmed down after being evaluated further by Medic unit called to the scene.  Pt returned to normal and signed refusal form after risks explained to her.  Transport to ER offered multiple times, but patient stated she feels better and signed refusal form.
Pt stated arm hurt, was initially numb for first couple of days. That resolved but pain persists from shoulder to hand Tylenol and ibu have not helped.
developed Graves' disease and Hashimotos. Not sure if its coincident or not. Also received the German Measles vaccine.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 16-MAR-2015 the patient was vaccinated with VARIVAX (Merck) which was administered via intramuscular (dose and lot # were not reported). It was reported that the patient received VARIVAX (Merck) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
I have essential tremor that is usually mild. Overnight, my tremor was greatly exacerbated and continued for several hours before becoming my usual state. I  had the same reaction to the first dose and that one I reported to the manufacturer.
She became a lot more tired about the 2 or 3rd day after vaccine. Then in August suddenly her legs wouldn't move. She was scooting. To get from her chair to the restroom took much longer than before. Her legs continued to get worse. I called the ambulance and had them come get her because her legs wouldn't move at all. The right side of her body has become bad and very little strength in her right arm. She did mention her right arm was sore. She was admitted into the hospital for 7-8 days on August 31st. They ran a lot of tests, and they did fine lesions on her brain. She is currently in the rehab center. She still not doing very well.
Vaccination expired 9/30/2023 and administered after expiration date on 10/3/2023.
8/13/2021  Complaining of shortness of breath, fatigue and body aches x 2 days.
5mins p/shot onset of hives, arm worse where shot given, across chest-itchy;no swelling, SOB; tx DPH
Pt received vaccine and went to sit in observation area. Stated did not feel good, lost consciousness and fell out of chair. Another party stated that pt appeared to be convulsing. Pt regained consciousness within < 1 minute, and was seated in chair, given water. EMS was called and responded to evaluate patient. Further course by EMS is unknown.