chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PINK EYE; HIVES; ITCHED ALL OVER (ON HANDS, BACK AND LEGS); TERRIBLE FEELING; SLIGHTLY INCOHERENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced terrible feeling. On 09-APR-2021, the subject experienced slightly incoherent. On 11-APR-2021, the subject experienced itched all over (on hands, back and legs). On 11-APR-2021, the subject experienced hives. On 12-APR-2021, the subject experienced pink eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itched all over (on hands, back and legs), and the outcome of terrible feeling, slightly incoherent, hives and pink eye was not reported. This report was non-serious.
4/1/2021 3AM (12 hours after receiving the 2nd dose): vomiting, high fever and body ache from head to toe After vomiting several times I had chills for about 6 hours with a high fever.  10AM: chills stopped, but still had high fever, headache and body pain 8PM: temperature was back to normal but I still had full body pain and a migrane headache and fatigue  4/2 Fatigue, body pain, migraine headache and no appetite   4/3 Fatigue, migrane headaches and no appetite 6PM: appetite came back. I ate my first full meal since 3/31.   4/4 Migrane stopped.  But still felt fatigued.  Food I ate the night before stayed on my stomach all days and I could not eat  4/5 - 4/10 On an off nausea and anything I try eating stays on my stomach for more than 24 hours  4/9  Ate a full plate of food for dinner  4/10 Nausea in the morning.
Information has been received from a 69 year old male physician patient who on 23-JUN-2010 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664636/0874Y). Concomitant therapy included valacyclovir HCl. The physician reported that he was using ZOSTAVAX (Merck) and on 29-JUN-2010 he got nauseous and had pain and then on 04-JUL-2010 he developed a rash. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The physician considered his nauseous, pain and rash as an other important medical event. Additional information has been requested.
Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
about 24 hours after the 2nd dose I felt like all my joints wanted to explode, they were tender to the touch, warm and slight edema. This excruciating pain lasted 12-14 hours. I could not even stand to get to the bathroom, I had to crawl as the pain was so bad. Once the pain lessened I was able to stand and move on my own.
Bleeding gums; A spontaneous report  was received from a consumer, who was also a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding gums.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient experienced bleeding gums that lasted about twenty-four hours. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The event of bleeding gums was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I need to ask some questions about adverse allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: X Manufacture Unknown), for Covid-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I need to ask some questions about adverse allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
. Stress response    2. Gastroesophageal reflux disease, unspecified whether esophagitis present    3. Local reaction to immunization, initial encounter      Discussed her situation and options.  Reviewed self-care with healthy diet, finding even short periods of time for exercise, minimizing alcohol (which has increased.)  Discussed the possibility of SSRI, although doesn't meet criteria for depressive or anxiety disorder, and will defer.  In the end, she plans to cut back her work in order to allow more self-care.  She will also check in with her GI surgeon.  Okay to continue occasional Tums in the meantime.   Reassuring exam of supraclavicular area.  Likely transient reaction to vaccine.  Follow up if persistent or new symptoms.
pt recvd vax; had grand mal sz per PAR;RN informed;PC to MD,advised Motrin for fever & seek med evaluation if szs cont;seen by ped;par described intermittent fever & lots of shakiness;fever down w/ apap;no more szs occured;
Spontaneous hearing loss in left ear upon awakening. Initially began as "muffled" hearing. Went to urgent care, was told there was fluid in my ear and given prednisone 20 mg. Hearing went from being muffled to a constant "whooshing" in left ear. Went to ENT, prescribed 60 mg prednisone taper. Auditory studies at initial ENT visit and subsequent visit after steroids showed little to no improvement in hearing loss.
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68,  1440 - pt reports I am feeling better but it does come in waves.  chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home.  does not live alone.
A mother reported that her 6 year old son received an injection of Flu-Shield (1997-1998 Formula) in September, 1997. Within 20 minutes, post vax, he developed generalized hives. He recovered.
After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up and my balance was completely off and I almost fell into glass table. I felt very foggy and my head wasn't right. I had to hold on to things and I sat down and I kept saying I just didn't feel right.  I called my daughter and my arm was hurting and I figure that's what happens, I was getting so tired and really bad headaches. My daughter asked somebody and they told me to take extra strength Tylenol (500 mg ) 2 at a time 6 hour intervals. Which i did i got up the next morning and i had to go back to bed i had no energy. I felt horrible. When i did get up in the afternoon all of a sudden i had horrible chills and that day in Florida it was 82 degrees and i put the heat on 84 and i was extremely shaky and cold. I went back to bed and later i did have a fever, not highs, it only went to 100.8 but during the evening it did break because my sheets were almost saturated. Yesterday morning 1/27 Wednesday i felt better, fever had gone down, pain was still there in my arm and swelling. I thought that was natural. In the afternoon i decided to take a shower and i noticed my left arm around the injection site was a red rash about 7inches long and 4-5 inches wide which  i had to seen before i called my primary doctor just to make sure this was normal around injection site and talked to the nurse and she thought it was normal. But if there was no changes to call her back on Friday. Last night not able to sleep i saw an article that said COVID arm rash seen after Moderna vaccine, annoying but harmless it was a large article and it made me feel better but there were only 14 examples but they believe there were more because they were younger people with the health dept. that received this vaccine. It said in 1week it should go away.  I still have it, its still red and sometimes itchy and i am happy to say now that i know it will be a week i feel better. it should be on the list of side effects for all.
injecting vaccine to patient less than 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injecting vaccine to patient less than 18) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injecting vaccine to patient less than 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injecting vaccine to patient less than 18) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact
Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of PREVNAR (manufacturer unspecified) (strength, dose, route, lot# and expiration date unknown) and then "3 days later" received a dose of PNEUMOVAX 23 (strength, dose, route, lot# and expiration date unknown). The company representative stated "this occurred in November". No adverse effects reported. Additional information has been requested.
patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.
62 yr. old male  took no prescriptions or drugs prior, yearly received flu shots, had a high technical job, very active and healthy. 10/2021 Patient had COVID, received the 4 anti-body shots 11/21 till 3/22 experienced sever hair loss, taste and smell. Patient was a employee for Technology company and required to receive the vax.  J&J was not available at the time Patient received the 1ST Moderna vax on 1/20/22; 90 days after anti-body shots as recommended by medical staff.   At the time of injection, he experienced pain in left arm, 4x4 red swollen area, for about 4 days.  Within a week had pain across back of the head, heaviness in chest and cognitive decline issues, lack of concentration. 2/17/22 Patient received 2nd Moderna vax.  In addition to the prior symptom's, patient experienced sever insomnia, sever anxiety and depression, and erectile disfunction. 6 weeks later admitted to the hospital. After a PCP visit, patient was admitted to hospital with suicidal ideation severe anxiety.  NO prior family or personal history of mental health.   4/1-4/18/2022 hospitalized and discharged with no meds or follow-up doctor or therapy appointments. 4/29/22 re-admitted to hospital, via ambulance, presenting like Parkinson, tremors, unable to walk, lack of communication, some delirium.  Noted as a possible drug withdrawal from previous visit.  Took off controlled substances too quickly.  Diagnosed with catatonia, severe depression and anxiety.  5/13/22 transferred to another hospital, with a psych wing, for treatment and began ECT sessions.  Discharged from hospital 6/8/22 with meds and future appointment with a therapist and psychiatrist and follow up OP ECT sessions for another month or so.  Continued therapist and psych Dr appointments to this day.  8/2022 consult with Neurological Institute.  Had MRI and EEG  both unremarkable. Patient continues on 4 medications and under weekly therapist and 2x/month doctor's care. Some improvement, not much.   Patient is currently on LTD from his job as of Sept 27/2022
POST NASAL DRIP; This spontaneous report received from a patient concerned a male 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 not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced post nasal drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from post nasal drip. This report was non-serious.
Redness, swelling of the upper arm three times normal size that spreads to upper arm, pain in the scapula, neck, and armpit.
Swollen lip. Bumps. Swelling. Tingling to the right of mouth. Skin is sagging above eye.
at injection shot warm to the touch, hard/ slightly swollen, redness ( looks like could be "covid arm " )
got COVID on 07Aug; got COVID on 07Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Aug2022, outcome "unknown" and all described as "got COVID on 07Aug".  Clinical course: Patient reported that she has an appointment today at 5:20 pm for the new variant of Pfizer COVID-19 Vaccine Bivalent and was just concerned because she just had COVID about 40 days ago. She was confirming if she was able to get it or not because she got her last Booster Pfizer COVID-19 Vaccine on 02May and then got COVID on 07Aug. So, she wants to know if she can still get the Pfizer COVID-19 Vaccine Bivalent or not and don't want to get transferred to multiple people to get an answer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine administered to 17 year old.  No ADR's reported.  Per CDC website, encounter should be documented in VAERS and 2nd Moderna shot given per usual protocol.
This is a 67y.o. male   Patient's past medical history of central hypertension congestive heart failure nonischemic cardiomyopathy the patient's ejection fraction 35% the patient has been diagnosed with coronavirus multiple days ago with symptoms with worsening shortness of breath myalgias fevers chills the patient chest x-ray and troponins were noted and negative EKG had PVCs no significant changes the patient also had several episodes of ventricular arrhythmias with 9 beat and also seen by Cardiology as well.  The patient was seen by infectious disease as well the patient currently isolation the patient's has no chest pain lipid shortness of breath but appears comfortable otherwise
Patient walked into the pharmacy trying to get vaccinated for Covid. Before anything patient was concerned about her previous Covid positive case (not a severe reaction, was eventually tested negative in April) and also her family history of asthma (Patient herself never had an episode so far). I told the patient it would be okay to get vaccinated, per CDC guideline.  As patient filled out the consent form, I checked the screening questionnaire, which she answered "no" to everything except "don't know" to asthma related questions.  As everything was set I brought patient into the consultation room, explained what vaccine she is receiving, how long it takes for the vaccine to be fully incorporated into her defense system (2-3 weeks), and what kind of side effects she can expect (muscle pain, elevation in body temperature, redness around injection site). I took extra moments to explain risk vs benefits for blood clotting issue.  At this point patient was ready to get vaccinated. I wore gloves, asked patient to roll her sleeves up so I can proceed to wipe the right upper arm area with alcohol and give her an injection. she followed promptly so far to this point.  As soon as patient received the vaccination, her body started to slide down the chair. Patient reported to feel dizzy and also reported that she had some "dreams." Fortunately while everything was happening patient's head did not hit anything and patient was in sitting position the whole time of the event. I asked patient if patient was feeling okay three to four times but I did not get any straight answer from the patient. I asked for help, and pharmacy technicians and store manager offered help.  Patient wanted us to call her husband and 911, which we proceeded. In the mean time I also reached out to my district manager to report what was going on. Store manager offered a room temperature water to keep her fluid balanced, as she was sweating heavily.  Once 911 got to the site, they measured her BP and HR, and it was a bit low. 911 offered a choice to take patient to ER, which PT and her husband first decided to use their own car, and later decided against going to ER. Husband reported that patient is feeling much better, drank a few ounces of fluid and taken a banana.
I woke up with what feels like a golf ball in my arm pit, lymph node swelling I am guessing, I also have some discomfort in my groin though no noticeable swelling. It is day two with it, i did take ibuprofen and used a hot compress without relief.
Pt ordered to receive 4-6 yo Varivax (routine booster) but received Zostavax by staff in error. Pt was doing fine when reached for f/u 3d later (given on Friday PM, reached Monday AM).
Joint pain 3-11-2021 9:00pm - 3-13-2021 10:00pm Fever 3-12-2021 6:00pm - 9:00pm (Ibuprofen resolved the issue) Feeling hot but no fever 3-12-2021 12:00am - 3-13-2021 10:00pm Fatigue 3-12-2021 8:00am - 3-13-2021 10:00pm Injection site pain 3-11-201 7:00pm - 3-17-2021 10:00pm
Petechial rash at abdomen and thorax, ED for r/o TTP. Biopsied for suspected vasculitis. Did recover without apparent sequelae.
sore throat cough earache on my right ear with wax discharge, head and body aches chills sneezing sinus inflammation  loss of taste and smell no fever for three weeks after first dose Doctor prescribed Benzonatate and Azithromycin and Fluticasone nasal spray I am feeling better but I still have a cough and slight congestion in my chest and sinus all my symptoms were not severe
Hives all over body, x 5days, scaling feet and  hands, pain feet with walking, c/w severe sickness; treated Prednisone P8. Benadryl. hives still continue /on/off
Racing Heart, headache, cough, hoarseness, pain in left upper arm and shoulder where given was awake from 3:00 AM until 9:30 when lying down could hear my heart racing.
Mild fever of  99.8, fatigue,  body aches, headache, all fingers are cold, numb and tingling in both hands,  tightness in chest.  Started experiencing symptoms approximately 10 hours after receiving vaccine. Took 2 Tylenol and 2 Ibuprofen for treatment, plan to go to ER if symptoms worsen overnight.
I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion
A. Shoulder Injury Related to Vaccine Administration (7 days) sore at spot next day AM but less in PM.  Today no pain at spot. B. Vasovagal syncope (7 days) Today feel light  headed before meal.  Had good night sleep 10 PM to 7 AM
This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received MENVEO (batch number M16077, expiry date March 2018). On 12th January 2017, the patient received MENVEO 0.5 ml. On 12th January 2017, less than a day after receiving MENVEO, the patient experienced injection site pain and numbness. On an unknown date, the outcome of the injection site pain and numbness were unknown. It was unknown if the reporter considered the injection site pain and numbness to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO in his right deltoid and experienced sharp pain at site. No other information was reported.
Rec'd. 12 mo vaccinations at @CE on 01/12/16. Mom reports pt. with fever beginning 01/14/16. 102 F Max. Also states 'losing balance' easily, clingy, increased sleeping. Seen in office 01/16/16 for s/s. Per dr, likely vaccine reaction. Gait normal in office and temp 8.1. To tx with TYLENOL/MOTRIN and monitor.
Numbness in the face, still present one week from 2nd dose of Pfizer vaccine.
24 hours after injection  swelling. 48 hours after injection  continued swelling, redness, heat, persistent itching. Took Zyrtec and applied ice pack.
Chills and bodyache started first early the next morning. Fever of 101.5 started that evening lasting about 12 hours. Headache the whole time. Took Tylenol
Injection site has become large, red, hard, itchy bump. Roughly the size of a quarter
C/o pain in left deltoid and shoulder after receiving H1N1 injection. Ongoing pain in left arm. Had tingling in fingers/hands but that had resolved.
I am currently 22 weeks pregnant with expected date of delivery July 16th 2021. I was diagnosed with epilepsy in January of 2017. In 2019 i began using lamictal and had zero problems with the anti -seizure medication. One week after my second dose of vaccine i developed a significant rash and experienced extreme difficulty breathing. After seeing a dermatologist and getting a biopsy i was told that i had DRESS syndrome which is very uncommon given i had already been on lamictal for such a long period of time. I have been prescribed a topical steroid as well as 40mg prednisone and am titrating off the lamictal to the keppra (1500mg).
16OCT & 17OCt upper arm hot 7 swollen to itchy; improved each day; 18OCT devel h/a & aching & fever of 104 on 20OCt; had fever next day also & seen by MD;