chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red spot on injection site; size of a dime and a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump). At the time of the report, VACCINATION SITE ERYTHEMA (red spot on injection site) and VACCINATION SITE MASS (size of a dime and a bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
blood blisters on the plams of my hands; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (blood blisters on the plams of my hands) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (blood blisters on the plams of my hands). At the time of the report, BLOOD BLISTER (blood blisters on the plams of my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications  were not reported  Treatment was not specified.  Patient started to get blood blisters on the palms of hands. Bloodwork and everything was normal.
Pt received moderna vaccine 4/7/21 and 5/5/21, and developed nausea and vomitting about four hours after the second shot.  These symptoms plus epigastric and RUQ pain and decreased po intake persisted until evaluation on 6/15/21 to medical center when pt was diagnosed with biventricular systolic congestive heart failure complicated by an RV thrombus and subsequent subsegmental LLL pulmonary embolus.  FYI - lot number above for 2nd covid shot is either 025B21A  or 025821A (the 4th digit is either a 'B'or '8').  shot #1 given at clinic and #2 given at clinic(both VA clinical areas)
Unrelenting gastrointestinal pain, loss of appetite, weight loss, nausea, and diarrhea since then. NO other medical history.
Area of IM IZ's (R) UE; red, warm, swollen. Gradually decreased pain with motion.
Initial report received from a healthcare professional (pharmacist) on 27 October 2014. A female patient of unspecified age had received a dose of FLUZONE HD, (batch number, dose number, route of site of vaccination not reported) on an unspecified date. The patient's illness at the time of vaccination was not reported. The patient was allergic to latex. On an unspecified date, after vaccination, the patient experienced flushing and reported felt like a "hot flash". The patient was monitored for several minutes and provided with glass of water. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Fever, chills, diarrhea and sever headache - lasted exactly 24 hours.
Severe Arm Pain Right Deltoid, Severe Headache, Very Sore Eyes, Confusion, Weakness. Rapid Heartbeat.
Patient described injection site redness, swelling. soreness and rash across his back and torso.
Information has been received from a nurse referring to a 12 month old female patient. Patient's concurrent conditions, concomitant medication and medical history were not provided. On 29-MAY-2015 the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (lot# was reported as L005295, expiry date 17-AUG-2016) and a dose of VARIVAX (Merck) (lot# was reported as L001327, expiry date 13-JAN-2017) (dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
On 12-7-10 child was sent home from school with rash on face, arms, legs. T=98.7. Seen by pediatrician who diagnosed rash as non specific skin eruption/urticaria. MD suspects reaction to FLUZONE.
pt recvd vax & devel submandibular gland swelling; No further details were provided;
Right anterior thigh with 6" x 7" area of swollen, red, hot tissue that was tender to touch.
Severe allergic reaction Suffocating and not being able to swallow  Had to go to emergency room Injected with steroid anti inflammatory, Benadryl and pepsid
URI symptoms off/on 1-2 weeks, daughter tested positive on 10/27/21
No adverse event; two patients received expired MMR II vaccine; two patients received expired MMR II vaccine when they were supposed to receive a dose of PROQUAD; This spontaneous report was received from a registered nurse referring to an unknown age and gender patient.  The patient's concurrent conditions, medical history, drug reaction or allergies and concomitant therapies were not provided.  On 20-JUL-2023, the patient was administered 1 dose of expired vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) (albumin status rHA) injection, 1 dose, (lot number U022316 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported and established as 15-JUL-2023) (strength, and route of administration were not provided), this vaccine was administered instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). No adverse event was reported.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2307USA011531:
patient has not experienced any additional side effects; they made a mistake and accidentally gave a dose of hepA to a 4-day old.; This spontaneous report has been received from a medical assistant via a company representative, referring to a patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      The reporter stated that on 22-OCT-2020, they made a mistake and accidentally gave a dose of hepatitis a vaccine, inactivated (VAQTA) (lot #, expiration date, route and dose details were unknown) to this patient prophylaxis (product administered to patient of inappropriate age). The patient had not experienced any additional side effects. The reporter wanted to know all the steps they need to take and if the child would be ok to get vaccinated with hepatitis b vaccine in a week.
This spontaneous report has been received from a pharmacist via a company employee referring to a 16 years old female patient. Information about concomitant medication, concurrent condition, and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (strength, dose number, frequency, batch/lot #, and expiration date were not reported). It was unknown which shot in the GARDASIL 9 series that was being administered. On the same day, the patient experienced syncope (reported as "syncopy"). The patient sought medical attention in doctor's office at the time of the event. The patient stayed longer than required 15 minutes and required juice at doctor's office. Treatment was given for the event. No lab diagnostics were performed. It was also reported that the therapy was continued. At the time of the report, the outcome of syncope was reported as recovered. The causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA008576.
Pt recvd measles vax on 14FEB90 & became pregnant (LMP 07MAR90); pt devel proteinuria & pedal edema during last trimester of pregnancy; due to indications of cephalopelvic disproportion, failure to progress, & prolonged labor (49 hrs);
Redness and swelling below the site with warmness to the touch.  Per PCP was given acetaminophen and benadryl with improvement.
Patient had Moderna vaccination on 1/28/2021 and felt well that day and previous days. She woke up the next morning with altered mental status. low grade fever and confusion that improved within a few hours but did not resolve for at least 24 hours. She went to the Emergency Room at Hospital on 1/28/2021 and had labs, urine  and CT of head that were all normal/no acute abnormality. Her symptoms resolved at about 24 hours or so and she has been well since. She was released from ER, not admitted.
Patient did not receive the entirety of the second dose. Had some of the vaccine "run down his arm". Patient is scheduled to receive the full second dose on 1/19/2021.
The patient received the Pfizer Bivalent booster that is authorized for those 12 and older, and the patient is 10.
A few hours after injection there was a sense of extreme lethargy through my body. I got to experience fevers, migraines, cold limbs, shivers, nausea. I felt that my body/emotions went into panic. I had SARS-CoV-2 virus in December and it was no where close to how bad this vaccine made me feel.
Syncope following vaccinations, then labwork (Had vaccines, then labs, then syncope occurred - Nothing to eat today).
Noticed numbness in left little finger (not same side as shot was given) first, then crept into palm. Also, in horizontal side of ring finger (left side palm facing down) from tip to base and in top joint of ring finger.
My arm stated tingling within 15 minutes & an hour later my arm swelled up to my wrist, becoming red and hot to touch. Also, I had extreme pain in my shoulder and elbow. I decided to sit down on the couch and take it easy because I felt fluish. My temp rose to 100.5 & my head was pounding. I took a Naprosyn & ate some soup, still felt ill. When I woke the next day my fever was gone & so was my headache, but my arm was still swollen, red, hot to touch and I was unable to lift my arm. the swelling went down after about 72 hours. I was unable to lift my arm over my head until 5 days later. Never in my life had I ever had a reaction to a vaccines, medications, or food.
The morning of 11/17/2021, the day after vaccine, I had a light headache and abdominal cramping. The cramping kind of progressed. The period started abnormal and throughout the day it became excessively heavy. I had to use multiple sanitary pads throughout the day. I do have fibroids, and I read, if you have fibroids the vaccine can make your menstrual heavy. I bled all over my brand-new car seats and I had excessive bleeding all over my bed sheet. The puddle was like a 1-foot puddle on my side the following morning. I did not go to work the next day because I was constantly changing. I had a headache for a total of 4 days, and I tried to take everything I can before I take Imitrex. I finally had to take Imitrex and slept the following day and my headache was finally gone. Today, 11/22/2021 I finally woke up with no headache. I contacted my clinic and had a telephone conference regarding my symptoms. They told me to stay home because it was a side effect of the vaccine.
The day of vaccine, I felt a little tired. The next morning, I ended up have a lethargy reaction (9:00 am) - it was like I was a robot and I hd powered down. I couldn't sleep but I was sitting up and thought I was sleeping. I couldn't really talk. My co-workers were very concerned. Lasted a couple hours and I went home and I went to sleep and slept about 16 hours . I called off work the third day - I had slept so  much after that night before I had a  (first) gall bladder attack (in the middle of that 16 hours) it was very bad (the gall bladder attack). I had gall bladder attacks occur for the next few days. I ended up getting my gall bladder out last Friday - about a week ago. It was inflamed and full of pus. It was an emergent situation and I was hospitalized 18th and surgery on the February 19th. Lethargy eventually subsided (lasted a handful of hours)  and was then fatigued with no energy for about a week .
starting at 930 pm the day of vaccination I started to have SOB and chest pain. I tried to take 2 puffs of my ProAir inhaler, this did nothing to help the SOB. Within the hour I could not get a full breath at all. the chest pain was only tolerable if I was leaning forward. My husband took me to the ER. They did testing and found that I had Pericarditis and Pleuritis. They informed me that I should NOT get any further COVID vaccines because it could kill me.
One day after recieving the DTaP vaccination the patient experienced 5-6 inches of swelling, reddness and tenderness on the left leg. The leg almost doubled in size for 4-5 days.
Blood Clots both lungs, Hospital stay x4 days, shortness of breathe, heparin IV x3 days and oral blood thinner x6 months
BODY ACHES; FATIGUE; FEVERISH; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Q02A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced body aches, fatigue, and feverish. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fatigue, feverish and body aches was not reported. This report was non-serious.
Intermittent chills; headache; mild muscle aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 3247 and expiration date was not reported), via an unspecified route of administration, administered in arm left on 25Feb2021 10:00 am (at the age of 47-year) as dose 2, single for covid-19 immunization. Patient had no known allergies and relevant medical history includes Crohn's disease. The patient concomitant medications includes vitamin B12, vitamin D and probiotics received 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 3247 and expiration date was not reported), as first dose, on 04Feb2021 10.00 am for covid-19 immunization. Reported on behalf of herself- received the dose on 25Feb2021 and started experiencing symptoms that same evening on 25Feb2021. The patient experience intermittent chills, headache and mild muscle aches on 25Feb2021, 11:00 PM. The events were considered as non-Serious. The patient received acetaminophen treatment for adverse event. The outcome of the events was recovered on an unspecified date in 2021.    No follow-up attempts are needed. No further information is expected.
I received my 2nd Moderna COVID-19 Vaccine EUA on 2/24/2021. Had only a mild sore arm. When I woke the next morning I was fine with still just a mild sore arm. Then 21 hours after my vaccine I started getting chills and fever 101.9 which I read I could have after the vaccine. The unusual thing that occurred was how cold my hands got, they became so cold they hurt. I had a difficult time warming them up when I checked my oxygen level it was low, 89. I assume because they were so cold. This was very uncomfortable. I have never experienced this freezing hands before, and I have not seen it has a symptom so I wanted to inform someone. I started taking Tylenol with my fever and it broke overnight and I feel fine now.
230PM same day-pt had t102;not responsive to APAP on 26JUN96;pt had temp of 103;some muscle jerking noted;improved by 27JUN96;no further muscle jerking-temp nl;
The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my body all through the night. This morning on 1/20/21 I had a horrible migraine that lasted till 3:30pm. All the symptoms went away by 4:30pm
Information has been received from a registered nurse concerning a 11 year old female with drug hypersensitivity to codeine, who on 02-AUG-2007 was vaccinated IM in the left deltoid with a second dose of Gardasil.  On 02-AUG-2007 in the late evening, the patient experienced headache, dizziness, nausea and loose stool.  The symptoms lasted 24 hours. On 04-AUG-2007, the patient recovered.  Additional information is not available.
7 month-old child received only DTaP/ IPV portion of vaccine/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7-month-old patient who received only DTaP/ IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient had received DTaP (Diphtheria, Tetanus, Ac Pertussis), Hep B (hepatitis B), IPV (inactivated polio vaccine) and Act HIB in past. Past medical history, medical treatment and family history were not provided.  Patient received HEPATITIS B and PNEUMO as concomitant medication.   On 20-Mar-2020, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [DTaP/IPV: lot UJ315AA, expiry date: 04-Apr-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that, Patient did not receive the Act HIB [lot UJ258AA, expiry date: 04-Apr-2021] portion of vaccine.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Fever escalated over the course of the evening to 104 degrees Fahrenheit underarm, she vomited several times and I gave her infant Tylenol. Fever lasted days.
Injected arm getting more sore with time, tinnitus, dizziness, nausea, weakness, trouble sleeping, headache, joint pain in neck, arms and shoulders, loss of appetite.  I'm on day 3 of symptoms
I have headache like migraine headache on the side, off and on like every four hour every three or four hour; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced fever on 25Dec2020. The patient also had a headache like migraine headache on the side, off and on like every four hour every three or four hour on an unspecified date. Clinical outcome of fever was recovered on Dec2020, while for migraine headache was unknown.  Follow-up attempts are not possible. No further information is expected.
This spontaneous report as received from a neurologist via Pfizer refers to a currently 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies which included fever (pyrexia), chills, headache, site pain(vaccination site pain), joint pain (arthralgia), weakness (asthenia) and  exhaustion (fatigue). The outcome and causality assessment were not provided by the reporter.
Approx 6PM, mom noticed lt leg, warm to touch & reddness; knee sl swelling, temp 101R, irritable, exp discomfort when touched on leg & knee; Lt knee measures 22 3/4cm-rt 21 1/2CM; Vax given 1 day ago;
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 02/18/2021 and 03/10/2021. They tested positive for COVID-19 via PCR test on 10/08/2021. They presented to emergency department on 10/16/2021 with primary complaint of shortness of breath. They were admitted to hospital on 10/16/2021. They experienced complications of COVID-19 pneumonia, an acute kidney injury, and hypoxic respiratory failure.  They remained hospitalized until their death on 10/24/2021.
Patient is fully vaccinated and boosted.  COVID positive on 5/6/2022 at admision to hospital.90-year-old female who presented to the hospital for evaluation of hyponatremia/difficulty swallowing.According to her daughter, in December she was diagnosed with pneumonia for which she initially presented to the urgent care, was prescribed Levaquin and prednisone however she became much worse therefore she presented to a local Hospital, she was diagnosed with new onset myocarditis and atrial fibrillation and new onset congestive heart failure with low ejection fraction,dx: acute hypoxic respiratory failure.  Chest X ray with pleural effusion.  Medications: oxygen, decadron, antibiotics. WBC 31.8, elevated inflammatory markers. Thrombocytopenia. + hyponatremia. Pt transferred to Beaumont in house rehab from 5/17 to 6/4. Discharged
From initial information received on 6/23/05 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a three month old male patient received his second dose of DAPTACEL, lot number not reported, administered on 2/23/05. The route and site of administration were not reported. An unspecified amount of time later, the patient was diagnosed with sensory problems. Per the patient's mother, the child did not recover from this event. The patient previously received his first dose of DAPTACEL, lot number C21DBAA (not a valid lot number) as well as a dose of IPOL, lot number X1240-2, a dose of COMVAX, lot number 0807P, and a dose of PREVNAR, lot number A67184F, administered on 1/4/05 and three to four hours later developed persistent crying and arching of the back. This information has been captured in case 200501214. (OMIC)
ACHY BONES; SICK WITH FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced achy bones, and sick with fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy bones and sick with fever was not reported. This report was non-serious.
Pt admitted to hosp 22DEC67 w/convuls of 6 hrs duration, one day after vac.  Reporter told child should not receive more "P".  Child has some degree of retardation.  Mom wonders of d/t DTP.  See WORM for more info.