chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got a second bivalent booster on May 19, 2023. It was my 6th covid vaccine (first 2, then 2 boosters, then first bivalent, then this second bivalent) all on advice from my primary care physician. About one week later, while having a bowel movement, I noticed a strong, strange smell - not at all like my stool usually smells. I thought something must be wrong with our septic system or even our well. My spouse checked everything - nothing was wrong with the septic or well.  Then, over the next few days, more things smelled exactly the same - my stool, my urine, when I pass gas, dog food, many types of cooked meats and other foods,  even Cherios. It is a strange, sweet, pungent smell. Now, 3 months later, the smell has gotten slightly less powerful, but the same number and types of things smell strange, yet all identical to each other.    I went to urgent care a few days after the smell started. The nurse practitioner I saw said it must be from a cold - except the last cold I had was in late March 2023 - two months eariler. She said to wait a few weeks. On June 28, 2023 I saw a physician in the same clinic as my primary doctor. She said it could be from several things and gave me a referral to an ENT. I saw the ENT on July 17, 2023. I have been  diagnosed with parasomia due to an unknown cause. I think it was the vaccine.
Chills, shivering, aches, weakness, dizziness, sweating and swollen lymph node.
think it gave her/him a heart attack; real weak; right arm still swelled up; feel sick; face turned deep red; wrecked health; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced think it gave her/him a heart attack, real weak, right arm still swelled up, feel sick, face turned deep red, wrecked health on an unspecified date. Time she/he got back to the house she/he almost died. The patient mean it almost killed her/him. Her/his face turned deep red and think it gave her/him a heart attack (clarification unknown). She/he almost died right here at own home (further clarification was unknown) and she/he had a bad reaction, it literally gave 'bumps' in her/his body. The patient called about a month ago and was in 'normalization'. Outcome of the events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Patient had a localized swelling and erythema at injection site.  Also two varicella-form pustules distal to site
Wheal 6" X 4", SOB, chest tightness, Numbness in fingers in arm that received the vaccine, mild lethargy
3 hours - tired, very sore arm 20 hours - chills, severe 26 hours - dizziness, lightheaded, nausea, vomiting 30 hours - all symptoms improving 48 hours - normal, just slightly tired
On 21OCT91 pt recvd DTP/OPV that evening @ 1645 & devel t105 called MD & was prescribed APAP;On 22OCT91 temp dec 103; then resolved by 2nd day;
Patient here on 12/07/2022 at approximately 2:00 PM for Pfizer Bivalent booster dose. Wrong bag was grabbed from Helmer. Pfizer COVID-19, for 12 years and up, 0.3ml was given instead of the Bivalent booster dose. Medication was in a brown paper sack with medication label attached. MD notified. Dr. stated "patients inadvertently given monovalent vaccine for a booster dose needs to wait 2 months before getting a bivalent." Spoke to patient on 12/8/2022. ARIA completed and sent.
4-21-07 Arm reddened round area approximately 1/2" diameter. 4-22-07 Slightly larger reddened area. 4-23-07 Approximately 2 inches in diameter reddened, round, warm to touch. 4-25-07 Employer's nurse states area decrease.
generalized pruritic rasied rash; migrating arthralgias; fever up to 102 daily x 1 month;
I was fine and got the vaccine because of a suspected measles outbreak on the island tha cause travel restrictions and I have atrip planned.  About 8 hours after the vaccine I noted a sharp, intermittent pain in my left jaw area.  At first I thought I had an ear infection or a damaged tooth.  However, the pain is very intermittent and sharp and unpredicable, cosnsistent with trigeminal neuralgia.  I am awaiting an appoint ment with a MD for evaluation.  The episodes of sharp pain are rapidly increasing and now I have this sharp pain in my left jaw/face right below my ear 50-60 times a day.
Patient complains of itching all over and 2 knots that showed up at injection site and on neck
Janssen Covid-19 Vaccine that was stored in the refrigerator was administered 40 minutes after the 6 hour expiration period.  Patient was monitored for 30 minutes after administration in which he only experienced soreness at the injection site.  Johnson and Johnson was contacted for further guidance.  Per manufacturer, they have insufficient data to support stability and was referred to the guidelines Appendix A on the website.  Appendix A recommended to repeat the dose immediately however the patient declined at this time and stated he preferred to wait for the usual booster interval.
After about 3 minutes of the vaccine administration, the patient stated he didn't feel well and then began to faint. His head dropped forward first as he was losing consciousness and he began to turn red in color and start to sweat. We called code white in the pharmacy. When we lifted him upward his head tilted back and his pupils were both completely dilated. He then began to lose the color in face and became very pale including white lips. His body then started to tighten/seize with his arms in a straight forward position. While his upper body was seizing, his lower body was still slumping and sliding down the chair as we attempted to keep him sitting upright. His mouth/jaw appeared to be clenching and the pharmacist thought for a second he almost started foaming at the mouth. Within only about 20 seconds, the patient regained consciousness and stated he just went out of it for a minute. It was confirmed that he did not remember actually having the reaction, so he blacked out for the entirety of the incident. After regaining consciousness and body control, we kept the patient upright and brought him water and ice packs. His skin was still pale and hands were cold and clammy. We monitored the patient for the next 45 minutes. He regained normal skin color and the general feelings of weakness subsided. We took the patient's BP and it was 117/77 with pulse 66. We took it again later and it remained normal. The patient was offered additional medical assistance (911 or EMS) and declined. We continued to monitor and discuss the patient's history in further detail. It was exposed that the patient had history of general anxiety, albeit no history of any seizure or otherwise CNS issues. He had been weaned off anxiety medication and was not currently on any. The patient works night shift and expressed that they had just woken up and he had not eaten any food in the last 12-16 hours. He also confirmed that his current schedule and sleep quality is low. Per his request, the patient got up after 30 minutes and was escorted to and from the bathroom by our AP associate (large enough build to support the patient in height and weight). He finished his water and then confirmed he would go to the grocery side of the store to get food. All symptoms had subsided and vitals were normal after 45 minutes, but the patient did mention having a general "heaviness" in the mouth and felt it was kind of hard to speak or "slow." Given this later symptom, we referred the patient to go to the ER for extended monitoring to rule out any stroke or general CNS issues that could not be seen by the naked eye. The patient's wife was in accompaniment throughout the entirety of the incidence and was fully capable of taking the patient out of the pharmacy with proper follow-up plans.
Pain (3/10) at the injection site on left arm for over 1 month. Pain increased (6/10) and radiated to shoulder, as well as neck area on the left side.
Maternal exposure during pregnancy, first trimester; Baby has been hospitalized for recurrent infections; Baby has autoimmune issues too; premature live birth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-month-old male patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: on 19Nov2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation. The mother of the patient was 30 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Number of previous pregnancies: 1" (unspecified if ongoing); "Lichen Planus in Vagina", start date: 07Dec2021 (ongoing), notes: Pertinent Details: Extreme pain, autoimmune disease, took many many antibiotics. Date of last menstrual period of the mother: 21Oct2021. The mother was 5 weeks pregnant at the time of exposure to BNT162b2. The mother was 5 weeks pregnant at the event onset. The mother is expected to deliver one baby(s) on 28Jul2022. The mother's concomitant medications were not reported. The mother's vaccination history included: moderna covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot: KS139, Anatomical site: left arm), administration date: 20Sep2021, for COVID-19 immunisation; moderna covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot: KS139, Anatomical site: left arm), administration date: 27Oct2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization), outcome "unknown", described as "Maternal exposure during pregnancy, first trimester"; INFECTION (hospitalization), outcome "unknown", described as "Baby has been hospitalized for recurrent infections"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Baby has autoimmune issues too"; PREMATURE BABY (non-serious), outcome "unknown", described as "premature live birth". The baby was delivered premature, delivery date 15Jul2022. Clinical course: Baby was stressed during delivery needed antibiotics.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014645 same reporter/drug, different patient/AE (Mother case);
3 x 5 reddened area, slightly raised. Took OTC Claritin, applied OTC Hydrocortisone. Applied ice to affected area.
Flu HD admin 11-17-17 I (L) deltoid pt states "itching and soreness occurred on 11-22-17". Seen today site with raised nodules and redness. Denies any soreness and itching at present checked with pharmacist given BENADRYL 25 PO to take when gets home and apply warm moist heat. Pt to return on 11-29-17.
Breakthrough case admission after 2 vACCINES Moderna 1/14/21 Lot# 032H20A;  Moderna 2/11/21 Lot# 032H20A
Fever of 100 day 2-5 folowing vaccine, gave motrin; very restless sleep from a normally easy resting child Day 3-6; complaints of headache and dizziness day 4; hives all over torso, chest and butt day 7-8; visited Dr. day 8 and was prescribed steroid; has not returned to prevaccine energy level as of day 8
Physician reported that a patient developed generalized rashes after receiving the first dose of VARIVAX.   The physician stated that the rashes were resolved and the patient doesn't have the rashes anymore.   No additional AEs were reported. No fur; This spontaneous report was received from a physician and refers to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, strength, dose of administration, anatomical location was not provided) as vaccination.  On an unknown date, after receiving the vaccine, the patient experienced generalized rashes which on unspecified date, were resolved. At the reporting time, the patient did not developed the rashes anymore.  Causality assessment between the rash and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported.
drug ineffective; I just tested positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown", described as "drug ineffective"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I just tested positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: It was reported that, Customer Verbatim: I had both doses (Mar and Apr2021) and the booster in October. But, I just tested positive. What the?   The lot number for bnt162b2 was not provided and will be requested during follow up.
After 36 hours after administration, patient developed 1 1/2 inch diameter red, swollen, warm to the touch area that prompted a physician visit. Patient was given antibiotic as precaution.
pt recvd vax & later contracted GBS; pt also exp cold x 3-4 wks; 30DEC94 called MD exp excruciating back pain; 4JAN95 pt examined by MD face & eye were drooping on lt side; pt adm to ICU;
Patient received above vaccination at routine wellness exam on 9/14/2023. Around 8 days later he started with some redness and a lump neat the site of the vaccination. He was seen in the office on 9/29/2023 for this issue. It was determined at that time that he did have an abscess. He was started on Keflex (250mg/5ml taking 10ml twice daily for 20 days) at this visit. There was a culture done of the area at the visit as well that was sent to the lab. The culture came back sensitive to Oxacillin. Per Dr., he should continue the Keflex and the abscess should be resolving. She did follow up with patient on 10/02/23 and was unable to reach them.
Sleepiness an hour after shot, lasted a few days.   Sore arm about 9 hours after shot,  lasted just that day after taking Advil Joint and muscle pain throughout whole body starting 9 hours after shot and lasting 6 days.  Taking Advil helped relieve the pain. 3 days  after shot, pretty bad stomach pain with nausea.  This came and went for 2.5 weeks til I finally went to the doctor.
Abnormal vaginal bleeding and severe cramping, began on 3/1/2021, outside of overall regular and predictable cycle. Approximately 1 tennis ball size amount of blood clots and light bleeding after. 4x severe cramps, like labor contractions, just prior to passing blood clots.  Suspected possible miscarriage in not yet detected pregnancy.  Family member and on call medical assistant for patient's PCP encouraged ER visit on 3/2/2021.  First vaccine administration was done on 1/11/2021 Moderna Lot number 011L20A.
This is an 18-year-old male here complaining of pain in the left chest wall just inferior to the axilla.  Patient states it started 3 days ago 1 day after the Covid vaccine of Pfizer was given in the ipsilateral arm. Patient states he feels swollen with some numbness and tingling in that area and also in the left forearm.  Mild tenderness to the left chest wall that is improving. Instructed patient to use anti-inflammatories as needed.
The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up; The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), LORATADINE (CLARITIN [LORATADINE]), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and MAGNESIUM for an unknown indication.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up). At the time of the report, DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) outcome was unknown.            Patient received 2 Covid Vaccines and 2 boosters. Patient had the first vaccine on 17-Mar-2021, the second vaccine on 14-Apr-2021, the first booster on 04-Nov-2021 and the second booster on -Oct-2022.   The second Covid booster completely knocked her out, then it was clarified as she could not feel her hands and could not stand up, she stated it did its job, kept her out of the hospital but it was rough for 24 hours.   It was reported that all the vaccines were Moderna.  Treatment Medication use information was not provided by reporter.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: From 25JUN2022 to 29JUN2022, patient received COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events and the suspect drug cannot be excluded.
Patient developed chest pain, palpitations, SOB and "feeling like throat closing" approximately 10 minutes after receiving vaccine. Hx of anaphylaxis from penicillin and cipro. Pt was given oxygen via non rebreather mask,  Epipen and transported to ED via paramedics.
Developed COVID, tested positive; Developed COVID, tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP6955), on 17Apr2021 as dose 2, single (Lot number: EP6955) and on 19Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 62 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "Developed COVID, tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Facility type vaccine: Public Health Clinic/Administration facility. Patient did not receive any other vaccines within 4 weeks or 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient tested positive for covid post vaccination. Covid test type post vaccination=Nasal swab, Covid test name post vaccination= BinaxNOW.
Presented to ED for evaluation of generalized lower extremity weakness, falls. The patient states that he carries a diagnosis of MS and typically is fully functioning without assistance of a cane or walker. The patient states that yesterday morning around 0900 he received the second dose of his Moderna COVID-19 vaccine and was otherwise feeling fine but by last night (12 hours after the vaccine) the patient states he tried to get out of bed and was transferring when he felt his bilateral legs give out, causing him to slide to the ground. His wife then came to help and states that the patient was completely weak in the legs, and was unable to even lift his legs up to get back into bed. They then tried to walk him again a short time later and he again stumbled with weakness in his legs. Since that time, the patient states he has been minimally ambulatory and has been using a cane, but still needs large assistance to get around his home. The patient states he has baseline foot drop but feels this is worse in his legs today. He went to clinic this morning for his symptoms where he was noted to have an elevated temperature and was diffusely weak in his lower extremities. Given this, the patient was referred to the ED for further evaluation. The patient denies any weakness in his upper extremities or facial asymmetry. He denies sensation change in his extremities nor any recent illness such as cough, shortness of breath, chest pain, sore throat, nausea, vomiting, urinary symptoms, or leg pain. He has no history of stroke. He denies any injuries or head injury, syncope from his falls. He was admitted to the hospital where he will receive further symptomatic treatment as necessary. No treatment provided in emergency department for weakness.