chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 21 year old daughter with penicillin allergy and allergy to codeine who in March 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included YAZ. After receiving the first dose, she had itching and redness at the injection site and developed patches on her back and hips that were the size of a baseball and were purple on the outside and white on the inside, and her skin is very hard. The consumer reported that her daughter saw the physician at school for about two months and they could not figure out what it was so they had then sent her to a dermatologist, in which they did a biopsy and could not figure out what the patches were. In June 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). About two weeks later she had developed about eleven new patches on her breast, back, hips and other spots as well. The consumer reported that her daughter then came home from school and saw her own primary care physician who sent her to a dermatologist. The dermatologist as soon as she saw her daughter diagnosed her on site with localized morphea acleroderma, which is a build up of collagen that attacks the skin. The dermatologist also did a blood test, and first prescribed a topical steroid, name and manufacturer unspecified, which made some difference, but then was put up on prednisone for a month which had helped, and her daughter stated that "you can hardly see the patches but they are still there." The consumer also reported that "While taking prednisone, she lost about 5 pounds, even though she was eating normally, and she was having problems with her stomach and bladder. The patient has seen a physician about this and was tested for diabetes and bladder issues, but she did not have any and the physician feels it is from the prednisone. No further information is available.
79 yo male resident of nursing Home, tested pos for Covid 1/3, sent to ER for dyspnea
Local reaction of right deltoid area - noted right upper arm was warm, red, and tender to touch the day after she received her vaccines; no decreased ROM; no lymph adenopathy. Symptoms got worse over the last few days. On 11/17/03, induration 30x40mm. No systemic symptoms like fever, chills, headaches or generalized muscle aches. Self treated with Benadryl topical. Recommended nonsedating antihistamine, NSAID, and Rx-strength topical.
temp max 102.6 24 hr after vaccine. Low grade temps to 100.7 daily for 7 days. Worst symptom: severe insomnia days 3 thru 7.
About an hour after I received the HPV vaccine and Hep B vaccine administered at the same time together, I started getting twitching in my legs and calves. It soon spread to my arms and other areas of my body. Then months later, I started getting digestive problems that I'd never had before. I have seen various doctors and no one can figure it out as of yet.
red rash in the arm that's getting larger/ Larger rash 3-1/2 x 2-1/2 inches; darker red circle; hypersensvity reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (red rash in the arm that's getting larger/ Larger rash 3-1/2 x 2-1/2 inches), VACCINATION SITE ERYTHEMA (darker red circle) and HYPERSENSITIVITY (hypersensvity reaction) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy, Urinary tract infection (had for years), Blood pressure high, Tremor (essential tremor voicebox) in 2012, Osteoarthritis and Osteopenia. Concurrent medical conditions included Allergy to antibiotic (Experienced Hives) since 2002, Hives, Hay fever and House dust mite allergy. Concomitant products included DILTIAZEM from 15-Mar-2017 to an unknown date for Hypertension, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ZINC for Supplementation therapy, ASCORBIC ACID, OLIGOMERIC PROANTHOCYANIDIN, VACCINIUM MACROCARPON (CRANBERRY) for UTI, ESTRADIOL (ESTRACE), MULTIVITAMIN [VITAMINS NOS] and METHYLCELLULOSE (CITRUCEL) for an unknown indication.    On 02-Jan-2021 at 7:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (red rash in the arm that's getting larger/ Larger rash 3-1/2 x 2-1/2 inches), VACCINATION SITE ERYTHEMA (darker red circle) and HYPERSENSITIVITY (hypersensvity reaction). The patient was treated with HYDROCORTISONE for Rash, at a dose of UNK dosage form. On 21-Jan-2021, VACCINATION SITE RASH (red rash in the arm that's getting larger/ Larger rash 3-1/2 x 2-1/2 inches), VACCINATION SITE ERYTHEMA (darker red circle) and HYPERSENSITIVITY (hypersensvity reaction) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitants includes multivitamins for immunity and methylcellulose +vitamin D3 for an unknown indication. On 18-JAN-2021, patient went to physician and he said it was a localized reaction to Moderna vaccine. It was reported that no medicine required as it was not infected.   This case was linked to MOD-2021-214543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information received medical history, concomitant medications and outcome of the event was updated. On 08-Jun-2021: Follow-up information received captured medical history, concomitant medications, event and outcome updated.
Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored M-M-R II (incorrect product storage) (lot # L015279, expiration date 30-APR-2017, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Patient received her 2nd dose of Pfizer; Left arm.  Pt reported to observation nurse she was experiencing "itching" on her legs.  Patients daughter was instructed to pull to the side for further assessment.  Pt A + O x 3, denies chest tightness, SOB, or Swelling not on assessment.  No raised bumps/rash noted on legs.  VS 139/70, P. 75. R. 20  Benadryl PO 5 ML solution was administer at 1340.  Pt provided with bottled water to sip and was monitored for an additional 30 minutes to ensure medication effectiveness and safety.  Educated on when to call 911/EMS and information provided.
Attendee received second dose Pfizer vaccine at 12:35. Lot# EW0179. Attendee was directed to observation area.   At 12:50 attendee attempted to stand and started to fall, patient was able to catch her and assist her back to the seated position.  Attendee's skin was cool and clammy.  Attendee's respirations were not tachypneic or dyspneic. Attendee was then assisted to the cot to lie down, with her legs elevated.  HR:  83   BP:  106/80   RR:   16   O2Sat%:  97      12:55 - Attendee stated she felt better, no longer clammy or pale.  Sat up in the cot. 13:10 -No voiced complaints- skin warm and dry.  Took another set of vital signs before discharge without documentation.  Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with her friend. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
Moderna COVID-10 Vaccine EUA Dec 17:  Migraine type headache centered around eyes.  Need to urinate every half hour to hour causing dehydration.  Upset stomach.  Extremely tired.  Drank as much water as I could hold which of course increased trips to the bathroom.  Unable to focus eyes. Dec 18:  Situation improving.  Able to eat.  Headache reduced to very heavy pressure around eyes.  Sight returned to normal.  Trips to bathroom down to once every 2 hours.
Patient received a 3rd dose of the shingrix vaccine even though patient had already gotten the two dose series in 2020-2021. This was discovered on date of report and patient has had no adverse affects.
Facial swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 4th February 2022, the patient received Shingrix. On 4th February 2022, 15 min after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional information was provided as follows: The reporter was a Doctor of Pharmacy. The patient received Shingrix about fifteen minutes prior to the reporting call and experienced facial swelling at the time of reporting.  Outside phone number was given for future reference and warm transfer provided. The reporter consent to follow up.
Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Six months ago I had my second Pfizer/both received a half dose booster of your Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Six months ago I had my second Pfizer) in May 2021.    On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna). On 10-Oct-2021, INCORRECT DOSE ADMINISTERED (Six months ago I had my second Pfizer/both received a half dose booster of your Moderna) had resolved.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-348882 (Patient Link).
Started with short staring spell once a day for 4 days on the 5th day she rolled to the right went limp and unresponsive for 30 sec, this began happening every hour on the hour once we were in ER and admitted to the hospital for weeks which turned into months of in and out of the hospital.
The day after Pneumonia shot, I awoke at about 2 a.m. with cold sweats, somewhat delirious, nauseous. The next morning, the call doctor directed me to ER. My arm was swollen from shoulder to elbow, red rash, and pain.
Starting yesterday (May 18th, around 8PM EST) my arm at the injection site became hot, red, very swollen/hard and extremely itchy. The size of the reaction has grown quite a bit since yesterday. My arm is quite noticeably swollen, hot to the touch and itchy. The area affected is easily larger than a half dollar.
Dtap administered 9/18/06, on 9/20/06 mother called and reported arm was swollen, hard, hot, exceeding any previous reaction.
Had Moderna vaccine on Dec, 30, 2020. starting 1/5/202 feeling lightheaded, blood pressure high, chills off and on, no fever,  redness at the site of the shot.
This subject is a 82 year old male who died from a choking episode while enrolled in RSV 11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/31/2002. The subject died 353 days post immunization on 10/19/03. The subject choked on some food and 911 was called. Subject was taken to the hospital and pronounced dead on arrival. The subject's death was reported by the Investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received on 11/3/03: Diagnosis: Cardiac arrest. According to discharge summary, pt was gasping for air more than choking. When intubated by the paramedics they did not see any food obstructing his airway. Resuscitation attempted in ER, but arrived there pulseless and remained pulseless. Family reported pt complained of intermittent chest pain over the past week. Etiology suspected arrythmia related. Cause of death: Cardiac arrest/pulseless electrical activity/idioventricular rhythm. Additional documents available with source file: ER note: 10/19/2003.
One month after my second dose I have started to have nerve pain in the immediate area around the injection site. This area had been pain free since about one week after the second shot.  As of now the pain is ongoing. It got worse for about 2 days and has remained the same since without improvement.  The pain is manageable and not bad enough that I feel need of medication. But I am concerned about it and wondering if others are reporting similar events, and if so, what is a common recovery timeline.
SEVERE  PAINFUL AND PRURITIC RASH INVOLVING FACE HEAD NECK EYE ARMS LEGS AND TRUNK.  INITIALLY TREATED AS SHINGLES WITH VALACYCLOVIR AND PREDNISONE BUT DID NOT RESPOND NOW HAS SEEN MULTIPLE PHYSICIANS AND IS ON MEDROL AND ANTIHISTAMINES.    ED VISIT 10/3/2021
Parent registered child using online registration system that included parental consent.  7am day of clinic, clinic roster printed. Child on roster as registered and parental consent received.  Child bused into clinic location from school.  Child administered vaccine.  Discovered that after 7am roster had been printed, parent had cancelled the appointment.
3rd dose of Moderna not given 6 months after 2nd dose. 2nd dose given 3/20/21, 3rd dose given 9/2/21. No adverse events reports to this Health Department
HEADACHE; NAUSEA; LIGHT HEADEDNESS; SHORTNESS OF BREATH; BODY ACHES; LEG ACHES; FEVER; BACK ACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient did not have any relevant medical history. patient had no known drug allergies. patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 201A21A expiry: 20-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced back ache. On 03-JUN-2021, the subject experienced shortness of breath. On 03-JUN-2021, the subject experienced body aches. On 03-JUN-2021, the subject experienced leg aches. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced muscle aches. On 04-JUN-2021, the subject experienced light headedness. On 04-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, back ache, leg aches, light headedness, shortness of breath, headache, muscle aches, body aches, and nausea. This report was non-serious.
First - hallucination - almost like a massive dosage of Valium. Then headache, fever and chills. Body aches overnight. Extreme fatigue and bedridden for two days following shot.
Approximately 2 weeks after the Codid vaccination I experienced frequent tinnitus in both ears.  The frequency is now CONSTANT and the intensity is causing sleep and ability to concentrate issues
Patient received Pfizer vaccines on 1/22/21 and 2/24/21. He tested negative for covid19 on 4/1/21. He presented to the hospital at Hospital on 5/25/21 for generalized weakness, fatigue, lethargy, N/V, fever/chills. He had first developed nausea/vomiting on the morning of 5/24/21. He was then hospitalized on 5/25/21 and tested positive for covid19 on 5/25/21.
I experienced tiredness. My skin was itchy and I developed a rash. In May 2022, the rash spread all over my body and became worse. I got a biopsy done in December 2022 and I was diagnosed with Eczema. I now take two shots of Dupixent.
THE LESION IS .25 CM IN SIZE. SHAPE IS ROUND. VESICLE ARRANGEMENT IS GROUPED, AND HAS A FOCAL DISTRIBUTION.  ADDITIONAL SURROUNDING ERYTHEMA, INDURATION, AND WARMTH, NOT SPREADING.  START BACTROBAN NOW, BENADRYL IF NEEDED, DURACEF IF WORSENS, AFFECTED SITE OUTLINED.
None at the time of vaccination.   Pt admitted to ER on 2/25 with chest pain.
Skin burning and stinging on the left side of my body going from the top of my head down my arm and back.  Some nausea, some loss of appetite.  My blood pressure has increased by 30-40 points.  I am not feeling 100%.
My lymph nodes under my left arm have swollen to size of an large orange. Hurts to lift or shift my arm
11/20 -> Patient woke up feeling like legs were very weak & stiff. He could not walk and had chills throughout the day. 11/21 -> Patient contemplated on visiting the ER. If he stood up he felt like he needed to keep moving.
Showed signs of fatigue and began running a fever. Fever was 102.3 that evening and the next morning. Rash began showing on face evening of 2/18/15.  Rash spread to torso, arms and legs by end of day 2/19/15. Gave lukewarm bath and Motrin to reduce fever.  Fever was gone by AM Fri 2/20. Rash still present and worsened on face by Sun 2/22.  Mon 2/23, Rash was lighter in color and mostly faded on torso and legs.  Visited Dr to show her the rash.  Still mild rash on face as of 2/24 and very light on torso, arms & legs.  Also during this time experienced decrease in appetite.
This case was reported by a physician via a GSK representative, and described the occurrence of bloody diarrhea in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). The subject's medical history included bloody diarrhea and cow milk protein allergy. The subject had experienced bloody diarrhea and possibly decreased bicarbonate and acidosis after the 1st dose of ROTARIX (see case A0784664A for more details). On an unspecified date the subject received 2nd dose of ROTARIX (1 ml, oral). At an unspecified time after vaccination with ROTARIX, the subject experienced bloody diarrhea. The subject also experienced decreased bicarbonate (11-12, unspecified units) and acidosis after a least one dose of ROTARIX. It was unclear whether the subject experienced decreased bicarbonate and acidosis after the 1st dose, 2nd dose or both doses. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. There was no further information at the time of reporting.
Pediarix given  4/7/23, minimum valid date for Hep B component was 4/12/23. administered too early.  No current adverse events noted.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.  On 11-Jan-2021, Excursion time was 2 PM, temp was 35 ,condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was stored on cooler 1 , on 11-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 37, 11 AM:37, 12 AM:35, 1PM : 36, 2 PM : 37, 3 PM: 37.  Vials only punctured right before administration  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment details was not reported by the reporter   This case was linked to MOD-2022-566976 (Patient Link).
Subject reported on 12/11/08 what sounds to be a hematoma.  He described red, itchy, swollen, hot, localized reaction at injection site.  Her physician recommended BENADRYL.  1 recommended pt also take IBUPROFEN and apply ice.
Patient received her a flu vaccine in the left deltoid area.  After receiving the flu vaccine patient complained of an extreme sharp pain in her arm at the area of injection.  Then later felt nerve related pain in her arm that traveled through her upper back/neck then eventually to the opposite arm. Her pain later turned to numbness in both arms and neck and has remained for 1 week with accompanying muscle spasms and numbness from left to right side of her upper back.  No specific error in injection technique was described by either the intern or the patient during the administration of the flu vaccine.
s/sx nausea, vomiting, SOB, swollen upper lip; seen by MD; pt given Proventil syrup for asthmatic attacks; MD stated that attack was probably vax related;