chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my skin on top of my feet burned, became hard and thick, my right big toe knuckle was prominent and reddish, and my right foot swelled up so much it was difficult to walk and I couldn't wear shoes.
On the evening of 12/28/20, I noticed mild pain in my left axilla when laying on it and upon palpation. The pain become slightly worse the next morning and has persisted through the time of this submission.   In addition, I noticed redness on my left upper arm around 12/28 or 12/29/20. It has spread more since that time and started slightly itching on 12/31/20. It is not raised.
48hr p/vax pt noticed bilat pruritus;intermit pruritus x 3 days;generalized over body, welts x 2 on rt arm 5 days p/shots, disappeared;reappeared (#2 large welts) on back 7 days p/shots;
EXTREME nausea that both Zofran and Phenergan wouldn't help. Fatigue, lightheadedness, headache, muscle/body ache, arm soreness. Nausea lasted for weeks and was unable to eat--had to get IV infusions. On 06/25/2021 I had shingles, which also worsened the GI symptoms, which included sharp stomach pains, no appetite, horrible nausea, inability to take fluids or food. (Vomiting is difficult due to a Nissen Fundoplication procedure for GERD in 1999.)  NOTE: I was diagnosed with COVID 02/06/2022, and am currently struggling with long-COVID symptoms (almost 7 months now): difficulty breathing, fatigue, insomnia, joint pain that has worsened, muscle weakness, brain fog/can't recall words/forget things.
fever; uti; seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing). Concomitant medication(s) included: LIBTAYO [CEMIPLIMAB], start date: 17Nov2021. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Ativan, reaction(s): "Allergies: Ativan". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6199), administration date: 15Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "skin cancer"; BNT162b2 (DOSE 2, SINGLE, Lot Number: EP7533), administration date: 05Apr2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "20May2021 graft at hospital and 22 lymph nodes removed", "22 lymph nodes removed". The following information was reported: SEIZURE (hospitalization, medically significant) with onset 25Dec2021, outcome "unknown", described as "seizures"; PYREXIA (hospitalization), outcome "unknown", described as "fever"; URINARY TRACT INFECTION (hospitalization), outcome "unknown", described as "uti". The patient was hospitalized for seizure, pyrexia, urinary tract infection (start date: 25Dec2021, discharge date: 28Dec2021, hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of seizure, pyrexia, urinary tract infection. Had seizures on 25Dec2021 from fever/UTI. She was sent home on 28Dec2021. She is now in much better shape. No Doctor said this was vaccine related but the reporter had no doubts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293267 same patient/drug/reporter, different dose;US-PFIZER INC-202300293266 same patient/drug/reporter, different dose;US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SIMPONI; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative, notes: Negative test 4 days after starting Paxlovid; (30Jul2022) Positive, notes: Positive test 12 days after starting treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received antiviral treatment for COVID 19 .Treatment start date was 18Jul2022.Treatment stop date was22Jul2022. Patient received other medication in 2weeks: Simponi and Plaquenil.  No follow-up attempts are possible. No further information is expected.
pt recv vax & dx autism;child mom was told by environmental MD that the autism was caused by a stealth virus which the MD says the child contracted from contaminated OPV;
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative:  employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
blacked out; was almost fainting; could barely think of what to do; very dizzy; I also thought I was going to vomit; sweating; Dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received BNT162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not have covid before vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Right), administration date: 06May2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "I got very dizzy and almost blacked out.", "almost blacked out.", "I was sweating and could barely think of what to do because I was almost fainting.", "almost fainting."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: 11Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant); LOSS OF CONSCIOUSNESS (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "blacked out"; SYNCOPE (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "was almost fainting"; MENTAL IMPAIRMENT (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "could barely think of what to do"; DIZZINESS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "very dizzy"; NAUSEA (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "I also thought I was going to vomit"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "sweating". The patient reported that after the 2nd and 3rd vaccines, upon waking up the following day, she got very dizzy and almost blacked out. She was sweating and could barely think of what to do because she was almost fainting. She also thought she was going to vomit when it happened after the 3rd vaccine (next day) but she didn't. She sat with her head down between her legs and the symptoms faded. Therapeutic measures were not taken as a result of loss of consciousness, syncope, mental impairment, dizziness, nausea, hyperhidrosis. No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning a patient who on an unspecified date, was vaccinated with PNEUMOVAX 23 (lot# 662599/1076X). It was unspecified if this was the first or second dose for the patient. Subsequently the patient developed "very severe" injection site reactions. The patient sought medical attention in the office. In follow-up, the office manager indicated that the patient was a 71 year old female with hypertension, overweight, hypothyroidism and no known allergies who on 10-FEB-2009 received a dose of PNEUMOVAX 23 (lot# 662599/1076X) into deltoid. On 10-FEB-2009, the patient experienced edema, epistaxis and pain at site of injection. The patient was treated with BENADRYL. The patient did not use steroid pack treatment. It took a week for the adverse events to clear. Subsequently, the patient recovered. It was reported the patient had no illness at time of vaccination and it was given at a new patient office visit. The reporter considered that the edema, epistaxis and pain at site of injection to be other important medical events. This is one of several reports from the same source. Additional information has been requested.
Started my menstrual cycle 6 days early, heavier than normal and increased cramping.  Also, many small clots being expelled
deltoid vaccine injection noticed 12hrs after injection, redness, swelling, warmth, closer to elbow than deltoid, no systemic symptoms, local reaction only
no adverse event; improperly stored VARIVAX was administered to patient; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W039294 exp date 11-DEC-2024) (dose and route not reported). The temperature excursion was 17.4 °F for a time frame of 2 hours. There was no previous temperature excursion.
5 minutes after vaccination, recipient became flushed, red in face, felt hot.  Reported to observation RN that she began feeling short of breath.  RN administered Epinephrine in left thigh.  Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
- unexpected, extremely heavy period with an amount of blot clots similar to what is passed after just giving birth - fatigue, nausea, light headedness
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling, pain and skin warm. On an unknown date, the outcome of the erythema, swelling, pain and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling, pain and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not provide any more information at the time of reporting but stated that she would call back on Monday with more information about the patient. This case was linked with US2018GSK135707, reported by the same reporter.
c/o of nausea and dizziness .  weakness.  symptoms resolved and pt went home
Moderna COVID-19 Vaccine EUA: Day of vaccine: Arm throbbing, sore at injection site (Upper left arm).  Took 600mg ibuprofen right after the shot and every 4 hours after.  Day 2: Entire left arm very sore and heavy, felt like the arm will fall off.  Woke up with congestion/tightness in lungs and yellow mucus.  Needed to take asthma inhaler and allergy meds.  Congestion cleared up.  Felt warm all day.  Low grade fever. Highest temperature was 100.1.  Took ibuprofen 800 mg every 4 hours  Day 3: Woke up with mucus/congestion/tightness in lungs.  Took asthma inhaler and allergy medication.  Cleared up. Arm still sore but slightly better.  Felt warm all day, highest temperature was 99.9.  Didn't feel like myself, like my head was in a cloud, very fatigue.  Felt like I was coming down with something all day but didn't get really sick. Weird feeling.  Some shortness of breath today while walking around.  Day 4: Arm slightly sore, shortness of breath, not feverish, slight congestion
SX's started 10pm on 12/6/16 - arm hurt at injection site, felt swollen and lumpy. By 7 am the next morning pt. was unable to raise arm easily over or above shoulder area without force. Towards the afternoon patient developed chills, no appetite and all over achiness. 24-30 hours post vaccination - pt developed welts and/or hives starting at injection site and traveled to patient's neck area (Thursday evening). Pt. reported no itch. Pt. reported adverse side effect lasted 3 days in total and by the second day SX's started to dwindle. Pt. treated SX's with ice.
Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swallow; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization.Medical history included gastrointestinal issues and high blood pressure. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination was high blood pressure meds, pain meds.On 04Mar2021, the patient was not eating, unable to eat without choking. Couldn't swallow. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Duration of hospitalization was 30. The patient had not yet recovered from the event.
Client states she developed redness near the injection site with swelling. Mildly warm to the touch. Denied itching.  She stated the redness and swelling lasted for one week before fading away.
On 01/05/2022 I took a PCR COVID test for a family gathering and the results were Positive on 01/07/2022. I started to experiencing symptoms the next day on 01/08/2022 like sore throat, lethargic, and a headache. I did have some sniffles but not a lot, body aches, and unable to get out of bed. On Monday 01/10/2022, my heart started beating fast and extra beats. It seemed like different symptoms with my heart and then it would be more a headache or earache. I contacted my doctors through messaging as soon as I got the Positive results. My Pulmonologist told me to start the Advair. I just went to an online site to fill out a form to do the Monoclonal Antibodies and received that 01/11/2022 and it later that day I felt better. The 12th I felt better but then the 13th I felt bad again. It was mainly lethargic and some heart issues but not as bad. My symptoms had improved by the 17th and 18th, but I was still tired. I recently decided to go to my PCP on February 15, 2022, because of some heart issues. I had an EKG and ordered an Echo Stress exercise test that happened in March. I also wore a two-week heart monitor. The heart monitor indicated three events lasting up to 7 seconds. My heart was racing 185BPM randomly every other day or I would feel my heart skipping a beat. The initial reason I went to see her is because I could not play my normal 6 hours of Tennis weekly. I could not talk or breathe after 1 hour of Tennis. I am monitoring this and will have another follow-up if I should take medication. My Pulmonologist I saw on 04/05/2022 and they prescribed Flovent twice a day along with Levalbuterol. That is helping and I will see her in three months. I feel the Monoclonal Antibodies kept me out of the ER. I am not sure if I should get another Booster due to this reaction. There is not enough information to let me know it won't exacerbate the symptoms I am already having.
ErythemaMultiform Redness at injection site has increased and up to 8 cm. Has warmth at injection site..
Concern that his palpitations he developed during deployment may be related to the AVA vaccines he received. July 09 assessed as having SVT with occas PVC's. Ablation was attempted in 09 but unsuccessful since sit could not be located. He saw cardiology in Jan 2011 in which a brief history was obtained and a request for records. Next cardiology visit was in Jan 2014 in which he reported fatigue and occasional skipped beat, no chest pain, dizziness, palpitations or SOB. He admitted to smoke 1/2 ppd, drank 24 oz of coffee every am and 2-3 32 oz of tea throughout the day. He had a repeat Holter in July showed occas PVC and PAC's and he is currently requesting a repeat EP visit. Exact onset date unknown. Only that it was in July 08.
pt recv 4 doses of typhoid;p/dose 4 pt exp mod-severe cramping w/diarrhea, nausea & mild h/a;
Patient verbalized cold chill after receiving the vaccine.  Patient was evaluated by onsite HCP and released home 11:49 am.
I started to get severe chills and a fever at 5pm - the chills lasted for a few hours until my fever broke while I was sleeping. Extreme fatigue and muscle soreness the next day. My autoimmune condition problems were triggered that month and I had pain in my shoulder and hip as well as a depressive mood swing.  My menstruation was about a day early - and I had extremely debilitating and painful  uterine cramping that lasted for several hours beyond what is normal for me. I cycle track my periods using the  app because I have clinical diagnosis for PMDD and most likely have endometriosis. Surgery is needed to confirm endometriosis, but I did have a pelvic ultrasound which confirmed I have a tilted uterus. I usually have one-two days of heavy bleeding and cramping, but this was undoubtedly worse.  I also follow the Autoimmune Protocol, which helps me monitor/treat my symptoms so I have very tight control over nutritional, lifestyle, and environmental factors impacting my periods.
Had Hep B vaccination 09/26/2002, on 09/27/2002 saw her with C/O headache and fever of 99.4 degrees. Saturday night 09/28/2002 pt was taken to ER having febrile seizure. Temp 102.1
sz-like episode 3 days p/vax;seen in er:2nd episode 8 days p/vax;occurred during feeding;family hx positive for sz;
Allergic reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age 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 HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient had an allergic reaction and ended up in the emergency room.   Reporter did not allow further contact
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided),by the pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility/family medicine center, for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
rt sided arm & eye twitching onset 10FEB99;11FEB99 active sz x 5-7min @ rt side then became lt sided;IV started phenobarb given;on going sx undergoing eval for sz disorder;  Per follow-up, child was dx with a condition not related to this vaccine called nesiclioblastosis which caused hypoglycemic seizures.
Accidently administered 1 dose of the shingrix adjuvant by itself. Realized the mistake and readministered the adjuvant  suspension with the  antigen component. The dose was administered on 11/29/2019. Called patient on 12/3/2019 to check up on him, he said he is not experiencing any adverse side effects, he is feeling fine.
Client report having COVID in November 10, 2020.  Client received first dose on 02/09/21 at 2 pm, reaction of SOB began two hours later.  SOB progressed to chest pain and fatigue.  She sat at kitchen table to relax and rest, fell asleep for 2 hours.  When she woke up she continued to have trouble breathing, drank some warm tea, went to bed and slept for 12 hours.  This is not usual for her sleep schedule.  The next day she felt better for a couple of hours then had some difficulty breathing again.  She went to Urgent Care.   EKG and chest X-ray preformed came back normal.  Blood pressure was elevated.  Client given 4 puffs of an inhaler.  Discharged to home.
Patient received adult dose HAVRIX Hepatitis A vaccine when she should have received a pediatric dose through the age of 18.
This spontaneous report was received from an other health professional (healthcare worker) refers to a 5 week old patient of unknown gender. On 28-OCT-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015558. Additional information has been requested.
Fever ~101 degrees F for ~40 hours after shot. Controlled with infant advil and acetaminophen (Triaminic) from duration of shot for 2 days after. Screaming and crying in middle of night after first night. Extreme constipation with obvious symptoms of pain since then. BM frequency is ~ 1/10 days, and in most cases must be induced with glycerin suppository, due to fussiness of child.
Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a deceased male who received a dose on an unspecified date. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV40). The attorney also alleges that the decedent became ill with Simian Virus 40-related disease, including malignant brain cancer, and subsequently died on 2/18/01 at 10:00 PM. No additional information was available at the time of this report.