chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt nothing at all adversely at the time of administration. I returned on 04/21/2021 for the second dose, but elected to wait the two weeks longer, as offered. On the 34th day after the first dose I broke out in hives in several areas, including upper thighs, upper and lower arms, hands and neck. I have not had an outbreak of hives for nine years and have not changed anything in my personal care routine or food selections. Some of the hives are very small, some are larger and inflamed. The lesions are very pruritic.  I have no way of knowing if the hives are related to the injection, but since there is nothing else new that I know of to account for them I felt it best to report it, which was suggested by my local pharmacy as well. I am now very concerned about getting the second dose this coming week. Since I have a long-standing autoimmune condition, could this be a delayed reaction?
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years 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 included: (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "known allergies Gluten" (unspecified if ongoing); "known allergies Latex" (unspecified if ongoing); "known allergies Raw tomato" (unspecified if ongoing); "known allergies Nickel" (unspecified if ongoing); "allergy Beeswax" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Vaccine received and Other medication in 2weeks was received. Patient had Paxlovid for Indication of COVID-19 treatment start date on 19May2022 and stop date on 23May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bivalent (booster) Pfizer vaccine given by error as a first dose. The patient never received COVID vaccine before. No adverse effect noted. No symtoms. Patient is doing well per parent. Error communicated with the parent.
Client fainted within 5-10 minutes of receiving shot. Not witnessed by health department staff.  According to witness, Client waiting in line to get back to school pictures taken when she took a couple of steps backwards and then fell back onto the carpeted floor. Jerking movements observed. Client hit back of head witness said and also said she woke right up.   Client's legs propped up. Once staff from Health department arrived client assisted up and moved to classroom where it was cooler. Given water and juice to drink. Reassured client, mom, and witness that fainting was fairly normal for this age group after vaccine as well as the jerking movements.  Client stated she only had a piece of toast for breakfast and no fluids. Client started to turn pale again. Was laid down and legs elevated. Did not pass out again. After 5-7 minutes of lying down. Sat up and encouraged to finish drinking juice and water. Observed client for another 10 minutes. Discussed with parent to watch for signs of concussion. Client did not complain of any head pain or HA when questioned. Denied nausea.   Follow Up phone call 8/12/2022 to mom. Mom stated client did fine the rest of that day and this morning. Denies headache or other signs of concussion.
After administration of the vaccine, the patient had seizure like activity, arms clenched, body stiffened and unresponsive for several seconds.  After the incident the patient reported that this type of reaction had happened before in the past.
right arm aching; vertigo; for 3-4 days she had body aches/occasional body aches; headaches on and off; for 3-4 days she had chills; nauseated; dizziness or vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness or vertigo), PAIN IN EXTREMITY (right arm aching), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches) and HEADACHE (headaches on and off) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness or vertigo), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches), HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated). On 25-Aug-2021,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PAIN IN EXTREMITY (right arm aching). In August 2021, DIZZINESS (dizziness or vertigo) had not resolved, HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm aching) and VERTIGO (vertigo) had not resolved and MYALGIA (for 3-4 days she had body aches/occasional body aches) was resolving.            She's a vaccine compromised person, has had vaccine injury. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Patient received second dose on 13-AUG-2021 and developed nausea, headache on and off, dizzy during first week and 3 to 4 days. By the sixth day she had only dizziness or vertigo and occasional body aches.
After the vaccine 26 hours later - sore arm but 2pm I got fever 101 and did not go away for weeks. Called PCP for 3 weeks and did not get to see the doctor. Bottom of feet was sweating and sweating all over and vomiting and diarrhea and I was supposed to take second dose. My fever went down and got the shot and fever ended after the 2nd shot. 2 days after my 2nd dose, I had menstrual flow and it never stopped and very heavy from April to October 14, 2021. Sent endocrinologist and got conflicting information. Months later, there was improvement and need to get sugars down. No more prediabetic and Hashimoto's in 11 Oct 2021. Menstrual bleeding stopped 14 Oct 2021 for 25 days. Underlying condition 2014 - arrhythmia and defibrillator, gastric bypass weight surgery in September 2008  and endoscopy and saw blood and severe infection in stomach and in Jun had endoscopy, OB/GYN and hematologist and other specialized, flared up and swelled up and internally. Blood cells were tiny, no B12 in liver. Still having endoscopy in December 2021. Haven't eaten any solid foods.
Johnson & Johnson Janssen EUA Community Vax Clinic -- patient c/o feeling hot, progressed to diaphoretic, briefly obtunded level of consciousness; eased to floor, legs elevated, recovered quickly, escorted to post vax for further observation
Information has been received from a physician concerning a approximately 15 month old patient who on 07-MAY-2009 was vaccinated with the first dose of MMR II (lot # 663765/0215Y).  A couple days later the mother called and stated that the child had a rash.  The patient sought unspecified medical attention.  Additional information has been requested.
Fever,(100.2), Severe Body Aches, Muscles, Bones, Joints, Head Ache.  I continued with over-the-counter meds including aspirin.  Severe  symtoms lasted for about 30 hours
Information has been received from a physician concerning a 24 month old male who on 7/3/03, was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot # 644571/1160M). There was on illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR administered in the right thigh, and a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 643164/0285M) administered in the right thigh. Subsequently, on 8/27/04, the patient developed a breakthrough case of varicella. The patient had 10 lesions, with 1 being vesicular and the 9 other were papular. No additional information was given. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic test or laboratory data. No additional information is expected.
Approximately 28 hours after vaccine, I began to feel tingling in my right eye Approximately 12 hours after that, my face started drooping and was numb so I went to ER.  Today is Sunday, and the numbness and drooping was called Bells Palsy at the hospital.
The day the vaccine was given, in the area where it was given was sore. Red whelps that look like a handprint near armpit area that's very sore and heated.
Fully vaccinated with Covid19 Moderna EUA 04/20/2021-06/01/2021
Patient was injected with the expired dose of ActHIB with no reported adverse event; Initial information was received on 18-Jun-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves one-year-old male patient who received expired of 0.5 ml fourth dose HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ320AAB and expiry date: 13-Jun-2021] via an intramuscular route in right thigh on 15-Jun-2021 for prophylactic vaccination (expired product administered).  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) for Prophylactic vaccination.  Medical history, medical treatment, vaccination, and family history were not provided.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
mom states pt became fussy @ about 7AM on 20SEP96;noted high pitched crying & pt became focal w/staring for about 20min;mom states amb was called, came to home but pt was fine & OK by time of amb arrival;@ clinic 830AM asymptomatic;
Pinched Nerve; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient had his first dose on 15Mar2021 and second dose on 06Apr2021. He was asking if he can start taking the Prednisone since this was prescribed to him due to Pinched Nerve. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Feeling of sandpaper in eyes; Mild congestion; chills; Muscle aches; temp of 99.6; This spontaneous case was reported by a nurse and describes the occurrence of OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 007MZ0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6). At the time of the report, OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.   This case was linked to MOD-2021-368999 (Patient Link).
MILD COVID-LIKE SYMPTOMS/  FELT ALMOST LIKE A  LITTLE TOUCH OF COVID AGAIN; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 135 pounds, and height was 60.5 inches. The patient's past medical history included: covid-19, and concurrent conditions included: panic attacks, and hormone replacement therapy. The patient experienced drug allergy when treated with prednisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attack. On an unspecified date, the patient experienced mild covid-like symptoms/ felt almost like a little touch of covid again, sore arm, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild covid-like symptoms/ felt almost like a little touch of covid again, sore arm, and nausea. This report was non-serious.
cough; sore throat; headache; stuffy nose; joint aches; stomach felt queasy; fever of 100.6 had to go to bed; tired; Slept until 11am; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included influenza (had few times before vaccination). Previously administered products included Flu vaccine (received on an unknown date last year).   On 16th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sleep excessive and tiredness. On 16th October 2020, the patient experienced cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy and fever. On an unknown date, the outcome of the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness were unknown.   It was unknown if the reporter considered the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: Patient had the flu a few times in life and until last year, never had a flu vaccine.  The patient had 1st flu vaccine last year and did not even got the sniffles. The patient received the Influenza vaccine Quadrivalent and 2 hours later, the patient had cough, sore throat, headache, stuffy nose, joint aches, stomach felt queasy, a fever of 100.6 had to go to bed. The patient was scared that I caught the rona (unspecified). Slept until 11 and was tired and that afternoon patient was mowing the lawn and trimming the hedges. Patient stated that on Sunday had clearing the trail to deer stand getting ready for this weekend's opener, who knows, next Saturday I might fall out of it and break my neck.
Awoke at 12:30AM feeling weird - like things were crawling on her.  Temperature 104 degrees, up again to 101 during the day/evening.  Resolved within 24 hours.
Patient started to softly cry that her leg hurt about 1 minute after shot was given...her eyes were gazed over, EXTREMELY PALE, face "fell" and she went limp.  She was out of it for about 15 mins.  She was rushed from the clinic to the ER and they called it a vaso vagal reaction, however, I am certain it was a side effect from the shot!
Headache, vomiting x1 upon waking, resolved by mid morning. Symptoms gone by 10:30 am.
Severe, 2 week long right frontal headache, 2 ED visits, treatment for migraine, IV Meds, CTA, IV fluids, March 2022,    F/U MRI May 2022 showed right frontal intracranial hemorrhage, admitted to tertiary hospital, Cerebral angiogram completed, CT chest/abdoment/pelvis, normal , Angiogram no deformities.  D/C on BP medications, Atorvastatin, Baby aspirin.   MRI follow up x2 for resolution of bleed, diagnosis ischemic stroke that bleed.   Labs continuing to show high platelet count, Hematology visit with diagnosis of PolyCythemia Vera,  JAK2 mutation present.    Bone Marrow biopsy confirmation of Polycythemia Vera January 2023
I developed trigger thumb or reactive arthritis on both thumbs of my hand after receiving the vaccine. It has been 9 months and the symptoms are still there.
Pfizer-BioNTech COVID-19 EUA  metallic taste in back of mouth
Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on  all night about completing a task I couldn?t understand, was irrational,  and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.
Redness, swelling and pain at injection site (R) deltoid. Advised OTC Motrin/ice pack.
Patient c/o feeling bad. I ask for him to explain "feeling bad" he could not. I explained it is possible to feel tired. He stated that he did not feel tired. I asked and he denied the following: Pain at site, H/A, shoulder pain, feverish, redness at site of injection, confused, S.O.B., tongue swelling, rash on body. I also asked if was taking any medication or consumption of alcohol, which he denied. He asked if there was anything that he could do. I stated rest and Tylenol for pain. Symptoms should resolve in a day or so, if not seek medical treatment either with his PCP or ED if conditions worsen.
Patient reports the following after the 2nd dose of Shingrix : muscle aches (generalized), redness/splotches on right arm (not limited to injection site however), headache, and shivering-- >these symptoms started on 10/3/19. Redness on arm went away after "several days" but a red sore appeared "halfway between knee and thigh of the right leg"; around 10/6/19 red spots appeared as well on left leg and that evening when she took a bath both legs really burned and itched badly. Since 10/6/19 the rash started spreading from knees up to "personal area" on both sides...rash looks red and very "thick/scaly". Primary complaint is that it "hurts/burns/itches", arm seems to be worse than legs at this point and this is her primary complaint.  Patient saw primary provider 10/15/19, thoughts were that this was a shingles rash (pt has had shingles twice in the past) or allergic reaction to something in the vaccine. She does have a latex allergy but the package insert states no latex is used in the rubber stopper. With the first dose patient remembers having a very sore arm starting a couple weeks after the shot and lasting for "several weeks"; no rash, just soreness with dose 1. Provider recommended topical Sarna as needed and Benadryl at bedtime to help with itching. Patient reports this has been helping a little but rash is still prevalent.
PATIENT RECEIVED 1ST DOSE OF MODERNA COVID VACCINE ON 4/8/2021. HE PRESENTED TO DIALYSIS ON FRIDAY 4/9/2021 MORNING. HE HAD A FEVER OF 101.4, LABORED BREATHING, AND HYPOTENSION. HIS DIALYSIS SESSION WAS CUT SHORT AND HE WAS SENT TO PCP OFFICE FOR EVALUATION. HE IS CURRENTLY IN CLINIC, RECEIVING A CBC AND CHEST XRAY FOR FURTHER EVALUATION.
prescribed paxlovid; prescribed paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine manufacturer unknown (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), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual flow the day after vaccination and it went on for 8 days. I had body aches on my left side only. Was not able to stay awake an entire hour. Slept 3/4 of the day away for the first 4 days. It was hard to focus or read any information.
Patient began to experience some dizziness and lightheadedness and felt faint. the EMTs on site took his vital signs and discovered he had low blood pressure. 911 was called and transport arrived. He mentioned to the medics that he has a history of severe anxiety. After about 20 minutes they decided there was no need to transport him to the hospital since his vital signs were returning to normal.
Pt reports that she started experiencing severe pain in her left arm about 3 hrs after vaccination. She states this pain remained in severe intensity for about 4 days following, then slowly resolved. She also complained of redness at injection site, mild warmth at site achiness in her deltoid region and top of forearm into top of hand with occasional burning sensations. She states upper arm area was "swollen and bumpy". She did remark she felt that vaccine was given "to the side" of deltoid.
Sore arm after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, 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 experienced VACCINATION SITE PAIN (Sore arm after the second dose). At the time of the report, VACCINATION SITE PAIN (Sore arm after the second dose) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient had a sore arm after the second dose.   This case was linked to MOD-2021-363822, MOD-2021-363885 (Patient Link).