chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via Pfizer concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: unspecified allergy, and concurrent conditions included: depression, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: Unknown) dose was not reported, 1 total administered to right arm on 15-MAR-2021 for prophylactic vaccination. Age at time of vaccination 49 years old. The patient received additional mon-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and were not reported batch number: 071F21A expiry: Unknown (dose 1), batch number: 048L21A expiry: Unknown(dose 2)) dose was not reported, administered on 29-OCT-2021 (dose 1), and dose was not reported, administered on 02-APR-2022 11:00 (dose 2) both doses to right arm for prophylactic vaccination. Age at time of vaccination 49 years old. Concomitant medications included Niva (ethinylestradiol/norethisterone) (1-5 MG-MCG).  On 19-APR-2022, the patient experienced symptoms (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1). On 24-APR-2022, (on day 5 after symptoms started) she started treatment with Paxolovid (ritonavir). The patient stated that it was very helpful to her, felt better every day after treatment. On 03-MAY-2022 she was feeling totally well (Dose number in series 2). On 04-MAY-2022 (At 05:30) she woke up feeling congested and having drainage in her sinuses and feeling under the weather (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220518282-covid-19 vaccine ad26.cov2.s-suspected 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.
Patient was nervous about getting vaccine, did well after vaccine still seemed nervous would not sit was pacing back and forth but insisted he felt ok then at about 15minuts after shot said he didnt feel well. Patient seemed sweaty , said tongue felt funny,  his blood pressure was taken was 160/96. had patient lie down put ice pack on him checked tongue and throat not swollen, blood pressure didnt come down pulse was 100 so called paramedics. After they arrived they checked his vitals patient started to feel better paramedics decided was his choice to go to hospital patient refused the paramedics said he was stable so patient had someone pick him up instead and was feeling muc better by time he left.
Initial medication error report received on 04 October 2013 from a nurse. A 76 years old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route was intradermal), lot number and site of vaccination was not reported on an unspecified date. The dose was given intradermal to a patient 2 weeks ago and they are just realizing it now. The safety and immunogenicity of FLUZONE ID vaccine have not been established in persons <18 or 65 and over years of age. List of documents held by sender: none.
pt recv vax; rt arm sore & redness just below inject site;sx 2 days p/ vax;
Headache, Very Tired, Fever, Muscle Aches Started at 6pm (9 hrs after injection) and finished at 2am (17 hrs after injection).
Hives started 3  hours after vaccination and have been consistent for 4 days Headache started 1 hour after vaccination lasted for 45 minutes Joint pain started 1 day after injection lasted for 48 hours
On 16OCT91 devel a scratchy throat eyes burning, ache in body joints by Friday 18OCT91 had a raw throat; Saturday t100;
Baby Pfizer administered instead of peds Pfizer. Pt observed for 15 minutes, no adverse effect noted. Pt alert, left in stable condition accompanied by mother
I GOT THE FLU SHOT ON SATURDAY ..WOKE UP WITH SHINGLES SUNDAY..I have never ever had shingles ..had to the doctor and thats what he diagnosed me with.
He started with ringing in the ear; He came down with a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He came down with a severe headache) and TINNITUS (He started with ringing in the ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (He came down with a severe headache). On 15-Mar-2021, the patient experienced TINNITUS (He started with ringing in the ear). At the time of the report, HEADACHE (He came down with a severe headache) and TINNITUS (He started with ringing in the ear) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable
Three hours after the injection lymphodema and low grade pain in the left axilla, the inner left upper arm, the left ribcage and in the muscles of the left scapula. Treated with 50mg of diphenhydramine and prednisone 30mg. The tender lymph nodes resolved over 2 weeks. Pain treated with Vicodin1/2 tablet) and celecoxib 100mg. By 10/10/2020 all meds stopped except celecoxib. The residual pain is now localized to the lower left diaphragm and ribcage below the axilla. Patient is still guarding his deep breathing to avoid moderate pain, deeep to the lower left ribcage. Previously inflamed areas still show hypesthesia and superficial and referred pain occurs with palpitation of deeper tissues. The referred pain radiates to the left scapula. Patient takes Diphenhydramine at bedtime as needed for insomnia due to the residual tenderness of the involved regions
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced breakthrough varicella. Pt was treated with Benadryl, Tylenol and Aveeno.
Parosmia foul smelling odors no one else smells that makes me very nauseous
After receiving vaccination, pt reported heaviness in R arm that went over to the left arm. Provider was sent for at this time, and patient was placed in supine position. VS at 1629 119/70; 96;18;O2sats 97% on room air; pt denies shortness of breath, chest pain. After VS check pt reports R arm heaviness has resolved. At 1641 pt sat up and reported that he was "twitching" and was purposefully moving both right and left shoulders at this time, and was able to stop movement indepedently. Pt then ambulated to waiting room and was dismissed after 15 minutes provider observation.
Post vax of Prevnar #2, pt's arm was sore and had a fever within 24 hours.
Report A0377926A describes leukemia in a 5 year old female who received hepatitis A vaccine inactivated (Havrix). This report was received initially from the mother of the vaccinee and has been confirmed by a physician. The vaccinee was allergic to Keflex. There were no concurrent medications. She had not experienced any adverse events following previous vaccinations. **On 4/11/02, the subject received her first injection (lot # not provided) of Havrix w/out adverse expereince, 76 days later on 6/26/02, the subject began to experience nosebleeds.** On 6/28/02, the subject received her 2nd injection of Havrix (lot VHA709A2, expiry 4/5/02). Later that day, she subject's mother reported that the subject began to experience burning and itching sensations: the mother did not specify the location of these sensations. On 7/17/02, the subject had bruising and a rash while traveling. The mother reported, additionally that the subject had a low-grade fever "w/in one day of (the 2nd) vaccine" and jaundice w/in 3 weeks of (the 2nd) vaccine." **The reporting MD stated that a complete blood count was performed on 7/17/02 and the "results indicated leukemia." The diagnosis was confirmed by bone marrow biopsy performed on 7/18/02 (results not available to mnft'r).** The subject was hospitalized to receive chemotherapy. **The most recent info. was received on 9/17/02. The reporting MD stated** that the leukemia was possibly related to Havrix administration, but "could be coincidental w/shots". The subject's mother thought the leukemia could have been associated w/the 2 injections of vaccine being given too closely together. Although the nosebleeds began 2 days prior to the administration of the 2nd injection of Havrix, the MD indicated the onset of of leukemia to be after the 2nd injection. He considered the leukemia to be life-threatening and disabling. As of 9/17/02, the leukemia was ongoing.
At time of injection there was pain similar to getting Tetanus vaccine, MA alerted me that it might be sore in a similar way for a few days. That evening there was increased redness and swelling at the injection site, followed by a fever throughout the night. The following day, fever resolved, but fatigue continued for 3 days with increasing redness and pain, difficulty using arm, was hard to pull up pants after toileting due to pain and weakness in arm. By day 4 status post vaccine erythema and swelling greatly increased to most of outer upper left arm between elbow and shoulder. Went to urgent care on 6/27/2020, was diagnosed with cellulitis, given rx for Cephalexin 500mg bid x 7 days, resolved within those 7 days.
Starting 05/05/2022, I developed extreme fatigue and slept all day. I took an at home test on 05/07/2022 which was positive. The same day I was swabbed for COVID-19 and it came back on 05/08/2022 positive. For the next 3 weeks, I had extreme fatigue where I was sleeping 16 hours a day, cough and congestion, sore throat, headaches, nausea, diarrhea, body aches and chills. I was seen in the ER at one point with chest tightness and they ruled out pulmonary embolism and pneumonia, and I was prescribed an inhaler. I went to work for 2 days then developed Shingles. I am active duty so the fact that this took me down for a whole month is astonishing. I have not entirely recovered. I had to wear a cardiac monitor for 2 days last week because I was getting lightheaded and dizzy almost every day. I am waiting on the results for that. Also, I am having lingering fatigue.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            The concomitant medications were not reported.  The patient had his last vaccination on Saturday. No treatment information was provided but the reporter was concerned about the drug to be administered for the event.  Action taken with mRNA-1273 in response to the event was not applicable.
I began to experience fatigue, body aches and brain fog the day following the vaccination.  I treated with rest and fluids.  All symptoms resolved within 48 hours.
Case number PHEH2014US020241 is an initial spontaneous report from a nurse received on 08 Oct 2014 with a follow up information received from a nurse on 04 Nov 2014. This report refers to a 16 years old male patient. His medical history was not reported. His vaccination status was not up to date and records were missing. His vaccination history included administration of MENVEO (batch number: not reported) on 02 Oct 2009 which was well tolerated. Concomitant vaccination included GARDASIL (batch number: K004205) at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Sep 2014. The patient was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M14030) intramuscularly at a dose of 0.5 ml in the right deltoid on 29 Sep 2014 without reconstituting with Men A lyophilized component. No adverse event reported following this medication error. Follow up information received from a nurse on 04 Nov 2014: Patient demographics (date of birth age, height and weight), concomitant vaccination, vaccination history, batch number and site of administration of suspect vaccination updated.
Headache, fever, severe chills, nausea, lingering dry cough, no appetite.   Took Tylenol, didn?t help 10/29/21 still not much appetite    Lingering dry cough
pt recvd vax; exp pain & tenderness on lt upper arm per mom; T 39C for 3 days;insomnia & diff moving lt arm;to er for eval;
Pt. recipient Glaxosmithkline Influenza Qaud Inj P Lot# NT2M9 on 10/24/2023 at PCP office. Pt. subsequently received an additional influenza vaccine (info above) at school flu clinic. Pt. recipient parent neglected to notify school nurse child had received flu vaccine on 10/24/2023. If that had been done the school consent form would have been pulled and the incident would not have occurred.
This spontaneous report as received from a registered nurse refers to a male college nursing student patient of unkonwn age. On an unknown date, the patient was vaccinated with two doses of VARIVAX (Merck) (lot#, dose and route not reported) unspecified when, and failed to seroconvert. The antibody tests were drawn recently and results were unknown. The outcome of failed to seroconvert was unknown. Additional information is not expected.
Received MMR, VARICELLA, HEP A, PREVAIR, @ 1:45pm. By 1:50pm had broken out in red rash @ site of injection and on face/neck area. No labored breathing. No other sx's. Rash faded immediately on legs. Still present to face when dc'd. Kept/observed 15" afterwards.
3RD PFIZER COVID VACCINE (LOT 301308A) GIVEN ON 09/16/2021. PATIENT DIED FROM COVID ON 08/18/2022.
Developed severe headache, fever, hacking cough and coughing up sticky phlegm, and accompanying achy tiredness. (TDaP vaccine). Had to stay in bed 2 days.  Hacking cough and spitting up lasted over 9 days.
Right hand pain/numbness/tingling Right hand pain/numbness/tingling; tx chiropractor, XR and anti-inglammatories
Itching; Redness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills) had resolved.            Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-008602.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU - Updated outcome of the events.
more serious reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more serious reaction) in a male patient of an unknown age 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 VACCINATION COMPLICATION (more serious reaction). At the time of the report, VACCINATION COMPLICATION (more serious reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
pt recv vax 25OCT96 & febrile sz occurred 3NOV96 necessitated ER visit;rash occurred 5NOV96;onset of shaking, eyes rolled back in head;drooling non-responsive;felt warm;crying, lethargic;dx febrile sz & lt OM;
C/o tingling & arms & legs X approximately 12 days. No weakness. Intermittent. B/L upper ext from elbows to hands, B/L lower ext from knees to feet.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Received RA PNEUMOVAX, LA Tetanus & LA Influenza immunizations 11/1/10. Noticed right upper arm redness, warmth and soreness & itching 8-10 hrs. later. 11/2/10 saw MD in clinic visit, BENADRYL Rx given. Called clinic triage nurse on 11/4/10 with c/o redness is now down to elbow & up to armpit, area is warm to touch & she "feels achy all the time" - Pt directed to ER. ER ordered Cephalexin 500mg 4 x/day & Ibuprofen 600mg tid.
Recurrent urticaria for 8 wks after vaccination then resolved. Allergy MD agrees poss vaccine rxn.
Fever Narrative: low back and hip pain, fatigue, unable to  walk, gait off
Elevated blood pressure. I have never had blood pressure problems in the past. Doctor advised me to monitor it at home and report if the numbers increase.
Developed lower abdominal supra pubic cramps became severe radiated into legs. Developed sudden numbness soles of feet which ascended to knees w/in minutes - then developed bil LE weakness and could not walk - weakness and numbness came on abruptly - rapidly over 2 - 3 minutes.
5 cm area of erythema and tenderness beginning 1 wk after vaccine at site.
3MAR97 0930 sore neck, w/ h/a;scratchy throat, metallic taste;itchy inj site;malaise;14MAR97 bilat wrists swelling;painful/tingling hard to carry supplies;16MAR97 bilat knees swelling, pain, trembling;
Patient was given the vaccine in a sitter position and remained there for the recovery period due to chance of fainting that he did report has happened in the past. Pharmacist remained with him for the recovery time due to my concern for his likelihood of fainting. Ten minutes following shot patient began arching his entire body and slightly convulsing with head thrashing back. His eyes filed back and this continued for approximately 15 seconds.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: patient received her second dose of pfizer vaccine. After sitting for about 5-10 minutes, she said she was not feeling well. she said she was having a difficulty breathing and her throad feeling "weird", sweating and flushed. she asked to call 911. diapatcher over the phone said paramedics are on the was and do not give her anything. Patient looked stable and left with paramedics
The evening after the day I got the vaccine, I had uncontrollable chills. No fever, cough, rash, just could not get warm. I was covered with four blankets, sweat shirt and pants, and robe.   Since the initial dose, I've had the second dose on 2/26/21, a first booster on 11/30/21 and a second booster on 4/26/22. I believe after one of those doses/boosters I was also extremely tired, and achy, but nothing that ever needed medical intervention.  However, I think I was asked to fill this out because even though I had two doses and two boosters, I contracted Covid 19, as did my husband who also had two doses and two boosters. I began not feeling well at the beginning of June, congested, cough, tired. I tested at home, and continuously tested negative. Due to not feeling well, I missed two days of work. My husband tested positive on June 6. He was treated with molnupiravir and began to feel better. He missed one week of work, felt better, symptoms abated, tested negative, and returned to work on June 13. He then worked for a week and started feeling badly again. His symptoms were back in force. He was tested and was once again was positive for Covid on June 19. On the afternoo of June 22, I was stricken with an incredibly bad headache (unlike my normal tension headaches). I went to be tested and was positive for Covid. Our son who lives with us who was also vaccinated (but no boosters) also tested positive during this time period. We were all treated with molnupiravir (my husband for a second time). My 82 year old mom, who was vaxxed and boosted once, was also positive for Covid last week. She, too, was treated with molnupiravir.  I believe this is why the gentleman who called asked if I wanted to complete a VAERS report. I said sure.  If you need further information, please feel free to contact me.
She got her vaccine, came home and was doing pretty good, laid down and started getting real bad chills like she was freezing.  She got real nauseated, and did that for a couple of hours, and throwing up and having diarrhea as well.  Now her eyes started getting real bad with blurry vision, and scared to go anywhere as she was afraid she might pass out, and started having chills again as she was freezing like she cannot get warm.  She has not taken anything for her symptoms.  She also has been coughing real bad too yesterday and last night.  She basically has flu symptoms.  She called the drug store and told her if it did not get any better to go see her doctor.
Patient presented to the emergency room due to rash. It started 10 minutes after getting flu shot. Has no history of prior allergy to influenza vaccine. Rash started on neck and face and spread after that. She had no throat closing, wheezing or SOB. Treated with IV SOLUMEDROL (125mg) and Famotidine 10 mg. Symptoms resolved, patient discharged and returned to work.
Sitting on steps friend told her 'something' about shot. Reading side effects sheet. Stomach upset. Saw blood on palm. Feeling "yucky."
DTaP and IPV was administered at left upper arm deltoid area on 05/15/02, presented today with a discrete patchy area of erythema, swelling and heat at affected area approx 8 x 14cm diameter. Recommended cool compresses and Benadryl.