chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1) The right portion of my lower lip started to swell on Tuesday (Feb2) or Wednesday (Feb3); I don?t remember which day. It?s been getting a little worse every day, including today (Friday). I?ve been regularly putting petroleum jelly on my right, lower lip to relieve the discomfort. I?ve also been putting petroleum jelly all over my lower and upper lips, because both lips have become unusually dry since the swelling began.  2A) Part of my skin (near the needle?s point of entry on my arm) came off when I removed band-aid at end of my shower on Tuesday (Feb2) morning.  The narrow, skin-missing area on my arm is a little less than the size in length of the width of the band-aid that I removed. (I have a photo if you?d like to see it.) Although I turned shower water off before removing the band-aid, that raw skinless part of my arm started to sting and burn profusely, immediately after I removed band-aid. The steam (not water) from the shower stall is what burned so badly. When looking in mirror to investigate source of pain, I was puzzled as to why my skin was missing.   2B)Wednesday (Feb3) morning, my husband attempted to put Neosporin on that small portion of my skinless arm to prevent infection from setting in. But it was so painful, I had to stop him. The area burned for more than an hour. So now I keep the band-aid on that spot and don?t remove it. It?s still very sensitive, and I feel discomfort while taking a shower. But since I leave band-aid on, it doesn?t burn and sting like before. And It wasn?t until Thursday (Feb4), after looking online at missing skin, that I realized that my skin apparently came off when I removed the bandage. I also read, when looking online, that skin removal with bandages can happen more often with older folks like myself. I?m not sure if this is an adverse reaction to the vaccine or not but thought I?d report it just in case.
Red itchy dots on  stomach, back, arms and thighs. Itching has not stopped up to date. Then PCP prescribed  Triamcinolone 0.1% for itching and Mupirocin 2% for rash on ankles. It did not get better. Seen a dermatologist who conducted swab test on ankle rash and found MRSA in the test. He prescribed Doxycycline twice a day for ten days, but, no improvement after seven days of using it.
Headache thats lasted 3 days. Nausea, hot flashes, swelling/pain in arm. Stiff joints.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). It was reported that the patient did not have adverse events associated with the first dose. The second dose was given eight weeks after the first dose, an about 4 to 5 later, the patient developed an arthus reaction, cardiac palpitation and premature ventricular contraction (PVC), the patient become short of breath and was diagnosed with cardiomyopathy. It was reported that some of these symptoms may have been presented before vaccination. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches), PYREXIA (fever of 103) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Crohn's disease. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (body aches), PYREXIA (fever of 103) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body aches) and PYREXIA (fever of 103) had resolved and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 103 (High) fever of 103F. On 15-Feb-2021, Heart rate: 85 (High) elevated heart rate of 85 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Baby covered with blanket on face, not breathing. Taken to hospital Dr's thought had a seizure. Spent 1 week in hospital. On 2nd day at hospital has seizures and since then is having seizures regularly they can't be controlled with any medication. Annual followup 01/4/2010 Has seizure 10-15 aday and has now been diagnose w/ cerebral palsy. 60 day Follow-up Information 23-OCT-2006: Patient has 5 to 6 seizures a day, hes is delay, he doesn't talk, can't feed himself like a two year old, he is average like a 9 month baby. Epilepsy run in my family, I believe this vaccine trigger patient to have seizure. Before the shot, he was a healthy baby.
Information has been received from a medical assistant regarding unspecified number of patients (ages and genders not provided). Sometime in June 2017, the patients were vaccinated with PROQUAD  (lot# M037011, expiration date 21-APR-2018, lot# M044719, expiration date 07-MAY-2018) and sterile diluent (STERILE DILUENT). It was reported that the products were stored improperly. The sterile diluent was stored properly. PROQUAD were stored at 6F to 14F for 14 hours and 7 minutes. No previous temperature excursion. Data logger was yes. There were not reported symptoms. This is one of two reports received from the same reporter. Follow up information has been received from the reporting medical assistant on 14-AUG-2017. The reporter stated that patients were vaccinated with the above vaccines after the data logger excursion. She had the information packed away in a box, as her office was moving. She would fax the information in once the office moved.; Sender's Comments:  US-009507513-1707USA005085:
received Bexsero instead of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The reporter stated that the patient received Bexsero on the day of reporting instead of Engerix B.  No additional details were provided. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Bexsero instead of Engerix B, which led to wrong vaccine administered.
Probable developed occlusion of right lower extremities via type 3 immuno-complex.   Subsequently Pt underwent angiogram and amputation.
A non-serious spontaneous report of fever of 100 F, pain in legs, not feeling well and eye glossy has been received from a non-health professional concerning a four-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 09-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 12-Nov-2009, the patient developed fever of 100 F, pain in legs, was not feeling well and eyes glossy. The outcome of the event was unknown.
Rec'd 5yr IMM and Flu vaccine in office 12/18/17 at check-up. S/S began next day=erythema, edema and hot to touch; (+) Fever to 102 degree max that day. Seen in office 12/21/17 -> (RT) arm with edema/redness in a 1-2 inch band around upper arm with area SL. warmth; afebrile; denies pain. Tx with BENADRYL and to monitor.
Fatigue, fever, nausea, dizziness, flatulence, pain at site of injection
A very itchy rash started on my right elbow on March 26, 2021, exactly two weeks after my 2nd Moderna shot.  Over the next 10 days the rash spread to the whole right arm, right thigh, then left arm, left thigh, then stomach, back and neck. The rash was extremely itchy and visible.
osteoarthritis is going crazy; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis is going crazy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis is going crazy). At the time of the report, OSTEOARTHRITIS (osteoarthritis is going crazy) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
I  awoke this morning  feeling feverish.  I walked to the kitchen to take tea  and a  Curamin tablet since I had run out of Advil.. I began to feel as though I was going to vomit so walked slowly to the toilet, knelt in front, then made a quarter turn,, thinking  this would not happen, and I fainted/blacked out.  I found myself face down in front of toilet and a good bump on my right eyebrow....face turned inward. I stayed still long enough to feel safe to rise and so did.  No  more sense of vomiting, thank goodness.  Just  very very tired.  I did make oatmeal with blueberies for breakfast and ate this slowly.  Just wanted to ask if this is to be expected.  It is now four hours fifteen minutes since this happened.  As I walk carefully ,  I am trusting all will be well ...but when?
Headache lasting 12 hours Fever for 8hrs Heart palpitations for 2hrs Fatigue >12hours
pt awoke in mild distress 3AM morning p/vax;distress grew progressively worse;mid day 8OCT oral temp 103, c/o h/a, nausea, myalgia & hot/cold flashes, gen weakness of lower extremities;
This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was accidentally vaccinated with a "pediatric dose" of VAQTA (dose, route and lot # not reported), which was outside of the recommendations in the prescribing information (adult use of a child product). No adverse effect reported. Additional information has been requested.
Her period came 2 weeks ago (26Mar2021), then today; diarrhea; chills; really bad body aches; headache; injection site pain & swelling; injection site pain & swelling; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling). On 15-Apr-2021, the patient experienced POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.3 (Inconclusive) fever 99.3°F.         Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medication was not reported.   This case was linked to MOD-2021-077860 (Patient Link).
Had vaccine PREVNAR 6/15 (R) arm -> later that day developed black and blue around site and then redness then next morning around the black and blue. Went to ER. Diagnosis of cellulitis. Treatment of antibiotics with clindamycin.
Immediate dizziness, injection site became hot and painful.  Dizziness and feelings of general unwellness lasted one week, pain at injection site continues 6 years post vaccination.
Stomach ache, runny nose, cough, head congestion, 102.6 fever. Fever at night for next 5 days.
Person under the age of 18 was administered the vaccine; A spontaneous report was received from a nurse concerning a pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, person under the age of 18 was administered the vaccine.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a patient under the age of 18 was administered the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  person under the age of 18 was administered the vaccine, was considered resolved.; Reporter's Comments: This case concerns a patient  under the age of 18 years and of unknown gender.  The patient's medical history is not provided.  The event occurred on an unknown date, where the patient was administered the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Pt with PMH of hypertension and obesity has had 1-2 days of fever, dyspnea, and fatigue. He is found to be COVID-19 positive and has Afib with RVR.
Acute hypoxic respiratory failure 2/2 COVID-19 infection hospitalization leading to death
Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Aug2021 15:00 (Lot number: FC3183) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "known allergies: Yes, azithromycin". Vaccination history included: Bnt162b2 (lot number FA6780, administration time 15:00, vaccine location Right arm, dose 1, single), administration date: 28Jul2021, when the patient was 24 years old, for COVID-19 Immunisation. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), URTICARIA (non-serious) all with onset 18Aug2021 20:00, outcome "not recovered" and all described as "Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.". Therapeutic measures were not taken as a result of erythema, pruritus, urticaria.  Additional information: patient has not taken any other vaccine in four weeks. Patient has not tested covid-19 prior to vaccine and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
01/23-01/25: Paresthesias b/l arms and dorsal hands, fever to 103F, rigors, neck stiffness 01/27: Urticaria, severe swelling and erythema left foot joints 02/10: cervical spine arthritis, spasm of the left trapezius and SCM muscles. Muscle weakness 02/10-04/20: Tachycardia to 120s-130s at rest, POTS, nausea, diarrhea, 20lb weight loss 04/20-present: chronic cervical spine arthritis
nformation has been received from a RN concerning a 1st grade male student who on 07/08/99 was vacciated with the varicella virus vacciene live.In  mid December developed Chickenpox in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
Systemic: Seizure-Severe, Additional Details: pt had seizure 12 hours after the vaccine was administered and was hospitalized
within 5-10 minutes, his stomach was hurting and began to sweat profusely, clammy, very hot, got pale, plae skin and lips, eyes rolled back, fainted, weak. paramedics were called.  while waiting he began to response to touch and was given something to smell. He was given Gatorade. he then started to shiver. paramedics arrived, tested his vitals. at that time, his vitals were good. they said drop in blood pressure probably caused it.
patient received both PENTACEL and Pediarix on same day with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who received both Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and Pediarix [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] on same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine And Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Prophylactic vaccination.  On 01-Aug-2023, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine suspension for injection; Pediarix not produced by Sanofi Pasteur (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization) and received both pentacel and pediarix on same day with no reported adverse event (extra dose administered) (latency: same day).  Information on the batch number was requested.  Reportedly: The nurse reports that the patient has not required any treatment for the event; reports that the patient has not required any ER/Dr. visits.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The first 15 minutes after the shot, I felt weak and a little dizzy. An hour later, I felt dizzier and my resting heartbeat was up to 75 bpm. My heart was racing and tingling, it felt like chills inside of my body. I became weaker and my heart jumped to 90 bpm. I became pale, disoriented, and my jaw tightened. I had no respiratory issues but I had a little troubling swallowing. I met with a Teladoc doctor who said that if I didn't get better by 6pm, to go to the ER. At 5:20, things calmed down and the reaction stopped. I felt very tired.
Day p/vax got hot, burning, aching, goose egg, swelling @ vax site, felt nauseous x 3 hrs; sx improved by 48hrs p/vax;
MODERNA COVID-19 VACCINE EUA Fever, chills, body aches and pains, exhaustion, headache, nausea, upset stomach, loose movements
10/06/2001, 1500 hrs PM, first notice "Bee sting" size area on left arm. It continued to get redder and larger and very sore by that evening, saw doctor on 10/08/2001 given Antibiotics.
In March my migraines started getting worse. Who knows what caused it, it could have been stress. The migraines  were not as bad prior to the vaccine. In May I went to see my doctor and he changed my medication, Ubrelvy 1 tablet as needed,  because the medication I was taking before was not working as well anymore. And he sent my to PT because I was also having neck pain. I don't think the neck pain was a result of the vaccine it was probably sitting too long at my desk.   Yes, I have recovered from the AE's as long as I take the new medication, Ubrelvy.
4/24/16 - Redness/warmth/localized swelling/tenderness/itching noted, 4 inches in diameter. MD notified. Loratadine 10mg PO daily PRN and cool compress ordered. 4/26/16 - MD evaluated resident for other possible causes, MD felt it was an adverse reaction to PCV-13. PRN Loratadine given again. Mild improvement noted. 4/27/16 - Redness/warmth/swelling/itching as spread in a downward direction. MD notified. MD prescribed Cephalexin 500mg PO TID x7 days for possible cellulitis. Warm moist compress ordered 3x/day x7 days.
The patient experienced a low grade fever, sore throat, headache, loss of appetite, chicken pox blisters over his entire body. The patient was treated with Tylenol, fluids, Aveeno baths. The patient was seen at the physician's office on 08/13/2001.
About 10 minutes after receiving  COVID vaccine, patient reported that her throat got tight and she became dizzy.  Vital signs stable.  Patient was administered 12.5mg PO Benadryl and symptoms subsided.  Patient was able to be discharged home and asked to contact allergist for further recommendations
Patient had a sudden onset of Dizziness, followed by nausea and vomiting. Advise patient to force fluids and promethazine 25 mg was given for nausea.
In July, patient noticed Right axillary lymphadenopathy. 3 lymph nodes were enlarged and nontender. No history of wounds, injuries, infections or illness. Pt endorsed good overall health. Denied fever, weight loss, chills, night sweats.  No other lymphadenopathy noted. Patient received both Pfizer COVID19 injections in April, 3 weeks apart. Patient unsure of exact dates. Both injections were to the right deltoid.
Patient said after shot his arm got red, swollen and very hot from the shoulder to the elbow. The patient said it got to the point he could not raise his arm. He took TYLENOL and the swelling and redness has gone away but still sore on 9/24/17. No medical attention was needed.
May 24, 2022 around 10pm right eye started to water. On May 25 2022 around 9 am Right sided facial droop, pain in ear and neck, swelling and paralysis. ER visit diagnosis: Bell's palsy, was given ocular lubricant 2 drops OU bid prn for dry eye, Prednisone 20mg 3 tabs QD for 5 days, valacyclovir 1G 1 tab TID for 7 days