chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large localized reaction left anterior thigh. Vaccine unknown patient seen in ER for recheck after shot. Clinically child leaked ok except leg rash /swelling.
Tuesday 12/7 - Symptoms started with stomach issues, body aches, and fatigue.  Slept for 11 hours Wed  12/8 - Stomach issues, body aches and headachey throughout the day.   Still feeling fatigued. Took Tylenol and it heped the body aches and headache but symptoms return when Tylenol wears off.  Stomach issues and headache are constant. Thursday 12/9 - Stomach issues and headache are constant.  Still fatigued. Took Tylenol but the symptoms return when Tylenol wears off Friday 12/10 - Stomach issues, headache, and fatigue is very bad. this morning  Could not drive my daughter to school.  Rested and took Advil. Headache, fatigue, and stomach issues continue.
Headache, Fever, Syncope, RIGHT UPPER ARM SWELLING Narrative: 1/31/21 Syncope event 2/2/21 ER visit
Rash in joints (knees, elbows, ankles) red, inflammed and itchy.
Varicella vaccination was administered via route intramuscularly instead of sub-1. Mother notified.
the patient definitely did not receive a full dose; the patient definitely did not receive a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose) and NO ADVERSE EVENT (the patient definitely did not receive a full dose) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was reported.     On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (the patient definitely did not receive a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose) and NO ADVERSE EVENT (the patient definitely did not receive a full dose) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (the patient definitely did not receive a full dose) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose).    No concomitant and treatment medication information was reported.   Reporter did not allow further contact
Quarter sized raised red area at injection site that is warm to touch.  It has gradually grown over the day.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-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 22-Jun-2021 at 9:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 9:37 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 19.30.  Concomitant medication of the patient was not reported.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature of 35 degrees Fahrenheit at 08:00 AM. These vials were moved to fridge on 27-May-2021 and beyond use date for the vials was reported as 26-Jun-2021. The vaccines moved to clinic on 22-Jun-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
JUST TENDER; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and just tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and just tender was not reported. This report was non-serious. This case, involving the same patient is linked to 20220112632. This case, from the same reporter is linked to 20220112654 and 20220112293.
Local reaction 3 x 3 cm red, rash, not warm, not indurated, not painful.  Treated with Benadryl.
Developed a rash, hotness of skin, itchy throat and felt a racing heatbeat approximately 1.5 hours after injection.    Follow up with urgent care immediately following and was given a 50 mg. Benadril injection for an allergic reaction.
redness & swelling in inject area (approx 2 cm in diameter); cool compress & DPH;
late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2022 ).   In MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 A pharmacist reported that a patient received the 1st dose of Shingrix in March 2022 and a late 2nd dose in May 2023 which led to lengthening of vaccination schedule. The vaccine administration facility is the same as primary reporter. The health care professional did not have the exact date of vaccination or lot number or expiration details.  The reporter consented to follow up via email.
5-29-13 - Day - Fever 101.0. That night Mom noticed (R) arm was swollen and red, with red lines coming away from injection site. No c/o's pain. 5-30-12 Instructed to go to ED. No fever. Symptoms same. Mom states that ED stated "It was something with his immune something...possibly an infection. Placed on 2 antibiotics: BACTRIM and Cephalexin. 6-4-13 Follow up. Mom states "He is way better". States he has finished his antibiotics".
patient was vaccinated with an expired Havrix dose.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 22nd December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 23-DEC-2022 Reporters comment: The reporter reported that patient was vaccinated with an expired Havrix dose. The vaccine administration facility was the same as primary reporter The reporter consent to follow-up via email. Additional Supportive information: The patient was vaccinated with an expired Havrix dose, which led to expired vaccine used.
After 10 days of the first shot (first dose acquired on March 9) a lump appeared in the clavicular area. After the second dose, Loris had all the effects expected of the vaccine after 7-10 hours, and the lump got bigger and more sensible.
?Moderna COVID-19 Vaccine EUA? Fatigue; Fever; Chills; body and muscle aches; Headache
Patient reported to the pharmacy 2 days post-vaccine with an overly red rash approx 3" in diameter at the vaccination area. Patient reported pain and having trouble sleeping the night before.
Diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender reported that the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: the number was 19289, it was EW0196 (as reported), Expiry Date: Unknown), via an unspecified route of administration on 12Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jul2021, after the patient took the shot, the patient had diarrhea. The outcome of event was unknown.   Information about lot and batch number was requested.
I have fever for 5 days, body ache I got body ache that lasted 24 hours, and after that I for pain for 5 days, Beginning of June I got heart palpitations.  Oct 1, 1 I got blood test then I saw the doctor in November, I was diagnosed with hyperthyroidism in Propranolol & Methimazole. They take my blood every month.
MY CHILD HAS BEEN HAVING FEVER, COUGH, HEADACHE, LOSS OF APPETITE, LOOKS PALE, CRIES EVERY NOW AND THEN, AND NOT AS ACTIVE AS HE USED TO BE. HIS TEMPERATURE HAS REFUSED TO COME DOWN. HE HAS NEVER BEEN LIKE THIS SINCE HIS BIRTH. WE HAVE NO HEALTH INSURANCE AND HAVE NOT BEEN ABLE TO TAKE HIM TO SEE THE DOCTOR. WE HAVE BEEN GIVING HIM TYLENOL, BUT NO PROGRESS.
Initial report received on 19 October 2009 from a health care professional. A 35 year old female patient with seasonal allergies reported that her eyes became swollen, she developed a sore throat which felt swollen, began coughing, and her face was flushed within 2 hours of receiving an initial dose of FLUZONE (lot number U3200AA) intramuscularly in the right deltoid on 16 October 2009 at 2:00 PM. The patient took an oral dose of BENADRYL. The patient's spouse took the patient to an urgent care clinic. The patient was treated with BENADRYL, epinephrine, and SOLUMEDROL. Following the appointment, the patient returned to work. The patient recovered. This reporter is the same as case number 2009-04395. 12/1/09 Medical records received for date 10/14/09. DX: systemic reaction to influenza vaccine. Pt presented w/ c/o receiving flu vax and within 1/2hr experienced itching bilat eyes, lump in throat, heart racing, wheezing, eye drainage. Currently at clinic pt states sx worse, diff. swallowing, throat swelling. Assessment: prolonged expiratory phase, sclera are markedly injected, eye drainage noted. Pt tx for vax reaction, pt. became stable before leaving clinic.
My head felt "funny" like I might fall out of my chair, within 5 min after vax. After being home, pt experienced aching in extremities & by early evening, temp was 101.
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
pain in the arm a little bit over the elbow.no brusing , swelling or redness. no fever
Severe headache and dizziness that has not cleared and has impacted ability to focus on reading, tasks, etc.  without extreme headache.  Being treated for headache with rest and today starting a short course of steroids.  Also, nightmares and insomnia continuing since vaccine administration.
Chills with shaking and teeth chattering for two hours; fever of 100.5; headache; body aches; nauseous, having to use the restroom often.
11/06/2022  I was on the plane and I started feeling nauseated, headache , feverish and achy.  I continued to feel worse.  When I got home that evening, I took a Home COVID test that was positive.  I took Motrin for the fever and aches.  I called my doctor the next day to get advice.  He told me to isolate and gave me a testing schedule and to call if symptoms worsen. They did not. By 11/9/22 and 11/10/22, I started feeling better. It slowly got better and better. I tested negative on 11/16/22.  I felt I had recovered by 11/18/22.  On 11/28/22 I began feeling achy, nauseated and felt like I had the flu.  11/29/22, I called the doctor and he prescribed Zofran. I took 2 doses and that really helped a lot.  Day be day, I started feeling better. The fluid I was able to get into my system helped.  By 12/3/22, I feel like I had recovered.
This spontaneous report as received from a registered nurse refers to a 13 month old patient. On 14-NOV-2013 the patient was received with a first dose of VARIVAX (Merck) (injection, strength, lot#, dose, route and duration were unspecified) and PROQUAD (formulation, strength, lot#, dose, route and duration were unspecified). No adverse symptoms reported. Patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
burning; bruise at the site of injection; experienced a little bit of a sore arm, body aches and chills; experienced a little bit of a sore arm, body aches and chills; experienced a little bit of a sore arm, body aches and chills; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 (at the age of 36-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included internal shingles. The patient's concomitant medications were not reported. The patient previously took miralax and experienced Hives. On 26Mar2021, the patient experienced a little bit of a sore arm, body aches and chills, on an unspecified date, patient experienced burning, bruise at the site of injection. Symptoms began 5-6 hours after injection. It was reported that forearm pain and burning remains now 6 days later and appears to be worse in last 24 hrs. The outcomes of events (experienced a little bit of a sore arm, body aches and chills) were recovered next morning on 27Mar2021 and the outcomes of events (burning, bruise at the site of injection) were unknown.  No follow-up attempts needed. No further information is expected.
Lot was expired, expired 3/10/2020 and provider ordered Hepatitis B vaccine.  Called patient to inform, no tenderness or other s/s noted.  Will provide Hepatitis B vaccination next week.
Tightness in chest.  Shortness of breath.  Sore jaw. Pain in left arm.  Called 911 and paramedic took EKG and informed me I was having a heart attack on the way to the hospital.  Once at the hospital they measured my TnT-Gen5 and the baseline was 2658 ng/L with another test taken an hour later showing 2873 ng/L which led to additional tests listed in box 19.  Final diagnosis was perimyocarditis and I received a prescription of Colchicine 0.6 MG to be taken twice a day for 6 weeks and then follow up with a cardiologist.
admission date 2/27 There is no acute sign at this time.  He did screen positive for COVID-19.  There is no symptoms of pneumonia or other complicated illness from infection at this time.  He will proceed to the medical ICU for further management.  dose 3 (pfizier)  given 9/28/2021
Tingling of lower legs; Rash on lower leg; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg). At the time of the report, PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M037248, expiration date 21-FEB-2019, for prophylaxis. Other suspect therapies included GARDASIL 9 lot # N002720, expiration date 12-MAY-2019, for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event.
Severe shoulder pain for several months. Took months of physical therapy and Cortisone shot to relieve pain.
Approximately 9 days after first COVID vaccine patient noted "red, itchy ring" around the site of injection. Symptoms resolved with 48 hours.  Received her 2nd vaccine 02/24/2021 with no issues.
Day of vaccine my arm was sore  and I had a slight headache and my heart rate felt fast but I think my heart rate was due to anxiety about the vaccine .  That was until Friday morning. I woke up on the 5th at around 1 am shaking . Then got the cold sweats and chills and then burning up and body aching.  Then I started throwing up.    I started taking  some IBProfen  which helped with the fever and shakes.   Stayed in bed all day and drank water.    My heart rate was up to 122 bpm while I was laying on the couch.  I was tracking it with my Apple Watch.  I stayed on the couch for the next 2 days and Sunday I started feeling better.   Each day I was feeling better but now almost two weeks out I still get slight headaches off and on,  I have no energy and get the chills and my chest has a heavy feeling.  But I don?t feel short of breath.  I took a rapid covid test today 3/15/21 and the results were negative for covid and the flu.  I am going to see a doctor on wed.  as I am not sure I should get the second dose.
I received my second dose of my moderna COVID-19 vaccine on Sunday, May 9th. On May 13th around 2:40 pm, I began to experience a full sensation in my right ear. My hearing felt slightly muffled, with mild ringing. It has been 5 days since my symptoms started. On May 17th I went to my primary care provider and was told I had redness and inflammation inside my ear. I was prescribed sterile otic suspension drops of Ciprofloxacin 0.3 % and Dexamethasone 0.1% for use of 7 days. This is my second day of treatment, however I feel the same.
Pt was given DTaP instead of Tdap. No symptoms within 24 hours.
This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is patient. A 43-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), on 25Jan2021 as dose 2, single (Lot number: EL8982) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Dysthymia" (unspecified if ongoing). Concomitant medication(s) included: Rosuvastatin; Escitalopram. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Negative, notes: asymptomatic; (22Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Other medication was received in 2 weeks. Rebound COVID: tested negative 16Aug2022 and was asymptomatic; tested positive 22Aug2022 with mild congestion and fatigue. Device date was 22Aug2022. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Immediately after giving the vaccine, the medical assistant noticed the patient started blinking a lot, then tried talking to the patient, who was not responding in the usual manner. The patient suddenly could not state her last name or identify the date, her location, or any other information. This was a complete change from prior to giving the vaccine. A medical alert was called; 911 called. Patient was transferred to the emergency department.
33 YO F NOT VACCINATED; NON-ITCHY RASH; NO HISTORY OF CONTACT WITH VACINEES; FINAL DX: RASH NOT ASSOCIATED WITH VACCINIA.
4 hours after my daughter got her shots her fever wouldn't go down. At 11pm that night she begain to have complex febrial seizures. She had 3 that night. After coming home she wasn't the same. One of her eyes didn't open as much as it should have and she was slower. Almost a month later she died in her sleep because of another febrial seizure.
PATIENT RECEIVED 3RD DOSE OF PFIZER IN RIGHT ARM ON 10/08/21. PATIENT REPORTED TO PHARMACY ON 10/26/21 STATING STARTING 10/21/21 OR 10/22/21 HE NOTICED A BUMP AND RASH STARTING TO FORM AT THE INJECTION SITE AREA. PATIENT IS NOT EXPERIENCING ANY OTHER SYMPTOMS AND REPORTED HE DID NOT EXPERIENCE ANY SYMPTOMS WITH PREVIOUS DOSES. INFORMED PATIENT TO REPORT TO PRIMARY CARE DOCTOR AS WELL AS REPORT SYMPTOMS TO V SAFE. PATIENT AWARE I AM REPORTING SYMPTOMS TO VAERS