chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unspecified date in August 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). No co-suspect or concomitant therapies were reported. On an unspecified date in December 2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not provided). The nurse reported that the patient had not received the 3rd dose in the GARDASIL series. No adverse effect reported. Additional information has been requested.
7/14/headache, vomiting, swelling of left arm, left arm. side, breast started to swell. Unable to lift left side. Left breast 4 cups bigger, diarrhea, fatigue, no appwtite
Narrative:  Pt was a 76yr male died Wednesday, July 28, 2021 at hospital. PMH includes Aortic valve replacement, pacemaker placement, CHF, Atrial Fibrillation, Obstructive Sleep Apnea, COPD - never smoked, agent orange exposure, Depression, HLD, HTN, BPH s/p TURP, Chronic pain syndrome, Degenerative disc disease in the spine L4-5 fusion, Osteoarthrosis, s/p hip replacement, Trigeminal neuralgia, Osteoporosis. Vaccines are likely not related to death.
Headache, Sedation, Myalgia, Fever, NauseaVomiting,  chills, fatigue and swollen glands. pain at injection site
pt received a second pfizer bivalent immunization when one was not needed, pt experienced mild flu-like symptoms
Patient had a seizure within a few minutes of receiving these vaccines. He was on his way to a bench to take a seat and collapsed against his partner. A pharmacy technician helped to clear the scene, paramedics were called, but the patient regained conciousness quickly and did not need further treatment.
Difuse red papule rash and itching face,upper and lower body. I took the vaccine 2/24/09, but since then as a RN I have administered at least 30-40 injections and developed a rash that has been getting progressivly worse, and now after administering the last injection on 6/17/09 my face and upper body, especially my face, neck and upper chest is covered.
Arm was sore day after vaccine, but on the 3rd day her arm "swelled up" around vaccine site. 2" x 5" swollen/red area - "hurts a little". Informed pt to tell PCP about reaction, to ice and take NSAID if painful & swollen.
Patient was given vaccine that expired on 12/2/22 on 12/14/22 at 11:44 am. Patient did not have a reaction to the vaccine while being monitored in the office for 15 minutes.
Red, itchy arm, burning pain in elbow, headache, muscle aches, fatigue.  Arm and elbow pain continue still, headache lasted 36 hours, the rest resolved in 24 hours.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt rec'd booster dose on 10/24/2021. Pt called into pharmacy on 10/25/2021 approx 11am complaining of large red, swollen, slightly hardened area extending from shoulder blade over the shoulder and down the arm all the way to the wrist (on the side on which the vaccine was given).  Pt denied fever/chills.  I advised pt to watch and wait, but also have primary care phycisain evaluate ( she has appt scheduled for 10/26/21.
Case previously recorded as MA2009-6268. Initial case report received from a heath care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Patient seen day after vaccine with redness, swelling, streaking near injection site. Will be seen again to reevaluate. Started on antibiotics for cellulitis.
Welt around 2.5 inches long and 1 inch wide with white coloration. Very sensitive to touch and causing quick jabbing pains at random times.
Pharmacist did not dilute the vaccine before administration. Patient received 0.3ml of undiluted vaccine.
PATIENT WAS ADMINISTERED MMRV BUT IT IS ONLY LICENSED THROUGH AGE 12.
covid test result Positive; covid test result Positive; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: EL3248) at the age of 30 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 19May2022, outcome "unknown" and all described as "Break through infection based on lateral flow assay aka Rapid Covid Test with fever, achiness, chills, and a sore throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, chills, oropharyngeal pain.
suddenly passed out; doctors thought this indicated some injury to the heart; elevated troponin levels; abnormalities in EKG; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Lot number: FJ8726) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 24Nov2021. Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0172), administration date: 23Apr2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: FJ8726), administration date: 01Apr2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization) with onset 11Feb2022, outcome "unknown", described as "suddenly passed out"; TROPONIN INCREASED (hospitalization) with onset 11Feb2022, outcome "unknown", described as "elevated troponin levels"; ELECTROCARDIOGRAM ABNORMAL (hospitalization) with onset 11Feb2022, outcome "unknown", described as "abnormalities in EKG"; MYOCARDIAL INJURY (hospitalization) with onset 11Feb2022, outcome "unknown", described as "doctors thought this indicated some injury to the heart". The patient was hospitalized for loss of consciousness, troponin increased, electrocardiogram abnormal, myocarditis, myocardial injury, cardiac disorder (hospitalization duration: 7 day(s)). The events "suddenly passed out", "elevated troponin levels", "abnormalities in ekg" and "doctors thought this indicated some injury to the heart" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (2020) no abnormalities, notes: from 2020 and before; (11Feb2022) abnormalities; inflammatory marker test: (unspecified date) inflammatory markers in blood were normal; sars-cov-2 test: (11Feb2022) negative, notes: Nasal Swab; (11Mar2022) negative, notes: Nasal Swab; troponin: (11Feb2022) elevated. It was unknown if therapeutic measures were taken as a result of the reported events. Clinical course: The patient doesn't know if this was related to the vaccine, but he suddenly passed out and was hospitalized. The main notable findings in the hospital were elevated troponin levels and abnormalities in the EKG that were not present in the EKGs from 2020 and before. The doctors thought this indicated some injury to the heart, but they do not yet know what happened to the heart or why. The doctors did not think it was myocarditis related to vaccine both because the vaccine was several months before the hospitalization and because the inflammatory markers in the blood were normal. However, because the cause of the heart issue was still unknown, the patient thought he'd report it in case any others had something similar happen. No Covid prior vaccine.  No follow-up attempts are possible. No further information is expected.
Fever around 102; Chills; Body aches; The worst headache of my life; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life). At the time of the report, PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever around 102.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient had fever around 102, chills, body aches, and the worst headache of life. Patient had the same symptoms after every vaccine and every booster. Patient had 2 vaccines and 2 boosters. It was always started the night that had the vaccine.  It was unknown if the patient experienced any additional symptoms/events.  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-721304 (Patient Link).
About 12 hours following the vaccine, I suddenly felt like I had the flu - shivers, shakes, nausea, headache, fatigue but no fever. I went to bed and woke up the next morning and felt back to normal. I was fatigued the second day and had a very sore arm.
Tinnitus; hearing loss in bilateral ears; This spontaneous report was received from a physician refers to a 71-year-old female patient.  The patient's concurrent condition was not reported. The patient's medical history included tinnitus (reported as: tinitis lowe grade). The patient's concomitant therapies included colecalciferol (VITAMINE D).  On 27-APR-2023, the patient was vaccinated with the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter, intramuscular (lot #, expiration date, and anatomical location were not reported) for prophylaxis.   On 28-APR-2023 the patient experienced tinnitus and deafness bilateral. The outcome of tinnitus and deafness bilateral was reported as recovering/resolving.  The causality assessment was not provided.  The significant disability was stated for the events of: tinnitus and deafness bilateral by physician due to the patient's loss of hearing.  The event of deafness bilateral was considered to be medically significant.
Approximately 2 hours after receiving PNEMOVAX 23 she began having severe HA, abdominal pain, fever = 39C, diarrhea and severe dizziness. Called 5 hrs after receiving vaccine with above symptoms; sent to ED.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Liothyronine, omeprazole and REGLAN. On 17th January 2018 11:00, the patient received SHINGRIX 50 mcg/mg. On 17th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. In January 2018, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient experienced redness and soreness at the injection site and red circle approximately one inch in diameter and spread to one and half inches after a day or two. The symptoms were resolved after 4 days. Treatment was provided by the pharmacy.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and developed at the injection site a hot, red, swollen painful area that lasted for about 4 to 5 days and completely resolved. The batch number was not provided.
This spontaneous report was received from a nurse via company representative regarding a 13 year old female patient. Information on the concurrent conditions and medical history were not reported. On 15-OCT-2013, 17-DEC-2013 and 22-OCT-2014, the patient was vaccinated with dose 1, 2 and 3 of GARDASIL (lot, expiry date, dose, frequency, route and anatomical location were not specified) 1 dosage form respectively. On 03-JUN-2016, the patient was inadvertently administered a dose of GARDASIL 9 (lot# L043213, expiry date 28-AUG-2017) intramuscularly 1 dosage form. Concomitant medication were not reported. No adverse event was reported. There were no Product Quality Complaint (PQC) involved. Additional information has been requested.
1/3/91 c/o red bumps on stomach arms x 2 days. Treated w/Benadryl & Tylenol.
mom called 30JUL97 to report child had broken out in rash  over entire body & had swollen lt arm w/large area of redness;spot was hot & itchy;no prev problem w/vax;lt arm sore to touch;referred to MD;arm still red & sore;
Uncontrollable shivering/shaking approximately 12 hours after receiving the vaccine.  Went to bed to get warm and slept reasonably well.  Had slight head ache in morning but but felt 100% again by lunchtime.  Didn't take anything for the headache.  Temperature was 1F above normal when I woke up.
I had a sore throat for 2 days. Followed by not a particularly bad cough for 2 days. No fever, no shortness of breath as measured by a pulse oximeter. I took night-time cold medication and it helped me sleep. I used throat lozenges and some chicken soup.
UrticariaPruritus, NauseaVomiting, pain and swelling at injection site
Got the a shot om the 27th in the afternoon. That evening around 6-7pm i grew pretty nauseous. I usually have some so didnt think much on it. I woke up at 2-3 am with extreme nausea, sweating, headache, vision spinning and shaking. I did not have this the first round. I waited for it to go away but by 6-7 am it hadnt and i was feeling terrible. I took some zofran amd after an hour nothing changed. I ended up taking one and hiur later and another am hour after that amd eventually fell asleep. I woke up around 1pm soaking wet with sweat again but no longer shaking or nausea. The injection site did itch the first few day and swell up a good bit that following week with a ring around the reddest part inside and about the size of 2.5 in in diameter. The redness went down and turned into a more purple bkack colour like a bruise of the 1st one. The only reaction on the first was swelling, red, itchy for a couple of days amd the skin "died"? Like it peeled layer like a sunburn where the spot was.
Extreme fatigue continued weeks after vaccination when other symptoms (fever, chills, etc) that abated.
Patient was experiencing swelling and itching in her arm at the injection site. After two days, the mom note there has not been improvement, but it has not worsened. The mom has been giving the daughter diphenhydramine at night and the patient has been using an ice pack on the injection to help with the itching. I instructed the patient's mother to call the patient's primary care provider today to make them aware and make sure they did not have any other concerns or recommendations for treatment.
Developed a red rash in left arm at injection site that moved down his arm; Developed a itchy rash in left arm at injection site that moved down his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm). At the time of the report, VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm) outcome was unknown.            Concomitant medications were not provided. Treatment information include steroid cream  twice a day   This case was linked to MOD-2021-350964 (Patient Link).
(February 2013 received Varivax series).  Several days after Shingrix vaccination arm swelled and was painful. A large raised red rash, warm to the touch, appeared, with a tingling itchy sensation. As time is going by tingling sensation is lessing, rash is fading and less raised, is still warm to the touch.
Irreglar heart rate which led to emergency room visit with end diagnosis of atrial fibrillation and patient needing to start eliquis
Large red "patch" beneath the injection site. Approximately a week later, the patch turned into a red, itchy rash.
Day 1 headache nausea, body aches. Day 5 very swollen Lymph nodes under right arm (Injection site arm)
Between 4-5pm I began developing flu-like symptoms (body aches, headache, chills, joint pain, fever). But around 10pm I began to feel nauseous. It kept getting worse throughout the night. Around 6am I used the restroom, and after I go up to wash my hands, I felt a wave of nausea. I was trying to decide whether to vomit in the sink or the toilet, when the next thing I recall I was on the ground, unable to open my eyes or move or speak at first. My husband said he head a big thud, then didn?t hear anything for about a minute, so he came to check on me. I had passed out and fallen, from standing to the floor. My head bashed a hole in the wall right above the floor. I was scraped and bruised on my cheek on one side and my brow on the other. It seemed that my head also hit by/ricocheted off of a couple hard objects near the wall.  I couldn?t move for 10 mins or so, then when I could it gave me too much nausea and vertigo and I had to lay still again. After 20 mins I could crawl. I saw the first provider open. I felt like I?d been hit by a truck. Physical pain, neck pain, and headache. The dr. did a neurological exam and told me to take ibuprofen and stay hydrated. The ibuprofen helped a lot.
Pain in chest.  Couldn't sleep.  Went to ER 5/2/2021 Amitted to hospital for 3 days CT with and without contrast.   Vascular Surgeon said very rare, no other systems.  Referred me to Rheumatologist; he ran a large amount to test;  for vasculitis, hepititus, and other  - just received results, all were non-remarkable....no markers.
Shivering, upset stomach, tiredness, muscle ache, pain and swelling at injection site. Shortness of breathe. Within 12 hrs (2 pm) most symptoms were greatly diminished.
I experienced a breakthrough case of COVID-19, burning in my nose, cough, fever, shortness of breath, headaches, fatigue, weakness, loss of taste, loss of smell, symptoms lasted for 9 days.
pt has swelling of injection site, bumps, redness, and itch. started after the vaccine and has been this way for 5 days since.
Red itchy rash beginning 4 hours after above injection site Left arm, left side of neck,upper chest  PO Benadryl 25 mg. Less itchy but redness the same
Large itchy rash developed on the right leg at both injection sites. The rash spread over four days before eventually fading away. We were instructed to give her Benadryl  and ice the areas (to reduce itching and swelling)
Upon leaving the store, started to develop headache. Next morning, headache severe, neck pain, nauseated and very tired. Headache lessened by 2nd day, still very tired, neck pain and nauseated. Neck pain persists, very tired and still some nausea.  Eating very little due to feeling of getting sick.
approximately 10 minutes after administration of Varivax pt complained of not feeling well. Looked sweaty and started coughing and vomiting. Albuterol nebulizer treatment was started. Pt stopped vomiting but became pale/lethargic with a flushed rash. Epinephrine (1:1000)IM and Benadryl IM was given with improved color/pt more alert. Pt was transported to ER for further care/ observation.
Nausea, vomiting, diarrhea, fever. Mom states she had same reaction after first dose Hep  A.
Information has been received from a consumer concerning his friend, a 73 year old male with a "deteriorating heart" and no known allergies who on 23-JUL-2007 at "about 07:30" was vaccinated once SC with a 0.65 mL dose of Zostavax. Concomitant therapy included COUMADIN and oxygen (started "a few days before this happened"). Two hours after vaccination the patient "died from a heart attack when his aorta ruptured." It was reported that the patient was revived with CPR but when the patient got to the hospital the doctor stated that he had "died instantly." There was no product quality complaint involved. No further information was provided. Additional information has been requested. The reporter considered the patient's to be serious as other important medical events. The patient's events were also considered serious for death.