chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some arm soreness around injection site, chills, then body aches and headache.  The worst seemed to be heart palpitations.  My heart began racing to about one and one half the normal to a rate of 100, at about 30 hours after the injection.  It then slowed to 50 bpm for about 15 minutes before racing back to 100 and becoming somewhat irregular, slow pace followed by several quick beats then a beat or two slow again and then several quick beats.  This lasted for a few hours and then I fell asleep.  When I woke up about 7 hours later, it was back to normal.  Some slight body ache and headache.
In December 2022 I had cold-like symptoms but I had a fever of 102-103. I took a COVID-19 test and it was positive. The doctor called me and asked me to go to the doctor to check my kidney function so they would know which type of PAXLOVID to prescribe. I had runny nose and congestion only last for about five. I also lost my sense of taste and smell.  I still have not regained 100% of my sense of taste or smell.
A week prior to event, patient had a miscarriage at 6 weeks gestation.  Then on 12/11 patient was down on her driveway by her fiance.  She was in cardiac arrest.  CPR was performed by EMS and pulse restored.   She arrived to hospital and again went into cardiac arrest.  CPR performed for 35 min.  Pulse again restored.  Patient is now brain dead and obtunded.  Patient is intubated and does not move to any painful stim.  She was found to have a saddle PE, a new acute DVT in the left lower extremity and clots in her kidneys.  Within 12 hours patient lost all core reflexes (corneal, gag and cough).  Pupils became fixed and dilated. Brain death testing will begin within 24 hours for confirmation.
burning sensation & numbness in legs, exacerbation of MS sx, spasms in legs for several days;took anti spasticity med for several weeks;
Lichen Sclerosus; spinal stenosis; trigger finger on the right hand; difficulty waking; dry mouth; My arm was sore after the pneumonia vaccine and the flu shot; This spontaneous report was received from a 86-year-old female patient via company, who was reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies was not provided.  On an unknown date in 2020 (reported as "last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Additionally, it was reported that her arm was sore after the pneumonia vaccine and the influenza vaccine (reported as "flu shot ") (pain in extremity).  On an unknown date in 2020, the patient had Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, difficulty waking (somnolence), and dry mouth, which started after the vaccination. The patient did not take any prescription medications.   Additionally, it was reported that the patient was allergic to an antibiotic that starts with an "e" and it caused her to have a severe long lasting headache but she cannot recall the name of the medication (class of product), but it was not reported if this happened before or after the vaccination.  The outcome of the events lichen sclerosus, pain in extremity, dry mouth, somnolence, trigger finger and spinal stenosis, and the causal relationship between the above-mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine were not provided.
Physician reported that patient received a Prevnar vaccine on 11/03/2000, and five hours post-immunization, she developed vomiting. The event lasted 24 hours. The patient recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Prevnar.
Shot on Tuesday, on Wednesday developed fever of 104, body aches, extreme fatigue.  Treated with cold compresses & Tylenol.  Fever of 102 on Thursday with Tylenol, sore/body aches, on Friday down to 99;9 , fever gone on Saturday, body aches gone
Nerve pain throughout my body the night of the shot but especially at the bottom of my feet when walking. Every morning since when getting out of bed,  I struggle with nerve pain across the bottom of my feet. It feels similar to shingles or walking on hot coals. It started to go away after 3 weeks but it  intermittently  returns.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with ROTATEQ with lot number K016279 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0169), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: FH2087), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "implanted amplatzer cribriform to close PFO from a few TIA's" (unspecified if ongoing), notes: implanted amplatzer cribriform to, close PFO from a few TIA's. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (17May2022) Negative, notes: 1st dose paxlovid 12May pm finishing 17May am and tested negative that morning (day 6); (24May2022) Positive, notes: on 24May symptoms returned and I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Dose 1: Site of injection:  Mild pain with swelling. Throughout rest of body:  Fatigue, Muscle pain, fever of 103 deg F, chills. These symptoms lasted < 24 hours. Became aware of a severe itchy area located on the shoulder/neck area of the injection arm which presented with a slightly raised circular small red spot occurring greater than 24 hours after vaccine injection, was visible ~ one to two days after injection. Also occurring, muscle pain and swelling in vaccinated forearm extending to ring finger and to a lesser degree to middle finger and thumb. Swelling and pain in ring finger does not allow complete extension or closure. Upon closing fist ring finger main knuckle becomes stuck and clicks to release, or needs to be pulled to release. Muscle pain did not allow me to lift items, such as a glass of water. 2nd Dose:  Moderna Lot: 020B21A on April 17, 2021, Intramuscular in left arm. Upon second vaccination dose had mild body symptoms again.  The skin reaction intensified to what appears to be uticaria, a rash of round, red welts on the shoulder skin that itch intensely. The  rash changed back and forth , spots increased becoming a deep red, changing to a flatter dry patch with scab features, then change to crusty with some fluid discharge, then back to deep red with some movement of spots.  The finger deformity also continues. 3rd Dose (booster): Pfizer Lot: FF2590 on November 10, 2021, Intramuscular in left arm. No body symptoms occurred. Skin reaction continues as above, presently at the dried scab-like phase and intense itch.  Have had additional pain in forearm muscles and ring finger is still affected.  March 26, 2022 It has been over a year now and my skin reaction continues.  The finger deformity has improved, some inflammation and pain continues.  The catch in my knuckle has improved however I can still feel the catch and the swelling does not allow me to straighten my ring finger.
Within 2-3 minutes after the injection, my lips started swelling and I started turning RED.  I immediately two a Benadryl, waited a few more minutes, and took another one.  I also held an epi-pen in my hand in case I needed it.  After about 20 minutes, symptoms started subsiding.  I took another Benadryl to be safe.  I have had about 50 analyphlaxis episodes and used lots of epi-pens because of the cutaneous mastocytosis.
We are having a difficult time conceiving; We are not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "We are having a difficult time conceiving"; MALAISE (non-serious), outcome "unknown", described as "We are not feeling well". The events "we are having a difficult time conceiving" and "we are not feeling well" required physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300053555 same reporter/drug, similar event, different patient;
Hearing loss in the right ear, R eustachian tube dysfunction, fluid in the ears began immediately after the 2nd vaccine.  In May 2021 I began having balance issues/dysequilibrium/vertigo.  My hearing loss is directly related to the 2nd vaccine.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # unspecified) in 2011 and the second dose (Lot # unspecified) on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
approx 1015PM child alerted parent to blotchy hives-neck, trunk & extremities;parent gave DPH upon waking 11/20/99;hives were clear;
2/6 very mild symptoms fatigue, achy, congested. Tested positive on an at home COVID-19 test, positive. Televisit with doctor. Prescribed PAXLOVID. Aches and congestions gone by day 5, fatigue lingered until day 7.
approximately 9 hours from time of injection patient presented back to ER with signs and symptoms of angioedema.
Vaccine administration error. This vaccine (approved for those ages 60+) was given to a 59 year old.   Reporting RN was administering vaccines at an offsite vaccine event where COVID, flu and RSV vaccines were being offered. Despite signage at the entrance to the event and announcements made during the event, this patient was not aware that the RSV vaccine was approved for those 60+. Patient visited check-in staff and requested all three vaccines. Patient was checked-in and was handed a prescreening form to fill out.  Check-in staff wrote "COVID+flu+RSV" at the top of this form, indicating that the patient desired to get all three vaccines as was the process.  Patient completed pre-screening form and presented it to this RN. This RN checked prescreening checklist for contraindications, but missed that his birthday was 1 year off- he was 59, not 60. Vaccines administered without incident. Upon charting later, RN noticed the error that had been made.
3RD DOSE MODERNA COVID VACCINE GIVEN 8/20/21, LOT # UNKNOWN;  4TH DOSE MODERNA GIVEN 4/12/2022, LOT #001M21A;  Pt had a positive COVID test on 1/30/22; admitted to the hospital; pt passed away in the hospital
13JUN93 pt ran t102 10PM had given APAP started sz 11PM & @ hosp ER t104 dx of ear infect released that noc; 26JUN93 sz & had t106 & red rash cause of both unk taken to ER stayed 3 hrs; dx viral infection; MD felt sz due to fever not vax;
Patient reports having a sensitive rash on her left arm, left armpit, and chest areas five days following vaccination.  Her physician, diagnosed her with shingles and prescribed an antiviral medication for treatment.
Breakthrough COVID-19 infection in fully vaccinated individual;  pt presented to emergency center +chest pain and longstanding cough, known +covid; currently inpatient and DNR limited code status, requiring supplemental oxygen
Patient received a Moderna Bivalent dose when they haven't received any previous dose. Following CDC website, we will wait 8 weeks before giving them their primary series.
itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; This is a spontaneous report from contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via intramuscular route on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included urticaria or hives from cold water from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after first vaccination, the patient experienced itchy and a burning sensation at the same time. Reported that, the side effects were mild. The patient's lips, perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days. The patient hypothesized that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. The outcome of the events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child who is under weight, came in the morning with a letter to receive his 3rd and last Hep-B vaccine. Father brought him; afebrile and no other complaints except pt does not eat well. Hep-B (Engerix-B) and PPD were done. 2 minutes, post vax, pt was sitting on a chair and slumped down and I don't know if he hit his head but father came to his aid and eyes were open. Pt recovered almost immediately. Temperature and response normal; asked "are you okay, and he nodded."
Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: Positive.         It was reported that the patient was taking other medication. The patient had 4 shots of the Moderna vaccine. He had the initial 2 shots and 1 booster.  After the 1st booster in Oct-2021, he got COVID-19 in Jan-2022, two months later. He had a monoclonal infusion antibody treatment.
This is an instance of breakthrough disease that resulted in death.   Death Certificate details are as follows:  Part I Cause of Death A: Acute Respiratory Failure B: Adult Respiratory Distress Syndrome C: COVID 19 Pneumonia Part II Other Significant Conditions: Acute Kidney Failure, Sepsis, Encephalopathy, Atrial Fibrillation, Coronary Artery Disease  The patient was admitted to the hospital on 09/08/2021. It is unknown if they were having symptoms, but the patient did receive  diagnoses of both pneumonia and ARDS so it seems that respiratory symptoms were likely.
Janssen Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 8/6/2021. PMHx of advanced parkinson, HTN, dysphagia. Presented to ED on 12/22/2021 via EMS with complaints of fever and hypoxia found to be septic due to cellulitis and Covid+. Prolonged hospital course with persistent respiratory failure, aspiration pneumonia, anxiety, and delirium. Transitioned to comfort care/hospice on 1/14/2022 and expired on 1/17/2022.
at night after vaccination, had chest tightness, tachycardia 140 with sob and oxygen 91% on pulse ox (with fever and flu like sx). still feels winded with exertion 9/7/21
Pt started with rash and fever of 102 on 05/30/2009 and continued with pruritic rash that developed into red oval shaped areas with vesicular lesion on each (like dew drop on rose petal) as seen upon exam by physician on 06/01/2009. Pt was given dx of Chicken Pox/Varicella.
Flu vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommend.
This literature report (initial receipt: 24-Apr-2012) concerns a 67-year-old female patient. In summer 2009, the patient received INFLUENZA vaccination (manufacturer unknown). One month later the patient developed pain and lump in the right arm reportedly in the same area that was vaccinated. Upon initial presentation her symptoms were presumed to be secondary to a torn triceps muscle. She was thus referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. The patient underwent incisional biopsy that demonstrated B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. The patient underwent CT (computed tomography) simulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanded by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. She tolerated the treatment well without any unexpected side effects. Physical examination at 1 and 6 months and 1 year after treatment revealed no palpable residual mass, swelling or skin erythema, or range of motion deficits. 6-month post treatment MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis (CT CAP) at 1 year showed no evidence of disease. Reporters comment: The relationship between influenza vaccine injection and the development of MALT lymphoma in this patient is speculative but is, undeniably, an interesting confluence of events. Although the available literature suggests that primary skeletal muscle non-Hodgkin lymphoma is associated with poor prognosis, the case presented here suggests that involved field radiation therapy alone can be an effective treatment for early stage primary skeletal marginal zone lymphoma.
pt recv vax & later that day felt bad & devel an inj site rxn w/redness & swelling;
Infant readmitted with fever and seizures at around 10 days of life.  Sibling with viral illness.  Sepsis workup negative; MRI shows multifocal encephalopathy consistent with viral process, likely not related to vaccine (but reported due to old DTP/encephalopathy concerns)Outcome uncertain, viral cultures pending and unclear if permanent disability will be present.  11/01/2007 MR received for hospital DOS beginning 9/13/2007.  12/18/2007 D/C Summary received for DOS 9/13-26/2007 with D/C Dx: Febrile Illness.  Suspected neonatal sepsis/meningitis.  Seizures.  Encephalitis.  Poor feeding. One week old infant developed fever and rash and was taken to ER and admitted.  In hospital pt developed seizure activity. Pt had some jerking movements c/w tonic-clonic activity. This resolved with meds. Neuro consult with hypotonia noted on PE. Developmental eval with impression: Encephalitis and seizure hx. Clinical picture c/w a viral encephalitis.  D/Cd with some diminished tone to be f/u as an outpt Follow up: May be too early to tell if he will have developmental delays. Currently within normal limits for milestones. 1/12/2010 Mild hypotomia and mild gross motor delay.
left elbow becomes paralyzed; on and off sharp left elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (left elbow becomes paralyzed) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy in 2007. Concurrent medical conditions included Drug allergy (Has a lot of medication allergies, but did not list them.). Concomitant products included LEVOTHYROXINE, AMLODIPINE, METOPROLOL, LISINOPRIL, GABAPENTIN, FORMOTEROL FUMARATE (PERFOROMIST), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (left elbow becomes paralyzed) (seriousness criterion medically significant) and ARTHRALGIA (on and off sharp left elbow pain). At the time of the report, PARALYSIS (left elbow becomes paralyzed) and ARTHRALGIA (on and off sharp left elbow pain) outcome was unknown.            Additional concomitant medications include vitamin B12 and Timolol Maleate 5% Eye Drops.  This patient received the second dose in the series and she had a little reaction. She started experiencing on and off sharp left elbow pain.  She stated her left elbow becomes paralyzed where she can't move it for 1/2 to 1 second and then it resolves.  She stated these events come and go.  She did not report these events to her healthcare provider.  She has not treated her elbow pain with any medications.  Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.