chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First Dose - just a sore arm Second Dose - Morning after (approx. 10:00 am) injection began to feel chilly and by noon was running a low grade fever,  stomach was a little nauseated with a slight headache and tired.  By 4:00 in the afternoon temperature elevated to 101 degrees and felt ache.  Took Tylenol and went to bed.  Woke at 3 am and felt better and took another Tylenol.  I was able to get up, shower and eat by 8:00 am and continue my plans.  Sore arm for 3 days,
postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality assessment was related.
Mother reports heavy breathing, high fever-101, sore throat, and vomiting.  Took child to urgent care who diagnosed double ear infection and albuterol inhaler.
I feel very tired and fatigue all the time. On edge all the time. I feel empty on the inside, my head feels like I am in a fog all the time. Am very emotional all the time. I consider myself a very strong person. But every since the vaccine, am very mody, crying and angry all the time. I have no patience for people anymore. I was never like that at first. I was a out going type and now I always want to be a lone. Both of my arms feel very heavy and tingling all the time.
felt a burning inside; lips were burning; hot sensation; A spontaneous report was received from a consumer concerning a 28 years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a burning inside /burning sensation, lips were burning /oral discomfort, hot sensation /feeling hot.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, celecoxib for drug use for unknown indication.  On 28 Jan 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event(s) felt a burning inside, lips were burning, hot sensation.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), felt a burning inside, lips were burning, hot sensation was unknown.
I had increasing light-headiness that would come and go. I went to see my NP and she put a heart monitor on me for 2 weeks and it showed a lot of atrial tachycardia. She has now sent me to a Cardiologist who is trying to figure out what's going on. I've had increasing difficulty hearing from my left ear. I continue to have the light headed spells more and more often.
Right thigh swelling, tenderness, and warmth of approx. 10x10 cm in area.  Overlying redness with localized urticarial-type rash.
The next day after the second shot, my right foot got acute pain. I had some  fatigue  on my left foot on the day I took vaccine and I had got it examined by the doctor, He did. To find any issue on my left foot and suggested it might be a regular sprain. He also examined throughly the right foot and it was perfectly fine in the day time of vaccinations. The pain on right foot joints got so acute that I could not move out of my bed. I waited for two days hoping that the vaccine effect will go in couple of days.but it became unbearable. I saw my pcp and the blood work showed erratic inflammatory markers and unusable high glucose very low platelets and I was given steroid for six days. The inflammation was coming down when I was on med and bed rest, last Saturday my right heel started showing a new and sharp throbbing pain. I went the ortho and they found that possibly my burssaties sack is inflameated. The pain is so unbearable that I am, prescribed some opioid based pain killers, the PCP and hematologists had a discussion , I was told that I may be developing auto immune disorder. I never had a history of ITP.  I am still hopi g it is a shock and body will calm down soon but I am on so much in pain and in a small place to get an immediate medical attention is so hard.
Severe upper body aches - upper back, right shoulder/pectoral area. Hurts to cough & sneeze.  Taking 600mg motrin to help with pain; Severe upper body aches - upper back, right shoulder/pectoral area. Hurts to cough & sneeze.  Taking 600mg motrin to help with pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6203, Expiration Date: not reported) via an unspecified route of administration in left arm on 20Feb2021 14:45 as dose 1, single for COVID-19 immunization (at the age of 51-year-old, non-pregnant) . Medical history included thyroid, PCOS, arthritis, obesity. Patient had no allergies. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); guanfacine; ergocalciferol (VIT D); levothyroxine sodium (LEVOTHROID), z. Patient received other vaccine in four weeks Shingrix via an unspecified route of administration in left arm on 29Jan2021 as dose 1 for an unspecified indication. Patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced severe upper body aches - upper back, right shoulder/pectoral area, hurts to cough & sneeze taking 600mg motrin to help with pain on 22Feb2021. Patient received treatment with 600 mg motrin to help with severe upper body aches - upper back, right shoulder/pectoral area, hurts to cough & sneeze. The outcome of the events was not recovered.  No follow up attempts are possible. Information about Lot/Batch can not be requested. No further information is expected.
mom states 2 days p/ vax rash devel in face & chest non-pruritic, no T.
Breakthrough case admission after 4 vaccines Pfizer 3/4/21 lot# EN6206;  Pfizer 3/5/21 lot# EN6206;  Pfizer 10/29/21 lot # 32030BD;  Pfizer 7/29/22 lot# FP7150
Client was vaccinated with J&J vaccine for Covid on 5/27/2021.  Developed symptoms of Covid on 8/22/2021: cough, nasal congestion, runny nose, sore throat.  Tested positive PCR on 8/28.  Reported as a breakthrough Covid case in a fully vaccinated person.
Around 10:30am patient C/O feeling hot, flushed, dizzy and stated she felt as if she was having flu-like symptoms. VS = Alert &Oriented, B/P 120/75, Pulse OX 99% ,HR ranged between 90-162. HR later decrease to 76.  Cold compresses applied to core area of patient's body while sitting in chair. Then patient continued to c/o of dizziness and  laid down on her lefts-side onto cot. Patient monitored until 11am and stated she was feeling better.. Patient released to husband and staff took her out in wheelchair  to his car.
Mom called 2/18/16 to say that patient had redness, hard swollen right and left arm where injections were given KINRIX given (L) deltoid PROQUAD (R) arm. She stated she called dr and they told her to give BENADRYL and apply cool compresses and if not any better by Friday 2/19/16 - MD office to see pt. Mom states patient gets "cellulitis with mosquito bites was not told of this during visit. Mom to call DOH of any action taken.
9:15 am client reported to have lightheadedness and nausea. Also reported has high anxiety and is on Prozac. MD on site evaluated client. Vitals done and was observed for 30 minutes. No further complications and client then drove home.
pt recv vax;to er w/ redness,hardness&pain at inject site;2" area around inject site was red,hard&tender;abscess secondary to an infected hematoma dx;given meds;
I felt like my throat was getting a little "thick" while sitting there so stayed for 35 minutes.  I did not say anything.  I went home and within 1 hour after the shot my ears seemed get clogged and itchy.  My upper lip swelled up enough for me to feel it and notice while looking in the mirror then my throat seemed to get thick. I did not have difficulty breathing.  I drank  a lot of ice cold water and took a benadryl which seemed to halt the symptoms.  I woke up the next day and all seemed to be better.
General dragged out malaise; Cold; had a fever of 101.1 degrees F; Dragged/tired out for 4-5 days; No energy; Sleeping later than used to; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), INITIAL INSOMNIA (Sleeping later than used to), MALAISE (General dragged out malaise), NASOPHARYNGITIS (Cold) and FATIGUE (Dragged/tired out for 4-5 days) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (No energy), INITIAL INSOMNIA (Sleeping later than used to) and FATIGUE (Dragged/tired out for 4-5 days). On an unknown date, the patient experienced MALAISE (General dragged out malaise), NASOPHARYNGITIS (Cold) and PYREXIA (had a fever of 101.1 degrees F). At the time of the report, ASTHENIA (No energy), INITIAL INSOMNIA (Sleeping later than used to), MALAISE (General dragged out malaise), NASOPHARYNGITIS (Cold) and FATIGUE (Dragged/tired out for 4-5 days) outcome was unknown and PYREXIA (had a fever of 101.1 degrees F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      No Relevant concomitant medications was reported.  Treatment information was not provided; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149581:
Pt started expeircing dizziness since last night (11 hrs following vaccination) with no other symptoms. She describes the dizziness as severe but not constant throughout the day. Pt has no other symptoms at this time.
18 y/o M went to Clinic this morning & Provider contacted clinic for eval of SM's (2) new pustular lesions forming below and medial to central SPV Jennerian Pustule on left upper arm. SM received his primary SPV (LUE) on 18JUL11. He also received AVA #1, TYPHIM Vi and Hep B #1 (all in RUE) at the same time. No hives, facial edema, lip swelling, eye swelling, breathing difficulty or swallowing difficulty during 1st 15 minutes s/p receipt of vaccines mentioned or in first 3 hours s/p vaccination. No unusual symptoms until 26JUL11 (Day #8 s/p imm), when the SM noticed another small pustule had appeared beneath the central Jennerian Pustule on his LUE. SM reports feelings chills (T 99.6F), nausea, stomach ache and general body ache. He did not take any OTC Ibuprofen or TYLENOL for symptom relief. He noticed a second pustule forming medially next to his central Jennerian Pustule the next day (27JUL11). He continues to feel some generalized body ache, but no longer feels nauseous. He denies any chest pain or SOB, no pain radiating from chest to neck, throat, or left arm. He has been using an occlusive square bandage over his SPV site, not permitting air circulation. (2) "Satellite lesions" -> from vaccinia drainage on bandage.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 12:30 pm. 35 minutes after receiving the vaccine individual developed  flushed on face and chest. She was given Benadryl 50 mg IM in Right arm at 1:20 pm. 1:45  the flushed skin was less intensified and vitals were stable. Individual went home with family
I once had a similar episode many years ago so I did not relate it to the vaccine at all. Then I laid down to go to bed and I got extreme vertigo. The room was spinning. I was sort of ok the next day. Then it happened again later in the day, through the night, and the next day. I was feeling off balanced and nauseated. They recommended me a maneuver to do, I tried that maneuver. It did not help. It made me start vomiting, I could not stop vomited. For the next 2 days I was not able to sleep or take in much fluid because of the nausea. That was when I went to the emergency room. I had a severe headache by that time. They did a CAT scan, EKG, and blood work, which came back normal. They  gave me nausea medication. They discharged me. I did not feel great but I was feeling better. I could eat now. I had a low grade fever after coming home. I was concerned because I live with someone who has an immune condition. I took a Covid test and it was negative.
8-27-08 - Call from family - Had shots yesterday - Now area is red, swollen, hot to touch. Headache last night and today; Left arm; Ice/Tylenol
I had my first shot on July 26, 2021, and I had minimal adverse effects after that one, but I did have some headaches for the next couple of weeks that were out of the ordinary.  A few days after the second shot on August 25th, 2021, on August 28th in the evening, I started getting a headache that progressively got worse and the next day it had gotten so bad that I could not do anything but lay in the bed with the lights off.  It hurt so bad that I threw  up 3 times and my husband then had to take me to the emergency room to try to get rid of it.
Father calls states that patient woke up this morning with a swollen face. No breathing or swallowing difficulties. Father gave her BENADRYL. Health Dept nurse instructs him to take her to her doctor.
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On 04-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N031001 and expiration date 03-NOV-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
aches; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 17Oct2023 at 06:00, outcome "recovering", described as "aches"; PYREXIA (non-serious) with onset 17Oct2023 at 06:00, outcome "recovering", described as "mild fever". Therapeutic measures were not taken as a result of pain, pyrexia.  Addiitional information: Pfizer suspect drug dose number: 4. There was no covid prior vaccination, no covid tested post vaccination. There was no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
TACHYCARDIA (SUPRAVENTRICULAR); AIR BUBBLE IN THE CHEST; This spontaneous report received from a consumer or other non-health professional (Johnson and Johnson) concerned a 52 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: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 21-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 21-JUL-2021, the patient began complaining if episodes of tachycardia (supraventricular) that have prompted admission to the hospital at least half a dozen of times ever since. The patient had also complained of having an air bubble in the chest on 21-JUL-2021. The patient was hospitalized on 21-JUL-2021 and it was not reported if the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia (supraventricular) and air bubble in the chest. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220533119-Covid-19 vaccine ad26.cov2.s. tachycardia (supraventricular), air bubble in the chest.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
On Friday, 3 days following the vaccination, patient developed rash which was itchy and irritating on the site of injection. Site compressed with ice. By Friday night rash reduced and by Saturday, the rash was much less and by Sunday it resolved.
Patient fainted after standing up.  Immediately came to, Bp was 146/76. Gave water, pt sat with feet up. After 35 minutes felt better, bp now 121/85. Pt left with father.
Eye swelling started the night after receiving the vaccine.  It was more prominent the next morning.  Was seen in our office 11-8-21
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 at 10:00 as dose 6 (booster), single (Lot number: GJ3268) at the age of 73 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 14Aug2023 to 19Aug2023 for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285705 same patient, different drug/event;
I have diarrhea; I've been very tired since I had it; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I have diarrhea) and FATIGUE (I've been very tired since I had it) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot: 026D21A and lot: 013M20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, LOSARTAN, MIRTAZAPINE (MIRTAZAPIN) and LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced FATIGUE (I've been very tired since I had it). On an unknown date, the patient experienced DIARRHOEA (I have diarrhea). At the time of the report, DIARRHOEA (I have diarrhea) and FATIGUE (I've been very tired since I had it) outcome was unknown.            No concomitant medications were reported No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received, contact details(email) updated. On 04-Nov-2021: Follow up received, contains no new information.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 11-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 VACCINATION COMPLICATION (Side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported after 1st dose vaccination    This case was linked to MOD-2021-044883 (Patient Link).