chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain with EKG changes and elevated troponin consistent with myocarditis. Onset 3 days after vaccine.
After sitting at the vaccination clinic for the required 15 minute, on the way  home I noticed my lips started to swell. Shortly thereafter my face started to swell. I asked my husband to take me to the emergency room, and it was noted in my charts that I had had an adverse reaction. I thought that was going to be the only symptom, but later on in the week I experienced vertigo, nausea, and my stomaching lurching. On Friday the week of my vaccination I noticed that my that my lips and face started to swell again, but went down shortly thereafter. My face and lips also started to swell today, but again went down. I told my husband is it happening because of stress or heat? I really do not understand why I am experiencing symptoms a week after my vaccine.
Fever  103.5 for 5 days; Twitching body movements while laying still day 6 and 7 post vaccine; Skin Mottling day 6, 7,and 8 post vaccine; Crossed Left Eye day 6, 7, 8 and 9 post vaccine; Unconsolable crying fits at night with arching of back from day 6 post vaccine and continuing; Poor nursing with arching of back and crying form day 6 post vaccine and continuing; Loss of balance day 6, 7, 8 and 9 post vaccine; Changes in emotion behavior and irritability from day 6 post vaccine and continuing.  All signs and symptoms as reported by the mother.
Arm where shot was administered was sore not long after injection. Started with headaches that got more severe over an hour at almost 11pm the same day, but never crippling. body aches, specifically in the ankles, knees, legs, butt, lower back, neck, fingers. Feeling very cold even when it's warm outside. The cold was to the point of having a very fitful sleep until being cold was realized as the problem. The aches and cold feeling persisted the next day; lesser in severity, but still tiring. This report is being filled in the evening of that second day.
pt complaint of itching at vaccine site to left upper arm,  lowered to floor as she became lightheaded,  911 called
body aches, vomiting, h/a, chills started 15MAY96;PE rx meds;
Swelling, pain, redness, irritation - Patient went to Urgent Care and was diagnosed with systemic cellulitis at injection site. MD treated with an injection of ROCEPHIN at the office, and gave patient a prescription for cephalexin 500mg, to be taken TID for 10 days to treat the infection, with instructions to return if the infection doesn't improve.
05/13/2000 W I c/o red, swollen and painful (L) arm day after receiving pneumonia shot. Ref to doctor after eval. Red, hot, tender 13 x 9 cm (L) tricep area.
Rash below injection, difficulty breathing. On 3/15, primary doctor prescribed prednisone 10 mg. 8 for 7 days. On 3/22 breathing better, but not the same as it was.
A report was received from a health professional on 10/29/02 and a follow up on 04/02/02. A second follow up was received on 05/21/02 concerning a 51 year old female patient, who experienced flu like symptoms the evening following a Fluvirin vaccine on 10/24/01. The patient had been vaccinated in the pas with no side effects. The hospital where she received the vaccine did not refrigerate the vaccine as recommended in the SPC, but stored it at room temperature instead. The patient recovered approximately a week after receiving the vaccination. There was insufficient information to determine the reporter's causality assessment.
On 2/3, 2 hours after vaccine, I experienced extreme heat to my face.  (The feeling I get when I?m going into anaphylaxis) but anaphylaxis never came.  It dissipated after a couple of minutes, but red face and ears all day.  On the 7th, I started noticing partial paralysis on the right hand side of my face.  It is still there.  I have not been around anyone outside of my home since March 2019 nor have those who live with me.  The  only exception has been when I got my two vaccine doses.
This spontaneous report was received from a office manager referring to a 10 week old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 26-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47°Fahrenheit to 77°F (61.7°F) for 2 hours 30 minutes and 32°F to 35°F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47°F to 77°F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007355: US-009507513-1808USA007354: US-009507513-1808USA007353: US-009507513-1808USA007351.
I've been in remission for ulcerative colitis for years. After taking the 1st dose, I had a flare up of the ulcerative colitis. And after the 2nd dose, I had another bad flare up that needed treatment. This has never happened to me in years. I've been taking Prednisone as treatment. I am still dealing with these flare ups.
Just had the shot, waited 20 minutes and left and then went to get groceries and started itching in my neck first and went down underneath my breasts, stomach, and arms around 3:30, 4:00 o'clock. Saturday evening burning and itching is really bad. Put some topical creams on it. Next day itching was less bad but I was sore and tender. Today the itching isn't as bad, but its hot to the touch.
Numbness around left eye, fingers and feet, felt dizzy and short of breath. Code called - given epinephrine, pepcid, benadryl, solumedrol and oxygen at site where reaction occurred (hospital cafeteria). Transferred to ED for further evalaution, monitored and discharged home.
c/o throat tightness after vaccination.  No SOB, rash, hives, headache, altered mental status.  pt. remain vocal and swallows water with no difficulty.  no PMH reported.   Allergy to bactrim and pollen.  Takes Zyrtec PRN.   Assessment WNL.  V/S   BP 134/72, P62, R 18, O2Sat 98%.  Pt. after few mins insisted throat is closing up.  Emergency personnel is called to the scene.  Epipen is given at 1:28pm.  Ambulance called with pt. transported at 1:39pm to hospital for further evaluation.   Patient not in distress prior to being transported.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. Same time last year, in 2013 the patient was vaccinated with ZOSTAVAX (dose and lot# not reported). In December 2013 the patient was diagnosed with the shingles, after received the therapy of ZOSTAVAX. The outcome of shingles was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Flu vaccine given 11/11/16 about 11am to 12pm. That evening patient got severe chills and uncontrolled shivering. About 45 minutes after going to bed in warm water be shivering stopped but felt he had a fever. Was fine next day.
Runny nose; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA for Parkinson's disease, CLONAZEPAM, GABAPENTIN, TAMSULOSIN and NORTRIPTYLINE HYDROCHLORIDE (PAMELOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 07-Mar-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, DIZZINESS (Dizzy) and RHINORRHOEA (Runny nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.   This case was linked to MOD-2021-036713 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of the events were updated.; Sender's Comments: 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.
57yr old patient with history of hypertension presented to PCP for follow up. Patient ordered flu vaccine and pneumococcal vaccine to be administered during visit on 10/25. CMA prepared and administered FLULAVAL QUAD 2018-2019 vaccine IM in patient's left deltoid and PNEUMOVAX-23 IM in patient's right deltoid ~1532. On 10/29, patient contacted nurse triage line stating left upper arm had itching and burning. Patient with no fevers, but some chills. Patient examined by MD later on 10/29 in office. MD noted mild redness in induration 2cmx2cm on left deltoid. Local skin/muscle reaction diagnosed.  patient educated and instructed to take OTC NSAIDS, warm compress and return in 1week if no improvement.
Initial misuse report received from a healthcare professional on 12 June 2013. It was reported that MENACTRA was administered to a patient over the age of 55. No more information regarding the patient. No adverse event was reported. Documents held by sender: none.
Fever began that night, and did not break until Friday.  Temperature was consistently in the 101.5-103 range,  temperature when well is significantly lower than normal,  so fevers rarely reach 100.  Nontrivial testicular and muscular pain.   These all occurred with  the second of the main shots (also Moderna),  as well as suspected Covid infection a year prior (with the lack of taste  lacking from the vaccine effects).  Primary concern is lasting neurological issues for the following week  that began with the onset of the vaccine. General cloudiness, light sensitivity, blurred vision, and severe balance issues occurred. This lasted until at least the Wednesday after (8 days from booster).   Seemed relevant to report in for data purposes related to severe TBI patients!
some mild symptoms similar to a common cold; This is a spontaneous report from non-contactable consumer (Nurse, patient, self-reported) via Pfizer Sales Representative. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 and lingering issues (with her sense of smell). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. After receiving her second dose of the vaccine, she felt some mild symptoms similar to a common cold for a few days on an unspecified date. After this, she said that she felt better than she had since she contracted COVID-19. For months she had lingering malaise that she said seemed to go away after the second vaccine dose, she said that she felt better than she had since before getting Covid-19 last summer. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected
First I began to notice generalized itching a few hours post vaccine, similar to allergic reactions I have had to insects. Then I began to notice mild finger swelling. Then swallowing became difficult, then I began to become nauseated.
Covid test result: Positive; Covid test result: Positive; Cold symptoms; stuffy nose; sore/scratchy throat; sore/scratchy throat; fatigue; aches; Chills; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 09Nov2021 12:00 (Lot number: EW0196) at the age of 52 years as dose 3 (booster), single, administered in arm right, administration date 29Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm right, administration date 01Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELECOXIB; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination. Tested for covid post vaccination. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 12:00, outcome "unknown", described as "Dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "Covid test result: Positive"; NASOPHARYNGITIS (non-serious) with onset 17Dec2021 19:00, outcome "recovering", described as "Cold symptoms"; NASAL CONGESTION (non-serious) with onset 17Dec2021 19:00, outcome "recovering", described as "stuffy nose"; OROPHARYNGEAL PAIN (non-serious), THROAT IRRITATION (non-serious) all with onset 17Dec2021 19:00, outcome "recovering" and all described as "sore/scratchy throat"; FATIGUE (non-serious) with onset 17Dec2021 19:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 17Dec2021 19:00, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 17Dec2021 19:00, outcome "recovering", described as "Chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. Therapeutic measures were not taken as a result of nasopharyngitis, nasal congestion, oropharyngeal pain, throat irritation, fatigue, pain, chills.  No follow-up attempts are possible. No further information is expected.
Patient complains of red, swollen, hot to touch arm. Advised to take Tylenol and use ice. Patient will call her doctor.
Child had a DTAP on 4/09/09. Benefits and risks explained - VIS info given. Mom noted fever at 11 PM 4-9/09, redness at site of injection noted in the morning. Size gradually increasing to present size.
Onset of adverse reaction started the same evening. Started with fussiness. Next day fever. By third day 104 fever, red and swollen thigh, and very warm to touch. Parent to give Motrin and observe. (Went to ER 12-18-09 and did follow up at the pediatrics 12-19-09. Parent to call with report on condition in 1-2 days.
Within 15-18 minutes after vaccine given, patient was c/o moderate itching of her throat. Lungs clear to ascultation bilaterally - no wheezing, no throat welling. BENADRYL 1 tsp given 1057AM with immediate relief of symptoms. No rashes.
Hot; Itchy; Red; Red welt at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Red welt at injection site), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Red welt at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE URTICARIA (Red welt at injection site), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient observed a red welt at injection site but then it went away. Then it suddenly came back, the welt was a one inch circle in diameter. It was hot red itchy and there was no discharge from it. The patient did not take any medications to treat the symptoms.
Three inch diameter red rash around the injection site, severe itching in the same area lasting three and a half days going  to mild symptoms on days 4 and 5.  Headache, fatigue, muscle aches lasting three days then only injection site symptoms and mild headache controlled with Tylenol and Aveno  hydrocortisone cream 1% applied 3 times daily on day 4 and 5 post vaccine. Rash around injection site minimal in appearance on day 5 itching minimized with Aveno  hydrocortisone cream 1% applied 3 times daily.
Right pupil dilating more sluggishly than left pupil. Symptoms: light-headedness. Duration of symptoms: 10 minutes. Provided hydration with improvement in symptoms. Went home with partner in stable condition.
I developed pre-ventricular contractions. I was feeling fluttering, and I checked my pulse and noticed long delays. I went to urgent care, and they saw it on an echocardiogram. I have to go for a Z-Patch next week and I have to wear a heart monitor starting October 14, 2022. They also prescribed verapamil and stopped to Topromil. The symptoms have improved. I do feel better with the medication, but I am not completely recovered.
I am on oral contraceptives and my period started in the middle of a pack two weeks after the end of my last period. I have been on the same birth control for 11 years and this has never happened. I did not miss a pill or take one late. I had extreme cramping within 24 hours of the first vaccine. The day after the cramping started, I had the heaviest period I've had since I began birth control 11 years ago.
Pain, swelling, numbness in arm, numbness in face, fever of 100.4, brain fog, muscle fatigue, exhaustion
Information has been received from a physician regarding a 3 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient received an unspecified dose of M-M-R II, subcutaneous for prophylaxis (anatomical location, lot number and expiration date were not reported). On an unknown date, the patient did not have the ability to tell when he had to urinate; the reporter felt that it qualified as transverse myelitis. The reporting physician stated that, on an unspecified date the patient had recovered from the myelitis transverse. The causal relationship between myelitis transverse and M-M-R II was not provided. Upon internal review, myelitis transverse was considered to be medically significant.
approx 24 hours after vaccine, he started with a rash on arms and above knee. It has spread to neck, chest, and face few hours after.
Missed the third dose of the vaccine; COVID-19; Mental anxiety; This spontaneous report was received from a consumer concerning her 19-year-old daughter with asthma, colitis microscopic and human papillomavirus (HPV) diagnosed on approximately 2008 (also reported at age 6). The patient's drug allergies included allergy to amoxicillin, penicillin and clindamycin. The patient did not take any concomitant therapy.  On 12-AUG-2021, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prevention against HPV (dose, strength, frequency, route of administration, anatomical location and lot number were not provided).   On 19-AUG-2021, the patient experienced mental anxiety.  On 15-OCT-2021, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prevention against HPV (dose, strength, frequency, route of administration, anatomical location and lot number were not provided). On 25-JAN-2022, she was diagnosed with COVID-19 (coronavirus disease 19); therefore, she missed the third dose of the vaccine that was programmed on 12-FEB-2022. The patient did not seek medical attention.  At the reporting time, the patient was recovering from mental anxiety and the outcome of the event COVID-19 was unknown. The reporter did not perform a causality assessment between the reported events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 1/29/09 with enterococcal prostatitis. Vaccination took place on 4/14/08. According to the physician the relationship is 'None'.  We would be happy to forward the Study's SAE reporting form upon request.  8/7/09 Clinical Research/Hospital records received DOS 2/25/09 to 2/27/09. Assessment: Urinary Tract Infection, bacteremia. Recent hospitalization for pneumonia, enterococcal prostatitis. Placed on antibiotics. Patient now presents with chills, hx of enterococcus bacteremia, maculopapular eruption secondary to drug reaction. Confluent rash more on ankles, wrists, and around neck resembling hives.  ICD-9 Codes: V13.02 history of disorders of the urinary system other, 601.0 acute prostatitis, 995.27 other drug allergy
Date of Admission: 2/2/2022   Chief Complaint: SOB   Source of Information: Patient   History of Present Illness:  This is a 81y.o. female with hx of chronic back pain (s/p vertebroplasty for compression fractures of T12-L4), bipolar I disorder, COPD (not on O2 at home), GERD, urinary incontinence, recurrent UTIs and HLD who presents to hospital on 2/2/22 with a chief complaint of SOB. Brought in by EMS from facility , where patient was found laying on her back with SpO2 ~70s, struggling to breathe and altered. Per caregiver, patient has not been sick recently.   Patient received Moderna Vaccine 6/2021, not boosted. Upon examination, patient in HHF 60L FiO2 95% -- tolerating well, SpO2 94%. Patient aware of positive COVID results, states she has not felt ill within the last 3 days, does admit to some decreased PO intake. Not on home O2, states she is able to ambulate around with assistance of a walker. Admits to feeling cold. Denies any current CP, palpitations, pain, SOB, N/V/D   Upon arrival to the ED:  o Vitals: T 98.3°F, BP 11/66, HR 137, RR 25, SpO2 81% on HHF w/ NRB. o Lab work obtained and remarkable for:  ? COVID + ? Troponin negative x3 ? Procal 0.50; D-Dimer 851 ? ABG 7.48/44/50/32 o Imaging demonstrates: ? CXR: Trace left effusion with subsegmental atelectasis in the left mid to lower lung zone ? CT Stroke + Cervical Spine w/o acute process  o Patient given 250 mL NS Bolus; Empiric abx with Levaquin + IV Flagyl  o ID has been consulted
Took on Friday, around 4 on Sat. started feeling bad, arm was hot & swollen, by 6 fever chills & hurt all over, by evening  numbness in both hands & feet , by 9pm headache started ? pain developed in chest, ribs & low back. Chills continued all nite as did pain all over  most especially numb hands/wrist  & feet.  Saturday upon waking fatigue but chills were gone. Feet were better ad was right hand. Continued throughout day  with shoulder, neck, rib,low back, knee  & arm  pain & fatique.