chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for influenza. On 03-APR-2022, the patient started experiencing symptoms of covid-19 infection and on the same day tested positive for COVID 19 using an home test. On 04-APR-2022, he went to the doctor's office and performed another antigen test at the office which also came back positive (confirmed covid-19 infection) which led to confirmed clinical vaccination failure. He was officially diagnosed with COVID 19 by his doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000224613. This case, from the same reporter is linked to 20220406100.; Sender's Comments: V0: 20220406167-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Pt has history of hypertension, did not take BP meds this morning and missed all meals. BP and O2 checked and EMS contacted. Departed with EMS.
Information has been received from a nurse practitioner concerning a roughly 22 year old female who completed the GARDASIL series (0.5ml/3 shots). The patient developed CIN 2, 3 after the series. At the report time the outcome was unknown. Follow up information was received from a nurse practitioner on 27-JUL-2009: The patient received the GARDASIL on the following dates: the first dose on 17-OCT-2008, Lot# 660557/0072X; the second dose on 12-DEC-2008, Lot# 661703/0651X; the third dose on 06-APR-2009, Lot# 661846/1312X. In November 2007 the patient's Pap smear results were atypical squamous cells of undetermined significance (ASCUS) with negative high risk. On 17-OCT-2008, the patient's Pap smear was positive for HPV. The patient received the first dose of GARDASIL on 17-OCT-2008. The patient's Colposcopy was negative. The patient was a recent converter to HPV. On 06-APR-2009, the patient's Pap smear results were ASCUS, positive for HPV. The patient had received the third dose of GARDASIL on 06-APR-2009. On 29-MAY-2009 the patient had a Colposcopy which revealed moderate dysplasia, Focal High-grade, CIN 2. On 10-JUL-2009 the patient had a LEEP Procedure, which revealed Mild dysplasia, CIN 1. The patient had a scheduled follow-up appointment for 18-Jan-2010. Additional information has been requested.
On the day after vaccination I had a rash on my right arm below the injection site.  This subsided within 24 hours.  However, a few days later I started having patches of itchy rash on different areas of my upper torso, neck, arms.  This subsides after I apply hydrocortisone cream.  These occurrences were on an almost daily basis and usually at night when I would be woken up by the itchiness.  After i apply hydrocortisone cream and take a Clariten, the itchiness subsides.  On the night of April 18 the rashes and hives covered the abdomen and then extended to my chin, groin area and upper thigh near the groin area.  Again it subsided after a while with hydrocortisone cream and Clariten.  My primary care had me schedule an appointment with a dermatologists but I really think it is an immunologist I need to see.  I am concerned that the mRNA is still active in my system and still directing my body to produce spike protein which is binding to my vascular endothelial cells and causing the rashes and hives.
Dermatographia developed ten days after booster shot. Symptoms are urticaria upon any light scratching of skin from head to toe. Urticaria is very itchy and red/inflamed with raising of the skin for at least 15 minutes after initially scratching myself. I have to take OTC Zyrtec every 24hours to keep the symptoms at bay. However, I still develop red rashes every time I scratch myself anywhere, they?re not raised and they last for about 10 minutes when I?ve recently taken the Zyrtec.
Severe tinnitus , mainly in right ear. I thought it was due to ear wax build up although the tinnitus is still present after it was cleaned out. It started the evening of the first dose and gradually got worse as time went on.
2 hours post vax, the pt developed redness and swelling in left arm. A wheal the size of a salad plate around site. Swelling continued from shoulder to elbow, 2 times the normal size of the arm. She could not tolerate any one walking by her chair due to the pain. A 15-day follow up report dated 12/27/2000 adds: Info has been received from a health professional concerning a 37 year old female wih allergies to dust mites, house dust and cockroaches who received an "allergy injection" on 10/03/2000. On 10/06/2000 the pt was vaccinated IM in the left arm with the first dose of pneumococcal vaccine 23 polyvalent (lot 635893/0690K). Two hours post-vaccination, the pt "started with problems". Approx 4 hours post-vaccination, the pt experienced a wheal the size of a salad plate and could not raise her arm above her head. The arm was red, swollen and itching. The swelling continued from the shoulder to the elbow. The arm was 2 x the normal size. This was considered a "severe reaction". It was noted the pain was so severe she could not stand to have someone walk by her chair. On 10/07/2000, the pt went to the ER and was given hydroxyzine hydrochloride (Atarax) 25 mg 06h. The pt was able to go to work on 10/10/2000, however the arm was still sore. She was able to raise her arm. The pt's experiences were considered significant medical events. No further info is available. A 15-day follow up report received 12/29/2000 adds: Follow-up was received which indicated the pt did not have a separate experience of upper arm immobility. The upper arm edema caused decreased mobility of the upper extremity. The pt was known to have a history of allergies. The pt had a full range of motion in her arm and was completely recovered. No further info is available.
Breakthrough case admission after 4 vaccines Pfizer 3/2/21 Lot# EN6198;  Pfizer 3/23/21 Lot# EN6208;  Pfizer 10/22/21 lot# FF2590;  Pfizer 8/17/22 lot# FP7137
Developed Hepatitis (NOT A,B,C).  Found on 7/24/21 by chemistry blood test.  Only symptom was "dark urine". Resolved (chemically) 1 month later
Patient experienced throat tightness after injection. No respiratory distress, rash, vomiting or diarrhea. Treatment with IM epinephrine, prednisone, diphenhydramine and Cetirizine. Patient was observed in the emergency department and was able to be discharged to home.
1.  Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce soreness. 2. Started feeling chills, muscle aches, headache and nausea around 9:00PM.  3. Began vomiting around 11:00PM, with other symptoms remaining.  Vomited about 3 separate times that evening. 4. The following day, felt chills, muscle ache, joint ache, skin pain, nausea, headache and arm pain, along with sore throat (probably caused by previous night's vomiting).  I had very low energy and did not want to eat or drink anything. I began taking Tylenol every 6-8 hours and taking Pepto Bismol as needed to address the nausea.  5. The symptoms continued, but lessened each day over the course of the next 5 days.  I anticipate symptoms will continue to reduce over the next 1-2 days, and no treatment will be needed.
VET RECEIVED PNEUMONIA SHOT 8/2/16 AND HER ARM WAS SWOLLEN, HOT, SORE TO TOUCH.
This 71 year old white  male received the Covid shot on 2/11/21    and went to the ED on 2/24/21     and was admitted  on 2/25/21 with the following diagnoses listed below. COVID-19
Patient is a 36 y/o F G1P0 who had the Moderna COVID vaccine on 3/19/21 and 4/16/21. Stating 4/6/21 she had vaginal spotting. The spotting continued intermittently. She had ultrasounds which showed  On 4/16/21, she suffered a miscarriage, when she would have been about 7w4d gestation.
Patient fainted after getting J&J covid-19 vaccine about 1:12 pm. Director called 911 for EMS to come an take patient to hospital. @1:23 EMS was placing patient on gurney to transport to hospital. During vaccine clinic, patient stated arm hurt like a ppd test. He stated "this is not good" he started to slump over and started to lean over to his left side, needed assistance to keep from falling over out of chair. He was sweating, lethargic and was not able to answer questions for a minute. He started to slowly re-gain awareness was encouraged to deep breath.  He stated that after the administering of the vaccine, he felt nauseous and really tired.  He was transported to ED.
She can not taste cumin; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: ER8736), via an unspecified route of administration, administered in arm right on 27Apr2021 at 10:10 (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no previous history of immunization with the Pfizer vaccine. Patient had no additional vaccines administered on same date. Patient did not have any other vaccine four weeks prior vaccinations. On 07May2021, patient cannot taste cumin (spice). Patient clarified that her sense of taste was not gone, can taste other things, but she cannot taste cumin.  She has not tried cumin again, however, she could still taste bunch of things. Patient took Pfizer COVID vaccine to improve her chances of life. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
I started like joint pain, in my hands and when I bend my fingers, my thumb and my two fingers and I had joint pain like my legs and in my ankles; This is a spontaneous report from a contactable consumer reported for herself. A 72-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: FA6780, Expiry date: Unknown), via an unspecified route on 14Jul2021, as a single dose for covid-19 immunization. Medical history included mitral valve prolapse and arthritis. They didn't do anything about either and she was not on any medication, they just monitor it through stress test (not clarified) for every couple of years. Concomitant medications included vitamins. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jul2021, last Thursday, about a week exactly after vaccination, patient experienced joint pain, in my hands and when she bends fingers, thumb and two fingers and she had joint pain like legs and in ankles; have some joint reaction, she was not sick and don't feel sick, but it was annoying her because she noticed a lot of joint pain and she have been taking some Tylenol (Treatment). It is bearable but it comes back after it, so it's not really taking care of problem, she was just curious that how it going to be that way, as it was hurt over the week. She has an older a little bit of arthritis (captured in history) but this seems like some new has affected her left hand like the bending of fingers and joints. Patient was just trying to figure out if she has a side effect of extra joint pain issues after the Pfizer vaccine in a week. She was just curious because she was reading a paperwork that they gave her and said that you could have some joint reaction. She just wonders if it did, the paperwork that has a list of side effects that some people might get, and she didn't get it while the week. The patient second dose of bnt162b2 was due on 04Aug2021 in the right arm for covid-19 immunization. The patient underwent lab test and procedure which included stress test (not clarified). The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Stroke; Left ventricular thrombus in his heart; This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: EW0153) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included coronary artery disease (several years ago) and had a bypass (several years ago; not ongoing). The patient's concomitant medications were not reported. It was reported that the patient had a stroke on 17Apr2021 after he formed a left ventricular thrombus in his heart in Apr2021. The patient was hospitalized for the events from 17Apr2021 to 23Apr2021 and was treated with Coumadin. The outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely for BNT162B2 vaccine  since there is no plausible mechanism implicating the subject drug to the events. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a consumer concerning her daughter who in the "end of November 2008", was vaccinated with a dose of ATTENUVAX.  After receiving ATTENUVAX, the patient developed hives and fever.  She sought physician's medical attention.  The outcome of the patient was not reported.  Follow-up information was received on 22-JAN-2009 indicating no additional information.  Follow-up information was received on 12-MAR-2009 from the mother indicating her daughter, the patient had fever after receiving ATTENUVAX.  No further information is available.
Patient  presented to ER with difficulty breathing. He received 3 days of abx and completed his azithromycin.  He has worked with PT and will use a FWW to ambulate.  ON day of discharge, he was no longer requiring O2. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Recipient was inadvertently was given 2nd dose of Moderna vaccine from a vial that had reached its beyond use date 10 days prior.
Information has been received from a physician concerning a female in her "early teens" who on an unspecified date was vaccinated with Gardasil (lot # unknown).  On an unspecified date the patient experienced swelling and redness at the injection site as well as "pain radiating down the injected arm".  Medical attention was sought.  No further information was provided.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been received from a physician concerning an 18 year old white female in her "early teens" with no illness at the time of vaccination who on 22-OCT-2007 was vaccinated with GARDASIL (lot# 659435/1265U) in the left deltoid. On 22-OCT-2007 the patient experienced swelling and redness at the injection site as well as "pain radiating down the injected arm" from the shoulder to the elbow for 1 month. The patient developed a mild rash. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered.
Patient reported burning and stinging in her hand starting several hours after she received the vaccine on 12/30/2008. The next day she said that the symptoms were less bothersome but still occurred periodically. On 1/16/2009 she reported the symptoms occurred less frequently, but added that she felt a tingling in her elbow and sometimes in her hand. She experiences the tingling in her right arm mostly after holding heavy items such as her books across her college campus. NOTE: this is her first MMR, she had the Measles disease as a child, and received the Rubella and Mumps vaccines in separate shots.
Four days after vaccines (8/4/09), teen developed pruritus all over body at about 1pm. Five days after vaccines, teen developed red, itchy, warm, swollen rash all over body (including scalp & ears). Rash resolved without medications.
SIDS- we caught it in time to bring his pulse back but he is on complete life support. After the baby had been given the shot the babies crying increased and he used to crawl his knees towards his stomach..which I thought was coming from gas pains but later learnt that this may have been side effects.
Moody, vomiting, loss of appetite, rash, possible febrile seizure.
Large red area upper left thigh: hot to touch. Received Orapred and Duricef
01/21/2021- FIRST DOSE OF MODERNA 02/16/2021- 2ND DOSE OF MODERNA 08/19/2021- SYMPTOM ONSET. SHE WAS EXPOSED TO RELATIVE WHO TESTED POSITIVE. 08/24/2021- PATIENT TESTED POSITIVE FOR COVID WITH RAPID PCR TEST.
20 hours after injection: four hours of dizziness and pin prick pain (head, torso)/
Rash of the face starting on 8/21/22. Small, red bumps; painful to the touch.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, CHILLS, FATIGUE Narrative:
Client presented to the vaccination site on 08/05/2022 for her Moderna COVID vaccine. Today, the client consented to receive Moderna COVID booster dose #1 (0.25 ml) (Lot #: 006M21A exp: 08/19/22). After reviewing the vaccination forms, worker noted that client never receive any primary series which means she is under dose today since the client received administration of the Moderna COVID booster #1 instead of a first dose Moderna COVID vaccine (full dose 0.5 ml). worker notified supervisor. supervisor submitted a medical consult via text message to the doctor, requesting for guidance on how to proceed.  supervisor received recommendation from the doctor with recommendation to call client to come back today (8/5/22) or tomorrow for the Moderna COVID booster dose #2 to complete the recommended first dose Moderna COVID vaccine of 0.5 ml. supervisor called client to inform her of the doctor's recommendation for her to come back for her Moderna COVID booster dose #2 to complete the recommended first dose Moderna COVID vaccine (full dose of 0.5 cc). Client said to supervisor that she cannot come back until after four weeks. supervisor sent a follow-up text message to the doctor informing him that client cannot come back until after four weeks. supervisor received a text message from the doctor that the recommendation should be for client return today or tomorrow, and if the client decline or cannot come back then nothing can be done today. supervisor unable to educate client on the side effects of Moderna COVID vaccine since client left the vaccination site before the under dose of Moderna COVID vaccine given was noted and unable to obtain any information if client has any chronic conditions, current medications, or known allergies.  supervisor educated on confirming with each client the right client, right vaccine, right dose/time frame, and any history of adverse reactions or known allergies in the future.
4:40pm On 5/11/07 parent brought in child - Left thigh swollen, skin tight, warm to the touch, child was limping, child states leg was itchy. No Peds Physician on site  to examine child. Instructed mother to take child to Peds Urgent Care for evaluation. Mom ended up taking.  6/12/07 Received hospital medical rcords which reveal patient seen in ER on 5/11/07 for erythema, swelling, tenderness  & itching of left thigh where received DTaP & IPV vax on 5/10. Tx w/Benadryl & d/c to home.  Returned to ER later same day w/fever 102.3 & increased edema from waist to patella on left.  Labs done (no reports).  Admitted & started on IV antibiotics.  Erythema & pain markedly improved by next day & was d/c to home.  Vax record accompanied hospital records & VAERS database updated w/corrected vax info. FINAL DX: local reaction to immunization (likely DTaP).
Pt recvd dose of recomb on 14DEC90 & on 14DEC90 pt exp nausea & vomiting & subsequently recovered;
Patient presented with NSTEMI. Cardiology was consulted and he underwent a left heart cath. He remained hemodynamically stable and is being discharged back to his assisted living with skilled nursing. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Discharge Provider: MD Primary Care Provider at Discharge: FNP  Admission Date: 8/9/2023 Discharge Date: 8/11/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] UTI (urinary tract infection) [N39.0]   HOSPITAL COURSE:     Patient is a 78 y.o. female who presented to the emergency department with complaints of chills with nausea, and shortness of breath.  Patient has a past medical history including Wegener's granulomatosis, vitamin B12 deficiency, CKD, hypertension, anemia, persistent atrial fibrillation, combined systolic and diastolic heart failure, and obesity. Patient states that she developed feelings of chills, nausea, shortness of breath and generalized body aches .  She states that approximately 10 days ago, she was exposed to COVID-19 while at a concert.  She developed cold-like symptoms approximately 2 days later.   She presented to the emergency department for evaluation.  In the emergency department, patient was tachycardic, tachypneic, and was hypoxic with activity.  She was afebrile, however.  Complete blood count revealed leukocytosis without lactic acidosis.  CMP showed CKD, which is chronic for this patient.  Additionally, BNP was 31000, which is near baseline for this patient.  COVID-19 was positive.  Urinalysis showed moderate leukocytes without nitrites.  Patient has no urinary symptoms.  Procalcitonin was 7.76 chest x-ray showed no acute cardiopulmonary disease.  EKG showed atrial fibrillation, which is chronic for this patient.  Patient was admitted for further evaluation and management of sepsis due to pneumonia 2/2 COVID 19 and UTI.    Patient was managed symptomatically for COVID-19 pneumonia.  No antiviral drugs or steroids were administered.  Patient was on room air and asymptomatic.  She was treated with IV Rocephin for urinary tract infection.  Blood cultures remained negative.  Urine culture was contaminated.  Given improvement with IV Rocephin patient was transitioned to oral Ceftin on discharge to complete a 5 day course.  Patient was evaluated by PT OT and was recommended home with home health PT.  Patient was discharged home in    PS:  Patient's Eliquis was changed to 5 mg 2 times a day as per renal dosing.
Fever 102.1 F, pain in thigh where injected. Treated with acetaminophen and ibuprofen.
This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX QUADRIVALENT, the subject experience swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX QUADRIVALENT. This case is one of the 5 cases reported by the same reporter for the same vaccine.