chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA    Within minutes of receiving vaccine, I developed itchiness at injection site. Within 5 minutes, developed itchy lips and scalp, and my asthma cough. No rash or shortness of breath. Went home after the 15 minute waiting/observation period. Developed nasal congestion when arrived home (5 min). Took 25 mg benadryl and my albuterol inhaler. All symptoms resolved in 90 minutes.
Patient received inappropriate brand for third dose of vaccine. Patient provided written consent to receiving this brand of vaccine. Patient left the vaccine clinic after 15 minutes without any signs of distress.
ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Blackout/seizure (minor car accidents), fatigue to the extent of sleeping 12-14 hours.
Shingles vaccine injected Monday 11/23/07. On Saturday 11/26 My hands up to the elbow and both ankles developed extreme redness and some burning and itching. The rash then developed on the back. I used hydrocortisone cream for the itching and the burning. Today 12/6/07 I still have rash but itching has sub-sided. Started with rash on upper hand from finger to wrist then it went to both ankles down to toes. Also on back doctor recommended Benedryl which I took it 4-6 hours. Rash dissappeared in about about a week.
vaccine administered after temperature excursion; No additional AEs or PQC reported; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 27-JAN-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1821811, expiration date: 27-JUL-2022, 2 ml, orally for prophylaxis (incorrect product storage).  The vaccine experienced temperature excursion of 35 degree of Fahrenheit for 1 hour and 24 minutes. The previous temperature excursion was not detected. No additional adverse event was provided.
The products expiration was 09/30 per lot number but the actual expiration is 10/19/22. Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received patients received improperly stored doses of VAQTA, lot # L007559, expiration date 01-JUN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
I received an injection in June and July 2020 to control my herniated discs problems that caused me severe sciatic pain down my left leg.  After those injections I have led a normal life.  NO issues whatsoever.  No discomfort, no leg pain, no back pain.  Within about an hour after receiving the COVID-19 injection, I started to have discomfort and pain in my lower back.  Within a few days my sciatic pain had returned.  I am now scheduled for another injection in my back for 4-23-21 to get rid of the sciatic pain.
Small red area approx size of a nickel with small blisters. Swollen lymph at groin blister appeared on R leg 9/21 still there.
Pt admitted to hospital with COVID on 11/6/21 s/p 1 dose of J&J vaccine on 4/7/21.
26 year old received pediatric dose; 26 year old received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 26-year-old male patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 3rd June 2022, the patient received Engerix B pediatric. On 3rd June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: Medical assistant reporting that an adult patient received a pediatric dose of Engerix-B. Adverse event contains all health care professional (HCP) reported information. Health care professional (HCP) gave consent for safety to follow up.  Health care professional (HCP) did not wish to provide an email nor postal address. The reporter consented to follow up. Additional Supportive: the adult patient received received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Information has been received from a pharmacist concerning a 31 year old male with a history of pneumonia and bacterial infection who on 02-NOV-2006 was vaccinated with Pneumovax 23 (Lot # 651401/0619F). On 04-NOV-2006 the patient experienced nausea, vomiting, swelling at injection site that went up his arm. The patient was seen in the Emergency Room (ER) and given antibiotics, but was not admitted. At the time of the report, it was not reported if the patient recovered. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Induration at injection site.  Erythema and warm to touch.  Painful, affecting RoM of left arm.  Pt marked to monitor growth, put quarters 24h.
6/27/07 Adacel given IM. 6/28 Chills, fever 101 x 24x36 hours.
Epigastric pain, nausea, vomiting, weakness, dizziness - 4 hrs after shot given.
Headache, & mild fever for a couple of days. Then lethargic, dizzy and brain fog.
Started having fever 5/9/12 (106). Seen at ER was told secondary to OM. Given AMOXIL - still had fevers - rash started 5/12/12 - seen in office here 5/21/12 - rash papular no vesicles. No fever after rash. Rubeola IGM - positive.
second shot: hole in retina of her eye (right eye); Had numbness in her toes; second shot: Blurred vision (distorted) right eye; second shot: tendonitis (constant ringing in the ears); autoimmune levels were up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 13:30 as dose 2, single (Lot number: EN6198) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch lot no: EM9809), administration date: 04Feb2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Jul2021, outcome "unknown", described as "autoimmune levels were up"; RETINAL TEAR (medically significant), outcome "not recovered", described as "second shot: hole in retina of her eye (right eye)"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Had numbness in her toes"; VISION BLURRED (non-serious), outcome "not recovered", described as "second shot: Blurred vision (distorted) right eye"; TENDONITIS (non-serious), outcome "not recovered", described as "second shot: tendonitis (constant ringing in the ears)". The event "second shot: tendonitis (constant ringing in the ears)" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: autoimmune levels up, notes: autoimmune levels were up. Is what the blood work showed. Therapeutic measures were not taken as a result of autoimmune disorder, hypoaesthesia, tendonitis.  Clinical Course: Reporter wanted to know where to go to report an injury from the Pfizer Covid 19 vaccine. Had numbness in her toes, hole in the retina of her eye and tendonitis (constant ringing in the ears). Wanted to go on record that she reported it and what happened to her. Event details: Two months after had the Pfizer Covid 19 vaccine everything started. Later clarified that about 5 weeks after she had the second shot that she had ringing in her ears. Later clarified that it was 4-5 weeks after the second shot that she had ringing in her ears. Few weeks after that she started having numbness in her toes and blurred vision in her right eye. Later clarified as numbness in toes of both feet but more in the right foot: no treatment. hole in retina of her eye. Was told they wanted to put a ball in her right eye. Took pictures of her eye and saw the hole in her retina. Had pictures within the last 30 days. tendonitis (constant ringing in the ears): Made an ear doctor appointment. No treatment. autoimmune levels were up: no treatment Product details: Had the second Pfizer Covid 19 vaccine at 1330. Had the first Pfizer Covid 19 vaccine on 04Feb2021 with lot number of EM9809. Investigations: Went to the doctor when she started having problems and was told that her autoimmune levels were up. Is what the blood work showed.
Vomiting profusely, dizzy to the point of not being able to stand, extreme sensitivity to light and noise.
Right after my shot, my arm started throbbing.  I layed down and slept for 4 hours which is unusal.  When I awoke, my arm was still throbbing.  Red, achey, swollen, knotty, and unable to use my arm were the worst symptoms. The red rash went up my arm to my shoulder.    I used an ice pack to help with the swelling and the ache.  This went on for 5 days after my shot.   Today is the 14th of January, almost 20 days after my shot, and I still have shooting pains going down my arm.  I am unable to pick anything up if it has any weight to it (over 2 lbs).
This is a serious spontaneous case, initially received on 06-Mar-2018, from a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (prefilled syringe, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, expiry date: 31-Mar-2018, dose: not reported). On 05-Mar-2018, patient experienced sore throat and low grade fever but there was no body ache. The patient thought it was a sinus infection. However, on 06-Mar-2018, after 5 months 8 days of vaccination, the patient was diagnosed with type A influenza (positive) (considered as vaccination failure). She took TAMIFLU. It was reported that, the patient felt well (recovering) at the time of this report and would go to work from 11-Mar-2018.
Extreme pain could not sleep, could not move arm on second day, ran a 100.1 fever, arm was extremely red and hot to the touch three days now.
gotten COVID-19; gotten COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 51-year-old male patient received BNT162b2 (COMIRNATY), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "gotten COVID-19". Reporter stated she had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 15 to 18 minutes after I got the vaccine shot the back of my throat felt cold and had like a sore weird feeling that went down my throat and when I turned my head I could feel a tightness and a swollen feeling in my throat... these feelings were going from the back of my mouth/throat (where are my tonsils would be) down my esophagus to the collarbone area.... that is anaphylactic in nature, it just was not severe.   Also, about 45 min after getting the vaccine, right above my left temple and my left eye in that central region, my head just started hurting... a mild aching that lasted for about 30 minutes.   I had taken a 25mg Benadryl a half an hour before I got my shot to which by the time I started having the reaction the Benadryl was just starting to kick in. For me, it takes about 40 to 45 minutes for Benadryl to start working? And I had also been on 25mg Benadryl for a day and a half every eight hours before hand.   About 45 minutes later, it started to subside and then I took another 25mg Benadryl and a 20mg Famotidine immediately when I left.... they were going to give me another Benadryl there in a doctors office but they said once it started going down that I could take it when I get out to my truck. After taking the other Benadryl and the Famotidine about 45 minutes to an hour later the residual feeling went away. Total time was about 2 hours.
Chills for over two hours with fever/ headache increased heartrate of 120 - 140 for over eight hours.  Contacted ED department was told it was not reaction.
Information has been received from a licensed practical nurse concerning an 5 year old patient who on 15-MAY-2002 was vaccinated with a dose of VARIVAX (Merck). On approximately 26-MAR-2007, the patient experienced few pox lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
5 hours after vaccination yesterday (2/22/22), patient started complaining of pain and refusing to walk or bear weight on her legs. She is minimally verbal and thus was unable to offer details of pain character or specific location. Shortly afterwards, she developed malaise and fever up to 102F. Tylenol treated the fever and malaise but did not help the pain. She was seen today in the office (2/23/22). Fever and malaise have not recurred, but pain remains. Patient is now able to bear weight normally on the right leg but limps heavily on the left leg. No visible or palpable abnormalities on exam, incluing at injection sites.
Immediately after a whole blood donation, as I was walking from the donation chair to the waiting area I felt nauseous and lightheaded. Upon sitting in the waiting area I put my head down on a table and my vision began going dark. I was able to make eye contact with a phlebotomist who asked if I was okay, to which I could only shake my head ?no?. They rushed to me with ice packs and moved me back to the donation chair so I could sit in a recliner position. As I started to feel less faint they gave me apple juice, Oreos, and gordettos. I felt better within 30 minutes. The phlebotomist thought the reaction may have been due to a poor meal beforehand, which consisted of two litelife veggie dogs on white buns with ketchup, veggie chips, and cookies.
Temperature; Sweats; A Spontaneous report was received from consumer  concerning a unspecified age, female patient , Modern's COVID-19 vaccine(mRNA 1273) and experienced temperature and sweats. The patient medical history was not provided by the reporter. Concomitant medications were not provided by the reporter. On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 , via unknown  route and unknown anatomical location for prophylaxis of COVID-19 infection. After receiving the first dose the patient experienced Temperature and sweats.  Treatment history was not provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event temperature and sweats were unknown.
Chills; Achy neck and shoulders; Achy neck and shoulders; Second Dose: Arm Soreness; This is a spontaneous report from a contactable consumer (patient).   This 66-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, EP6955), via an unspecified route of administration, administered at arm left on 24Mar2021 (age at vaccination was 66-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history of the patient was included benign PVCs. The patient concomitant medications were not reported. Patient past vaccinations included eggless one that covers 4 strains, Flu Shot, she got a sore arm, not bad. The patient previously received first dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, EN6198), via an unspecified route of administration, administered at arm left on 03Mar2021 (age at vaccination was 66-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced heart palpitations, Little Arm Soreness, felt like she needed to rest her heart and pulse got up to 105 for just a few seconds. Patient states she was on no medication, has great blood pressure, and her check ups are good, she actually has kind of the lower blood pressure 112/89. On 25Mar2021, the patient complained of chills with no fever as well as achy neck and shoulders for 26 hours. Patient states after the second vaccine her arm was sore that evening on 24Mar2021 until 25Mar2021. Caller states she thought ya'll might be interested about the PVCs that lasted for 5 days. Patient states she doesn't know how her PCP knew about it, but she did, and sure enough the 7th day they ended, she got good info from somewhere. Patient states she rested with the first one. Caller is asking for more information about the third dose of the Pfizer Covid-19 vaccine after 8 months and if there is any indication that the third dose of the vaccine has the same side effects as the first two doses?. Caller states she has supplements there and she took antioxidants, Vitamins A, C, Zinc, Vitamin D, and she takes Vitamin D nearly every day. Caller states she probably took Beta Carotene and Vitamin E. Caller states she ate really healthy, fruits and veggies, lean meats. Caller states she is a healthy eater and had those at the house. Caller states that she is fine now but she thought Pfizer might want to know about this. At the time of this report event was recovered 25Mar2021.
Redness around injection site the day after. Swelling like a lump or knot under skin and pain increase second day. Third day itchy skin at injection site but less pain.
Patient developed muscle pain, fatigue in the evening after Shingrix administration. Patient woke up the following morning and had the same symptoms in addition to shivering, headache and a fever of 101.1 F. Patient checked her temperature again later and it was 101.4 F.
started having erythematous circular rash 1 day after vaccines given that progressed 1 week afterwards and diagnosed with possible cellulitis.
I received my first shot on April 5th, 2021, and my second shot on April 26th, 2021. I haven?t had a period since receiving my first dose. My menstrual cycle is now a week late, and I?m usually very regular.
Three hours after vaccine developed excruciating migraine that persisted 3 days. Still 4 months later migraines persist weekly.
Very large hives formed on my right shoulder, underneath both of my buttocks, behind my knee, and on my thumb.  All of the hives were painful. My thumb swelled up a couple of hours after I noticed the one on my shoulder and thighs, and I watched and felt as my thumb swelled up. The next morning I woke up and they were still there, but no new hives formed.
Sore throat, nausea, headache, body ache, fatigue for first 4 days. On day 3, intermittent shooting pain to left neck, TNJ and ear. On day 11, unilateral weakness of left facial muscles from forehead to platysma, with inability to close left eyelid, tongue deviation to the right.
In early June I broke out with the hives my second covid injection was on 03/19/2021. I went to the doctor and they determined it was hives and prescribed prednisone. I did have to go to Urgent care where they prescribed the prednisone. I took the prednisone as it was prescribed and the hives went away.
Low grade fever. Severe sore throat. Severe upper respiratory congestion. Diarrhea. Nausea/vomiting.
COVID arm/bright red spot/rash; COVID arm/bright red spot/rash; COVID arm/bright red spot/rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm/bright red spot/rash), RASH MACULAR (COVID arm/bright red spot/rash) and RASH (COVID arm/bright red spot/rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 VACCINATION SITE REACTION (COVID arm/bright red spot/rash), RASH MACULAR (COVID arm/bright red spot/rash) and RASH (COVID arm/bright red spot/rash). Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-068239 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068239:BROTHER-IN -LAW
Patient complained of soreness on her injection site. i.e. of pneumonia on 11/18/13. She was advised to do warm compress. On 11/21/13, she came to the pharmacy showing bruises on both arms, more on the left. Bruises came up 2 days after the shot. She said it's waning though.
Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, severe vomiting, total exhaustion.  These symptoms were severe, much worse than when I had the virus in December. I thought I was having a stroke and was minutes away from dialing 911.
Red rash -papules over entire body noted 06/25/02-worse when warm.