chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm.
RASH ON NECK AND CHEST  LUMP UNDER LEFT ARM BY ARMPIT WARM TO TOUCH HARDENED SPOT WHERE INJECTION WAS GIVEN   EMPLOYEE TOOK IBUPROFEN. SYMPTOMS LASTED ONE WEEK.  SYMPTOMS ARE TOTALLY RESOLVED PRESENTLY.   SYMPTOMS NOT REPORTED UNTIL 2/8/2023
PT c/o difficulty breathing/swallowing approximately 15 min post PNP vaccine. Pt given 50mg IM BENADRYL and placed on 2L O2. EMS called. Pt with HR 150's, Resp rate 30's, pt c/o dizzines and pt was diaphoretic. Pt sent to ER via EMS.
On 8/3/00 pt phoned with a complaint of swelling at ankles, knees and wrists. Pt saw PMD on 8/8/00 and at that time, swelling was resolving. Condition continued to improve and eventually resolved.
see addendum.  Description of reaction to moderna vaccine #2 (rash): rash, visit 4.12.21, started within 1-2 days of moderna vax#2. exam: fading scattered erythematous patches, small, some in ring like distribution (right thigh). 4.27.21: Rash is patchy, sl raised, scaled, excoriated, no central clearing, not clearly round. Not clearly hives. Doubt fungus (more excoriated). Not better with topical/oral benadryl. Intensely itchy. Rx cetirizine, topical triamcinolone. aveeno oatmeal bath. moisturizer. 5.25.21: rash is better. mild lichinification lower pretibial areas. DDX includes lupus (doubt), insect bites, eczema/atopy, medication reaction, doubt psoriasis/pemphigus, contact dermatitis. 7.2.21: rash persists: Scattered maculopapular lesions sl raised, pink, various stages of evolution, may excoriate or unroofed w/o ulceration, no vessicles, scatters on BLE > BUE, few on upper back and lower abd. Punch Biopsy done left thigh. 7.13.21: rash fading.No longer itching, uses skin lotion.
4APR98 devel fever, vomiting, cough, increasing irritability;6APR98 spinal tap, adm to hosp;dx pneumococcal meningitis w/evidence of inc intracranial pressure;7APR98 transferred to another hosp intubated;
vax given @ noon 16NOV @ 545PM same day had sudden onset of fever, muscle aches, jerky muscles, was not able to see;taken to ER t102.6;APAP given;BC & ABG's done; temp down; pt also states passed out for a few mins & throat got tight
Dizziness for several days, headache, chills, trouble sleeping, nausea, racing heart rate
The patient was an unfortunate 68-year-old white female with very complicated medical history, who was initially admitted to hospital on December 13th, for respiratory failure and altered mental status.  ABG revealed a severe respiratory acidosis.  She was intubated immediately.  She had a prolonged complicated hospital course significant for severe sepsis with shock, pneumonia, acute on chronic kidney disease, congestive heart failure, and possible C difficile colitis.  She received broad-spectrum antibiotics.  Efforts at ventilator weaning were unsuccessful.  She was then transferred to facility on December 29th.  An echocardiogram revealed an ejection fraction of around 60%.  Moderate right ventricle enlargement.  Mildly decreased right ventricular systolic function.  Estimated systolic pulmonary artery pressure of 61.  Severe right atrial enlargement.  2+ MR and moderate PR.  She underwent diuresis.  Empiric antibiotics were resumed.  Unfortunately, she steadily clinically worsened.  Renal function worsened and she began to struggle with hyperkalemia.  She was largely maxed out on ventilator support.  She was continued on cyclosporine.  Heparin drip was provided for anticoagulation given her atrial fibrillation.    Given her multiple medical issues, poor prognosis, and clinical deterioration, had an extensive discussion with her son.  Code status was made DNR and care was withdrawn.  She was comfortable.  She was extubated and pronounced dead at 1:22 on January 5, 2023.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4287870-00 (Agency).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jul2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1154508) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. he following information was reported: COVID-19 (medically significant) with onset Dec2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The action taken for upadacitinib was unknown.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of covid and drug ineffective with Rinvoq (Upadacitinib) was no reasonable possibility.  Causality for Pfizer BIONTECH covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of covid and drug ineffective with Pfizer BIONTECH covid-19 vaccine (Tozinameran) was possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: WELLBUTRIN; ADVAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: During the week I tested negative; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received vaccine and other medication in 2 weeks (Welbutrin 450 mg and Advair Discus 250/50).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
6 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA281961 and 2019SA282007 (same reporter).  This case involves a six years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
My daughter was fine that first 30 minutes. When we got home she had chills and had a rash on both her legs above and below her knees. I bundled her up and within 20 minutes was okay. I monitored her and there was no other issues than diarrhea later
15mon. male w/ hx of recurrent ear infections & measles in Feb. 89'. 5Apr89 was given MMR. Within 24 hrs /p vaccine, parents noted hearing deficit, confirmed by physician exam.
No additional AE reported; Customer reported that an expired ROTATEQ was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 59-day-old male patient. Information regarding his concurrent conditions, concomitant therapies and medical history was not provided.  On 14-APR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, lot # 1707502, expiration date 31-MAR-2022 for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
felt tired and weak/was very weak, can't pick up heavy things/Weakness; excessive sweating in her feet/Feet were sweating; muscle pain/muscular pain; had pain in the bones; fatigue; short of breath; nausea; stomach is different/ stomach feels different/she felt stomach congestion, she felt a "bad stomach; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation. Medical history included asthenia (felt weak back in Aug but they said it wasn't anaemia), blood cholesterol increased (high cholesterol but that is under control now) and overweight. The concomitant medications were not reported. The patient received first dose of Pfizer-BioNtech Covid-19 vaccine on 05Mar2021, she has second dose scheduled on 26Mar2021. On 05Mar201 the patient experienced stomach congestion, she felt a "bad stomach,"  she felt her stomach was sick, she had nausea for 3 days, at night she felt tired and weak, she also had muscle aches and excessive sweating in her feet, she still has this last symptom. She would like to know if these symptoms were normal. She felt her stomach was different. From that morning, she felt nausea for 3-4 days (on 06Mar2021). Now sometimes the caller had fatigue, feels down, she had some questions. The nausea was for 3-5 days. She felt totally different, no power, short of breath, she was typically very healthy. Was this normal, was these allergies, and should she get the second dose of the vaccine? The nausea lasted about 3 days then it stopped so she doesn't have stomach issues, then she had more symptoms. Feet were sweating which also happened sometimes. She had shortness of breath, but it was more controlled. She also has muscular pain and felt weak and had to gasp for air when she had the loss of air. She also had pain in the bones, was very weak, can't pick up heavy things. After the nausea she felt weak, it had been at least 3 days. The outcome of the event nausea was recovered on 08Mar2021 while for rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Left eye is swollen and the left side of her neck and left shoulder feel itchy  Took oral Benadyrl
Pt vaccinated with MMR experienced weakness & loss of sensation in distribution of radial nerve distal to injection site.
The child who came to our clinic on 9/23/22 for an MMR for school.  Unfortunately, the clinic staff didn't see that they received a varicella on 8/29/22.  So the MMR was given 25 days after the varicella, not the full 28 days; therefore is "NOT VALID"; given too early; no negative health outcomes.
pt devel bruising of the skin & tongue w/petechia on the buccal mucosa;dx w/ITP & hosp; pt discharged following day & had uneventful recovery
Dec 23 evening - experienced itchiness on head and arms Dec 24 morning - woke with allergic reaction symptoms -> severe itchiness/hives on torso, arms and head, acid reflux, shortness of breadth, low energy, took over the counter Benadryl every 4 hours throughout day, symptoms got better Dec 25 morning - woke with allergic reaction symptoms -> severe itchiness/hives on torso, arms and head, acid reflux, shortness of breadth, low energy, took over the counter Benadryl every 4 hours throughout day, symptoms got better Dec 26 morning - woke with allergic reaction symptoms  at 1am -> severe itchiness/hives on torso, arms and head, acid reflux, shortness of breadth, low energy -> went to The local hospital ER, administered steroid, Zyrtec and Pepcid and released Dec 26 day -symptoms got better up until 2pm then declined again Dec 27 morning - woke with allergic reaction symptoms  at 1am -> severe itchiness/hives on torso, arms and head, acid reflux, shortness of breadth, low energy -> administered Epi pen for tree nut allergy, went to The local hospital ER, administered steroid, Zyrtec and Pepcid and released Dec 27 day - prescription picked up for aforementioned medicines, started that during the day symptoms improved Dec 28 day - saw primary care -> no confirmed diagnosis, symptoms NOT for food allergy, suspect symptoms from Moderna booster shot administered on Dec 14, did blood work Dec 29 day - blood work indicated possible blood clot and infection Dec 30 evening - had CT scan of torso performed -> no blood clots Dec 31 - Jan 5 - symptoms are hives on skin on arms and head when irritated or scratched, shortness of breath at times, acid reflux at times, elevated resting heart rate ~80bpm (typically 60), lower energy level
Covid positive exactally 7 days later; Severe pneumonia 2 days later; fever; chills; fatigue; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 16Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single (at the age of 62 years old) for COVID-19 immunisation.  Medical history included thyroid disorder, blood pressure abnormal and blood cholesterol abnormal.  The patient experienced Covid positive exactly 7 days later 25Aug2021. Severe pneumonia 2 days later fever, chills, fatigue within 48 hours of shot on 18Aug2021 02:00.  The patient required physician and emergency room visit. The patient received treatment. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow-up.
today rash spread throught body;fever 99.2 this AM;saw MD & dx w/strep infect & ear infect rt ear on meds;
1220PM flat, reddened area devel @ site of vax w/minimum amount of swelling; ice applied, alternating off q 10mins
devel hives upper torso; no redness @ inj site;several hrs p/vax
Right shoulder limited range of movement; chronic upper right arm discomfort/pain with movement.  I didn't know this could be a possible side effect  related  to the COVID vaccine until I saw an article in a local newspaper about SIRVA.  As a result, I have not been to a doctor to discuss this problem.
Information has been received from a physician concerning a female medical student who may have been vaccinated as a child with Varivax. On 24-MAR-2006 it was reported that the patient had a "recent" titer drawn which showed low immunity to varicella. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot/batch expiry date were not reported). On an unknown date the patient got shingles at an unspecified time following the vaccine. The outcome of the event was unknown. Additional information has been requested.
Post vax the patient developed a painful area of redness and slight induration over the injection site about 8cm in diameter. The patient complained of a flare up of carpal tunnel syndrome with wrist and forearm pain, and paresthesis in the first 3 fingers.
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient received medical care for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses like medical losses and cost for hospitalization, physician care, monitoring, treatment, medications and/or supplies; diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages.  The outcome of shingles was not recovered and the reporter considered this event to be related to zoster vaccine live(ZOSTAVAX).
Erythema,swelling and pain at injection size approximately 5 cm in size.  Treated with cool or warm compress, aleve prn and f/u prn
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Swelling in Armpit; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling in armpit on an unspecified date. The reporter wanted to know if it was normal to get swelling in armpit seven days after getting the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
The patient was given the 2nd dose 1 week too early.  No adverse reactions currently.
REPORTS SEVERE PAIN AT SITE AT THE TIME OF THE INJECTION.  DEVELOPED CONTINUOUS PAIN IN LEFT UPPER ARM WHICH BEGAN TWO DAYS AFTER THE INJECTION. ALSO REPORTS LIMITED RANGE OF MOTION. REPORTED AN INCREASE IN THE PAIN AFTER AN EMG TEST WAS DONE.
Low-grade fever, shaking chills, fatigue (especially in legs, which felt heavy), and headache began about 12 hours after shot and then ended within about 24 hours of onset, except for the fatigue. Mild fatigue, mostly in legs, persisted for over a month and then gradually got better and I think now it's gone (roughly 2 months after shot).   Also, I skipped a menstrual period; my period was due during the first few days of June but didn't start until July 1. The complicating factor is that I'm 51, and though I've never missed a period before, I know menopause has to start at some point. So I'm not sure whether the missed period is an effect of the shot, or the start of perimenopause/menopause.
Information has been received from a physician concerning a 15 year old female with unknown medial history, who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL. Subsequently, on an unknown date, immediately after being vaccinated, the patient experienced syncope. The patient was fine before leaving the office. No lab diagnostic studies were performed. Subsequently, on an unknown date, the patient recovered from syncope. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 14 year old female with no pre-existing allergies, birth defects, or medical conditions, who on 20-FEB-2008, in the PM, was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot # reported as "12676"). On the same day, 20-FEB-2008, in the PM, she was also vaccinated intramuscularly in the left arm with a first dose of ADACEL (Lot # C2942AA) and intramuscularly in the right arm with a first dose of MENACTRA. Subsequently, on 20-FEB-2008, immediately after being vaccinated, while obtaining a CBC fingerstick, the patient fainted, pallor noted, bradycardia, with a heart rate 45, and normal BP and DXT. The patient's feet were elevated and laid supine. The patient recovered with in five minutes. Heart rate was normal 70's (lying down) and 90 (standing), and regular rhythm noted. The blood pressure was 126/82 and glucose was 105. The patient was seen by a cardiologist. The patient was fine before leaving the office. No product quality complaint was involved. No illnesses at the time of vaccination were noted. Additional information is not expected.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Excessive pain in arm . Fever with chills, chattering teeth. Strong head aches. Aches in legs and arms and all joints. Feeling like "crawling ants". Stomach ache and nauseated. Loss of appetite and unable to eat and drink. Couldn't get warm. Endured 2 days, first day very strong, second day  milder.  Diarrhea during the night after second day.  On the third day still no appetite and feeling weak. I am still normally very active and alert.