chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left leg and both ankles swollen; both ankles swollen; burning sensation.; left eye was closed; Stress; confused; unbalanced/unsteady; injection site is swollen; slight fever; rash on his face and lips; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left leg and both ankles swollen), JOINT SWELLING (both ankles swollen), BURNING SENSATION (burning sensation.), OCULAR DISCOMFORT (left eye was closed) and STRESS (Stress) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included TAMOXIFEN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left leg and both ankles swollen), JOINT SWELLING (both ankles swollen), BURNING SENSATION (burning sensation.), OCULAR DISCOMFORT (left eye was closed), STRESS (Stress), CONFUSIONAL STATE (confused), BALANCE DISORDER (unbalanced/unsteady), VACCINATION SITE SWELLING (injection site is swollen), PYREXIA (slight fever) and RASH (rash on his face and lips). At the time of the report, PERIPHERAL SWELLING (left leg and both ankles swollen), JOINT SWELLING (both ankles swollen), BURNING SENSATION (burning sensation.), OCULAR DISCOMFORT (left eye was closed), STRESS (Stress), CONFUSIONAL STATE (confused), BALANCE DISORDER (unbalanced/unsteady), VACCINATION SITE SWELLING (injection site is swollen), PYREXIA (slight fever) and RASH (rash on his face and lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included unspecified anxiety pills (10mg).  Treatment medications were not provided
This spontaneous report as received from a physician, via a company representative, refers to young female patients of unknown age (no specific patient information was provided). On an unknown date the patients were vaccinated with GARDASIL. Dosing information, route of administration and lot numbers were not provided. The physician reported that she had not seen a decrease in LEEPS (loop electrosurgical excision procedures), colposcopies and positive PAP tests in young patients who had been given GARDASIL. Causality assessment was not provided. Additional information has been requested.
syncope, patients blood pressure was very low - they hadnt eaten all day and were dehydrated
Pt states she has an full body itch from scalp to toes, but no visible rash.
Left sided axillary lymphadenopathy, with self-limiting pain lasting approximately 3 days, and lymphadenopathy persisting.
Lip tingling, burning, developed blister, HSV appearance w/no previous history of HSV outbreak. Next day, further HSV like lesions appeared on torso/back/buttocks/chest. Vaccine given was live flu mist.
Client reported  onset of chills, fever, arm pain, and a rash under her axilla bilaterally 24 hours after receiving the first dose of Moderna COVID vaccine. The client stated the rash was itchy and lasted two to three hours.
4 weeks pregnant (unknown at the time)  Shakey, nauseous, weak, fatigued, no fever, hot/cold chills Lasted 12 hours
Vaccines administered 3/24/03. Patient's mom returns to clinic for PPD reading and shows provider left deltoid with erythema, hot, itchy area. Mom reports is better on 3/26/03 than 3/25/03. Symptoms improving per mom.
Pt recvd DTP/HIB/OPV & @ 5PM cont to be unconsoleable crying x/for 1 hr between 230-330; physical exam WNL;
shot area is broke out with a rash and itches and is swollen. I treated with Benadry cream and the itching stopped but returned later.
Initial report received on 04 April 2008 from a health care professional.  A four-month-old male patient, with no past medical history, had received a second dose injection of ActHIB, lot number unknown; a second dose injection of Pediarix, manufacturer GSK (reported as Merck), lot number unknown; and a second dose injection of Prevnar, manufacturer Wyeth (reported as Merck), lot number unknown; on an unknown date.  There was no illness at the time of vaccination, and the patient was on no other medications.  Approximately 11 days post-vaccination, the patient developed petechiae.  Diagnostic testing revealed an unspecific platelet aggregation disorder.  PT, PTT, and platelet count were within normal limits.  At the time of this report, recovery status was unknown.
I had lost my smell. I had a cough and runny nose. I went to the doctor's office on 11/14/2021 and was diagnosed with COVID-19.
pt developed large area of firmness, pain and swelling of left arm and shoulder 1 days after receiving vaccines
Less than one month after the second shot, I developed polymyalgia rheumatica.  Just had my third shot on Wednesday.  Today is Friday.  Thursday night was in whole-body pain from 1 a.m. to about 6 a.m.  Am exhausted but the pain is diminishing  Am currently down to 9mg prednisone.
PATIENT LEFT FACILITY AFTER OBSERVATION PERIOD WAS COMPLETE.  PATIENT RETURNED TO FACILITY AND REPORTED "LIKE A WALNUT"  IN THE THROAT.  EPI ADMINISTERED IN LEFT THIGH. 911 CALLED.   EMTS ARRIVED STARTED IV BENEDRYL AND ZOFRAN.  PATIENT TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
1st dose Apr2022/ Second dose Oct2022; have gout/About 2.5 wks after Oct 2022 Pfizer shot, I had a major attack in my left hand/wrist; I feel my joints everywhere in my body all the time now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Apr2022, for COVID-19 Immunization, reaction(s): "gout". The following information was reported: ARTHRALGIA (non-serious) with onset 2022, outcome "not recovered", described as "I feel my joints everywhere in my body all the time now"; GOUT (non-serious) with onset 2022, outcome "unknown", described as "have gout/About 2.5 wks after Oct 2022 Pfizer shot, I had a major attack in my left hand/wrist"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2022, outcome "unknown", described as "1st dose Apr2022/ Second dose Oct2022".  Additional information: The patient having an adverse reaction to the past 2 Pfizer Covid-19 vaccinations and submitted my issues in the CDC VAERS reporting. Until after Apr2022 shot, gout attacks were at best mild and rare, maybe 1 attack in about a year. After Apr2022's shot, about 2mos/2wks. The patient had the worst attack lasted over 4wks in my foot/ankle. About 2.5 wks after Oct22 Pfizer shot, had a major attack in left hand/wrist. The patient felt like joints everywhere in body all the time now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient contacted office on 3/28/19 at 1:20PM reporting immune reaction on arm which that morning started with mild swelling and redness on subcutaneous injection site. Patient complained of itchiness and noticed redness. Patient then was scheduled same day for reaction. MD seen patient recommended patient to take 25 MG BENADRYL, able to take up to 2 tabs for reaction and also given CLARITIN to help with redness and swelling, patient was to follow up if symptoms did not improve. Allergy added to her list and filled out VAERS form.
ADMINISTRATION OF VACCINE WITH A DOSE THAT WAS FROZEN TWICE; This spontaneous report received from a health care professional concerned a 68 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-NOV-2021, the patient experienced administration of vaccine with a dose that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine with a dose that was frozen twice was not reported. This report was non-serious.
Patient stated "I'm not feeling very good." several times and then had a tremor in his left arm, started staring blankly ahead and then lost consciousness. He seemed to be exhibiting a slight wheezing sound and so was helped to the ground in order to open the airway and prevent a fall.  Upon lowering to the floor, healthcare providers were on scene and checking vitals. Pt never stopped breathing or lost pulse; he came to shortly after being lowered to floor. Upon regaining consciousness, was foggy and someone disoriented. He was taken to an observation bed in the adjoining health clinic.
No symptoms whatsoever except about 5 days later I started getting headaches and three months later they?ve never subsided.
Pt vaccinated with DTP/OPV developed fever of 103.2, swelling and warmth at injection site, wheezing and asthma following DTP/OPV immunization.  Duration of illness - 6 days.
cold symptoms, congestion, cough every once in a while, slight headache. starting 10/12/21. LOT # not available for vaccines
Headache, RespDepression, NauseaVomiting, Injection site bruising and pain, headache, insomnia, nausea, shortness of air with exertion Narrative:
The next morning I woke up with significant pain at the injections site. There was also a half dollar size knot in the arm and significant erythema. There was swelling as well diffuse upper arm. To this day there is knot in deltoid muscle. Still continue to have joint pain and continued myalgias. Have been having neck, lower back pain. Had nosebleeds on 7/13 and 7/14. Strep throat on 7/15 with no known contact. Have been dyspenic with exertion as well. Have also been having significant headaches that are not my typical migraines.
Pulsatile tinnitus, Pain in the left cranial ocular region, inability to close eyes properly resulting in corneal ulcer, hot flashes for two plus weeks, night sweats, irregular menses,  heart pain and cardiovascular impairments all within the first month following. Onset began the day after vaccination. Menses has returned to normal two months later. Two months post vaccination, tinnitus is still present, dry eye and drooping left eye indicating mild Bell's palsy reaction. Heart inflammation still present.
103 fever on and off x 2 days; dizziness x 1 1/2 day; swollen/painful lymph nodes x 4 days; body aches/fatigue x 2 days
has developed rash and urticaria to arms and legs about 5 days after vaccine administration.  Was started on benadryl and claritin.  The uticaria was wearing off with medication however will presents itself.  The urticaria flared and then developed cellulitis one month later to left thigh around vaccine administration site.  Was treated with antihistamines, steroids and antibiotics
On 01/22/2001 the patient developed shingles and presented to the physician's office with a discolored rash on her right arm which resembled "Varivax" A culture was done to diagnose shingles vs. contact dermatitis. The smear was positive for herpes and acyclovir was started. As of 01/26/2001 the patient was still taking acyclovir. Additional information has been requested.
took the poke and had an awful case of it/Suspected Vaccination Failure; awful case of it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2022, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the poke and had an awful case of it/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: awful case of it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient's parent via interactive digital media. The patient took the poke (shingles vaccine) against his/her advice. She had an awful case of shingles this past summer into Christmas.  Now he/she had read more victims of the poke were getting it in their 30's and 40's.  The side effects of that poison would never end. This case was considered as suspected vaccination failure as details regarding completion of primary 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.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 lot # L019297, expiration date- 18-AUG-2017, lot no. L02015, expiration date- 16-AUG-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. This is one of several reports received from the same reporter. Additional information has been requested.
7:55 a.m. Client received a flu shot in left deltoid. Gave her a sheet on (What you need to known 2006-07 Influenza vaccines. instructed her to stay around people for the next 30 minutes in case of an allergic reaction. 8:10 a.m. Client came back to office complaining that her throat feels tight and has tingling in her hands. Client states" My throat started feeling different when I got back to class but it kept getting worse. My throat has a fullness to it now it is getting worse." 8:15 a.m. Epi-pen 0.3 mg administered to RIGHT THIGH LOT#5EM436 expires 03/07. 2 Puffs from Albuterol inhaler and Benadryl (50mg) given. Person name called ambulance service and client's husband. Blood pressure 140/80, pulse 90. 8:25 a.m. Ambulance Service arrived and transported to hospital emergency room.
Shivers, chills, shaking spells, episodes of feeling cold, fatigue, washed out, malaise for 2 days.
some muscle aches 2 hrs post inject; jaw complaint 4 hrs post inject; jaw stiffness & thick tongue, SOB; no erythema or wheezing; dystonic reaction;
48 hours after administration of the vaccine, developed burning/tingling spots (quarter to a silver dollar in size) on arms/legs that travelled to different parts of the body including back, face, feet etc.  This was not a constant but was frequently intermittent. Due to this very uncomfortable adverse event, I did not receive dose 2 due to fear of worsening symptoms and did notify my HCP electronically (not in a clinic visit). The symptoms of this adverse event have continued until present although is now much rarer of an occurrence. Nothing noted that exacerbates symptoms-they just occur.
Information has been received from a registered nurse concerning an 80 year old female with allergies to PENICILLIN, iodine and CODEINE and a history of hypertension, bronchiectasis and osteoporosis, who on 23-OCT-2008 was vaccinated with PNEUMOVAX (Lot # 660717/0224X), 0.5ml, intramuscularly. The nurse reported that on 24-OCT-2008, the patient experienced pain, redness and swelling in the arm of administration. The pain was experienced from the patient's shoulders to her elbow. It was noted that the pain lasted for several days. On 20-NOV-2008, the patient recovered. The patient sought medical attention via telephone. Follow-up information received from the physician indicated she was a 80 year old female patient, with PENICILLIN, iodine, CODEINE, RAMIPRIL and NIACIN allergies and a history of hypertension and osteoporosis, who on 23-OCT-2008 at 14:30 PM was vaccinated with the second dose of PNEUMOVAX (Lot #660717/0224X), 0.5ml, intramuscularly in the left deltoid. Concomitant therapy included (ECOTRIN), calcium (unspecified), vitamin D (unspecified), vitamin E, LABETALOL HCL, BENICAR, BONIVA and omega-3 marine triglycerides. The patient had bronchiectasis at the time of vaccination. The physician reported that on 24-OCT-2008 at 8:00 AM, the patient had a large area of swelling and redness at injection site, lasting several days. The physician stated that the symptoms were treated with ice packs with resolution. No further information is available.
606 doses were given after expiration date; Vaccine is placed in refrigerator 04 Nov  2021, expired product date on 13 Oct 2021, administration date on 15 Nov 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 04 Nov  2021, expired product date on 13 Oct 2021, administration date on 15 Nov 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 04 Nov  2021, expired product date on 13 Oct 2021, administration date on 15 Nov 2021). On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 04 Nov  2021, expired product date on 13 Oct 2021, administration date on 15 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 04 NOV 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.  Treatment medications were not reported.
Tingling; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 15Mar2023 as dose number unknown, 0.5 ml single (Lot number: FN5548, Expiration Date: 31Jul2025) at the age of 18 years intramuscular for immunisation, Device Lot Number: FN5548, Device Expiration Date: 31Jul2025. The patient's relevant medical history included: "Anxiety", start date: Jun2022 (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 15Mar2023, outcome "unknown"; PARAESTHESIA (medically significant) with onset 15Mar2023, outcome "not recovered", described as "Tingling". The patient had vaccine on 15Mar2023 and 3 hours later, had tingling down his left leg and chills. On 16Mar2023, it is in his right leg and also feels like it is in different parts of his body, but patient can't pinpoint or explain. It was also reported that the tingling has worsened and spread to different areas of body. Patient also has chills and doesn't feel right, feels funny. The reporter considered tingling as serious for medically significant event. The vaccine was available to be returned.; Sender's Comments: Based on the close temporal relationship, the association between the event paraesthesia with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
15 minutes after I received my shot I started to feel dizzy and light headed and my throat started to swell shut
This spontaneous report as received from a physician refers to a 56 years old female patient. On an unspecified date, the patient was vaccinated (assuming subcutaneous) with a 0.65 ml dose of ZOSTAVAX (lot# not reported). Physician informed that a female patient was hospitalized for experiencing "cellulitis at the injection site." The patient was still at the hospital to date but the patient duration was unspecified by the reporter. Cellulitis at the injection site was considered as disability and an other important medical event by the reporter. The outcome of cellulitis at the injection site was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer 6mo-4yo EUA, health surveillance program, and screening form reviewed with mother, no concerns. Mother requesting client to be vaccinated in vastus lateralis instead of deltoid. Issued immunization record card. Began 15 minute observation after administration. Five minutes after administration, client fell. RN observed client brace with arms and knees, did not hit head. Client slow to respond to mother calling client's name. Client stood up unassisted and mother picked up into lap, then client's eyes became unfocused, lip color paled, skin paled, and client became unresponsive. After five seconds, client spontaneously became alert and went to sit up. Mother and RN encouraged client to remain lying down. Water and graham crackers provided; client able to tolerate. Mother stated client has passed out before with vaccines; mother also admitted personal history of passing out with vaccines, blood draws, and medical procedures. Client answers questions appropriately and engaging with mother and RN. After five minutes, mother encouraged client to try sitting up. Client able to tolerate sitting up. Lip color pink and skin color returned to normal. After five minutes of sitting, mother asked client if client feels okay. Client stated feeling okay. RN escorted mother and client from clinic to private vehicle.
Mother called 07/23/02 stated daughter had been fine all day after injections but woke up this am was 102 degrees temp/chills/vomiting x 1. Very weak-unable to get out of bed. Recommended calling her doctor. Saw doctor, he flet it was the Td shot. Stated arm slightly reddened/warm to touch. Mother stated daughter fine Thu am 07/25/02.
Nausea, vomiting, diarrhea, headache, dizziness, fatigue, low grade fever (100.8?F), body aches, joint pain, abdominal pain, chills, insomnia
Pt had vasovagal event after injection.  HR fell to 43, BP  fell to approx. 60/40.  Pt given water, snacks, coca cola, and monitored vitals for 10 minutes.  BP increased to 95/65 and HR increased to 65 bpm.  Pt monitored until felt well.
p/recv vax pt within 24hr devel a swollen arm w/12x7cm area of redness and slight induration starting 3cm elbow and extended above shoulder