chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy red rash on face and ears; Fatigue; fast heart rate; dizziness; out of breath; itchy in ears and face; arm soreness; A spontaneous report was received from a consumer concerning a 41-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  The patient's medical history was not provided. Concomitant medications reported were Methimazole for hyperthyroidism for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) arm soreness. On 14 Feb 2021, the patient experienced the event(s) fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 15 Feb 2021 the outcome of event(s), rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face was resolved. The outcome of event(s), arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness was unknown.
Patient experienced a very sore arm day of the injection. the next day the arm - (RC) was swollen, red and angry. She felt weak. She saw her PCP who told her she had an allergic reaction to the vaccine and gave her a steroid injection. the reaction subsided with hours after the steroid. She had no reaction at the flu injection site. Hx of PPV vaccine 11.17.10.
Exposure during pregnancy; No additional AE reported; patient inadvertently received a dose of GARDASIL 9 instead of FLU vaccine; This spontaneous prospective pregnancy report was received from an office manager, via field representative and refers to a 30-year-old female patient. Her concomitant medications included prenatal vitamins and loratadine. The patient's pertinent medical history included history of thrombocytopenia. Reported allergies included allergies for tree nuts, mango and gluten.  She became pregnant with last menstrual period (LMP) on 11-OCT-2020 and estimated due date on 18-JUL-2021. On 21-JAN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687291, expiration date 11-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis, instead of influenza virus vaccine (unspecified). The pregnancy outcome was pending. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R034548 (expiry date: 29-DEC-2019) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F) /9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009082: US-009507513-1906USA009513: US-009507513-1906USA009509: US-009507513-1906USA009522:
Since getting the vaccine her husbands medication seems to be ineffective; Since getting the vaccine her husbands medication seems to be ineffective; This is a spontaneous report from a contactable consumer (patient's wife). A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included Parkinson's disease for which patient took carbidopa/levodopa. Reporter stated that since getting the vaccine, patient's medication seems to be ineffective, dosage has been adjusted, he has went to the doctor and emergency room. There Is something blocking the abospriton of the carbidopa/ levodopa?     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness and swelling of ears, hives over face and upper body. Vomiting and then diarrhea. Patient sent to ER - given Benadryl with complete resolution. Was able to take bottle of formula before discharge. No problems since.
Around 6-8 hours after receiving my COVID-19 vaccine, I developed a headache. Fatigue and general weakness set in slowly as the night went on. I also developed a fever in the middle of the night. I felt like I had the flu. The aches turned into a more severe stabbing pain. I described it to my doctor and friends as a painful sensation that I could feel traveling through my body, but that was accompanied by overall body aches as well. The traveling pain all over my body lasted for around 3 days. On day 2 and 3, I had trouble walking, was in pain all the time, was very weak, and was off balance. However, the pain lasted for almost 5 days. It gradually got better each day, but I felt the effects of everything for at least 3 weeks. I was down for 5 or 6 days where I couldn't work. I was able to go back to work and slowly worked my way back up but ever since I started getting the vaccines, fatigue has doubled and tripled in my life in general. When I actually contracted COVID-19. The effects were almost the same as when I get a vaccine. I do have an auto immune disorder, so I don't know if it has anything to do with that, but I went through the same thing each time.
Hospitalization for COVID-19 Pneumonia on dates 8/30/22-9/2/22.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
PAtient presented to the ED on 12/21/21 for right great toe infection. Vascular surgery was consulted due to CT angio aorta abd through bilateral lower extremity showing right popliteal artery occlusion (left common iliac artery diseased with at least 50% stenosis through the external iliac artery). Vascular (Dr. ) performed right thigh cutdown for angioaccess to bypass graft; right runoff angiogram; balloon angioplasty of popliteal to ATA. She was started on heparin gtt until her INR was therapeutic above 2 on warfarin. ID was consulted on 12/22/21 and recommended antibiotic therapy until discharge (prescribed ceftriaxone 12/21, then transitioned to cefazolin from 12/22-12/29). Patient underwent right first toe amputation, silver bunionectomy on 12/23/21 with Dr. of podiatry. Discharged to step down. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Headache, chills, myalgias, joint pain, fever started approximately 12 hours after vaccine and lasted approximately 12 hours total. Most symptoms improved with Tylenol and naproxen but fever 100.4F persisted for 6 hours despite medications.
1-11-16: Diagnosed with streptococcus pneumonia bacterium 4 (four) days after PNEUMOVAX. 1-17-16 signs of impetigo. 1-28-16 Diagnosed with impetigo.
Dose administered 4/12/22- no date on the Moderna vial. Administered. Expiration date was 3/25/22. Vaccine was expired. No adverse outcome.
Subsequent to receiving varicella virus vaccine live, pt developed chickenpox. Additional information has been requested.
Information has been received from a health professional concerning a 6 yr old white male with acute pharyngitis since 19Aug00 and no allergies who on 08Sep00 was vaccinated with a SC first standard dose of varicella virus vaccine live (lot 634502/0538K). Concomitant vaccine administered at the same time included a dose of measles-mumps-rubella vaccine. Concomitant therapy included cefaclor (Ceclor), PO, amoxicillin PO, and ampicillin IM all for treatment for acute pharyngitis. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 02Dec05 lesions started on the pt's face and progressed to his neck, arms and torso. The pt was afebrile, but had itching and an ulcer in his mouth. He was treated with cyproheptadine hydrochloride (Periactin) and avena (Aveeno bath). There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 02Dec05, at 10:00AM, the pt experienced breakthrough varicella, described as mild. Additional information is not expected.
pt recvd vax; high pitched cry; unusual cry off & on for 3 hrs;seen in er & given dph;
headache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was asking if she could take ibuprofen. She had a little headache after the 1st dose. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in the left arm  on 19Jan2021 16:15 as a single dose for covid-19 immunisation. The patient's medical history included supraventricular tachycardia (SVT), atrial fibrillation (Afib), atrial flutter, colon cancer, endometrial cancer, Lynch Syndrome, asthma, osteoarthritis, lung nodules being watched, kidney cysts, obesity and enlarged liver all from unknown date. Concomitant medications included metoprolol tartrate; alprazolam; acetylsalicylic acid (ASPIRIN LOW); ascorbic acid (VIT C); and colecalciferol (VIT D3). The patient previously took epinephrine and experienced sensitivity (reported as (sensitive to epinephrine due to heart arrytmia). The patient received the first dose of bnt162b2 (lot:ELI284) on 29Dec2020 in the left arm for covid-19 immunization. On 19Jan2010 at 16:15, the patient experienced within the first minute or two, she felt her heart rate start to race.  She used Kardia device to check it and she was in Tachycardia at 16:15. The patient mentioned that she carry device with her since she have a history of SVT, Atrial Flutter, and AFib, with prior ablations. Patient was pretty familiar with what Tachycardia feels like so she was pretty sure she was not having an allergic reaction to the vaccine, but rather the vaccine had triggered her heart arrhythmia.  After continuing to monitor her HR, for approx. 20 minutes, and it continued to stay at 135 -145, the doctor who had administered the vaccine took her to the local hospital to have her evaluated. The patient received this vaccine at the facility where she was employed. The outcome of the events was recovered on an unspecified date in 2021.
Headache, NauseaVomiting, hot sweats, feet swelling,  Narrative:
sz w/fever on 27DEC92; taken to ER; sent home w/med; had second sz, taken back to hosp & hospitalized; t105 w/sz;
The patient experienced diarrhea 2 hours after the immunization and dizziness 2 days later.
07-27-08 pt states woke up in the night with severe itching around buttocks area. Noticed red raised whelps with yellow head. Also was very fatigued, very nauseous and had diarrhea. MD visit. NP called stating possible reaction to MMR. Depo Medrol and Predn. given.
For 3 months it was very painful to bend down, reach up, lean forward, sit, lay on my side or stomach, and carry anything over a couple of pounds.; It got worse right after her second vaccine; At that 3 month point I went back to my doctor and got a steriod injection, but it did not help the inflammation.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, 38-years-old at the time of vaccination), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:45, as single dose for covid-19 immunization. Medical history included endometriosis, polysystic ovarian syndrome, irritable bowel syndrome (IBS) and wheat intolerance. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Concomitant medications included fish oil; colecalciferol (VITAMIN D); fluoxetine hydrochloride (PROZAC); acetylsalicylic acid, caffeine, salicylamide (BC) and multivitamins. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, 38-years-old at the time of vaccination), via an unspecified route of administration, administered in arm left on 10Feb2021 at 11:45, as single dose for covid-19 immunization. It was reported that she developed costochondritis two weeks after her first vaccine. It was hard to breathe, and she was in intense pain. She was a teacher and would lay on her classroom floor during her plan time because the pain was so bad. On an unknown date it got worse right after her second vaccine. A week after her second dose, doctor started her on a steroid pack, and at that point she was able to breathe better. For 3 months it was very painful to bend down, reach up, lean forward, sit, lay on my side, or stomach, and carry anything over a couple of pounds. At that 3 month point she went back to her doctor and got a steriod injection, but it did not help the inflammation. The next week she did start taking 500 mg of curcumin twice a day, and that has helped decrease her pain level. Now (5 months after the vaccine) she was able to do more physical tasks, but still couldn't do things like carry a basket of laundry without being in pain for hours afterward. For the past 6 weeks she had been off work, and rest has also helped her heal. Adverse events resulted in doctor or other healthcare professional office/clinic visit. As treatment patient underwent X-ray and received steroid pack, steroid injection. Outcome of the events was resolving.  No follow up attempts are possible. No further information is expected.
What feels like tennis elbow in my left elbow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LAMICTAL; DROSPIRENONE AND ETHINYL ESTRADIOL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6207), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0151), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FJ8762), for COVID-19 immunization. The following information was reported: EPICONDYLITIS (non-serious) with onset 23Sep2022, outcome "not recovered", described as "What feels like tennis elbow in my left elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of epicondylitis.  Additional information: the patient had no other vaccine in four weeks. She felt like she had tennis elbow on her left elbow, which was her non-dominant hand and was not overused or prone to tennis elbow. It was also reported the event occurred progressively 2 weeks after the vaccine, and was still a problem at the time of the report. She did not have COVID prior to vaccination, and was tested for COVID after vaccination.
When patient arrived for her second dose (today) she stated that the morning after her 1st dose (12/22/21), she could not get out of bed without passing out or feeling like she was going to vomit. She also stated that she had chest-tightening feeling for a week and a half after the vaccine. She recieved the first dose on 12/21/21.
Period problems after vaccine.  No period for 2 months after vaccine. First period that came back was extremely heavy, painful and lasted 12 days.
Symptoms started  on Sat 4/10 with fever/chills/shaking/muscle soreness and quickly moved to  terrible nausea and fatigue. Fever ranged 99.5 at 9:30a and by noon is was 101.5. Fever stayed at 101 until it broke late Sunday night. Fatigue and muscle soreness remain as of 10:53a on Tues 4/13 (the time of this reporting.  I feel it's important to mention, I had a confirmed Covid-19 test on July 17, 2020 and the symptoms I had post shot mirrored the symptoms i had when i had the actual virus. Only differences are when i had the virus, the fever stayed over 102 and I was sick in bed for more then a week.
Patient expereinced flu like symptoms: fever, headache, fatigue 4 hours after vaccination. 4 days after vaccination, developed numbess in hands, feet and knees and shortness of breath. Also complained of right upper quantrant pain with inspiration. Was evaluated in an urgent care setting and had a negative work up for blood clot and normal labs, ECG, et.
got the shot, still had shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingles shot and still had shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Fever blister on mouth; This case was reported by a consumer and described the occurrence of fever blister in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 5 months ago) and fever blister (several before the vaccination but they were healed).   On 24th September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 3 days after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right upper arm. The patient experienced fever blisters on mouth. The patient asked whether the vaccine could cause fever blister afterwards. The patient experienced no fever just the blisters on mouth. The patient was not sure if it was related or not. The patient told the fever blisters were several before the vaccination but they were healed and then on Friday several popped up above where the others had been. The patient had already sent the doctor a message earlier. The reporter gave consent for follow up.
Unable to walk due to numbness and tingling in legs, sudden collapse. Unable to sit up without assistance. Diagnosed with transverse myelitis.
4JUN91 mom states pt started crying last eve approx 6PM & continued crying on & off all night & today; Has had fever 102.2, vomited, pulling @ ears; MD felt was rxn to vax;
patient mentioned that 2 days after recieving the flu shot his back startedhurting. He cantacted me and i advised him to call his physician he did and the dr said it is the flu shot and it is GBS and for him to to take vitamin B6. Before recieving the flu shot he did not mention any previous reactions. Patient is doing better.
I woke up and didn't feel good. I felt lightheaded and my smart watch read that my heartrate was at 170. My husband took me to hospital. They checked my blood pressure and EKG and saw I was in A-fib. It took multiple medication and they put me on an IV to monitor my heart rate and it went back to normal.
high fever; aches; sweats; chills; no sleep; my arm hurts!!!; will not be able to do anything for a couple of days,; feeling crappy; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, for tolernace refer case US2021AMR063110).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 36 hrs after receiving Shingles vaccine, the patient experienced fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, pain, sweating, chills, sleeplessness and pain in arm were unknown and the outcome of the feeling bad and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063110:Same patient , 1st DOse