chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approx 11:30 mom called and they were in the car and mom states that she is very itchy with hives everywhere. Coughing started right after shots and she vomited and her eyes are puffy. She was told to come right back to clinic. She got here no breathing problems also no wheezing, but itching a lot and hives everywhere from head to toe-big patches. Her face and eyes were very swollen and puffy, no cough here and no vomiting here. Diphenhydramine 20mg IM given. Symptoms drastically improved within 5 min of injection. Observed for 20 min and sent home.
Lg local reaction, starting 4/26. When seen by me, 4/28 had erythema, induration measuring 12x9cm approximately 3/4 circumference on upper arm suspect cellulitis, treated with Abx.
Swelling, pain at injection site, hardening about an inch in diameter, feeling hot to touch, redness.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
The donor presents with C/O pain at the site as well as elbow and hand. She rates this pain as a 6 on the pain scale.
Patient felt faint after receiving her second dose of the Moderna COVID vaccine. Patient was responsive but lying down on chair in the waiting room. EMS was called. Patient then disclosed that she had felt faint after her first vaccine as well. EMS took her vitals, which were all normal, and she stated she was feeling better but was not ready to leave yet. EMS left and patient was observed in the waiting room for 15 more minutes and then left feeling better.
Transverse Myelitis. Hospital dates 1/7/01-02/09/01. The 60 day follow-up the doctor states that, "I don't think that this disease is related to the vaccines given."  Follow up:  Patient is a 10-month old boy who presented to the ER with fever, extreme lethargy, and some vomiting.  He had been in good health in the morning, and then around noon that day became whiny and seemed not to feel well.  He vomited once later in the afternoon.  Subsequently he was listless and floppy.  He started to develop low-grade fevers around 100.5.  He started to refuse to eat.  Because of his listlessness and fever, plus the fact that he had not had a wet diaper for many hours, he was taken to the ER.
21mm x 31mm erythema/induration without tenderness at site, 11 days after MMR vaccine bruising proceeded erythema
pt recv vax & devel an 8cm area of redness, itching & swelling around inj site;the swelling progressed to the elbow & became painful;pt was treated w/DPH & recovered;
The safety needle was not tightly attached to the syringe and patient did not get the full dose. patient did not have any symptoms or side effect and he is aware of the incident
On day 8 after injection my arm was red and blotchy all around the site.  It is not sore.  It looks like ?Covid arm? that I have seen a picture of.
extremely swollen arm at site of injection  severe headache and low energy level started on Saturday after injection  and by that afternoon actual skin hurt all over by Sunda afternoon running low grade temp and headache alone with low energy level
BURNING AROUND THE EYES; IRRITATION IN BOTH EYES; BAD RASH AROUND BOTH EYES; ALLERGIC REACTION INCLUDING SNEEZING; ALLERGIC REACTION WITH COLD LIKE SYMPTOMS; ALLERGIC REACTION WITH EYE TEARING; REDNESS AROUND THE NECK; BODY PAINS; CHILLS; FEVER; NAUSEA; LEFT SHOULDER PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body pains. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced left shoulder pain at the site of injection. On 12-MAR-2021, the subject experienced allergic reaction including sneezing. On 12-MAR-2021, the subject experienced allergic reaction with cold like symptoms. On 12-MAR-2021, the subject experienced allergic reaction with eye tearing. On 12-MAR-2021, the subject experienced redness around the neck. On 12-MAR-2021, the subject experienced bad rash around both eyes. On 13-MAR-2021, the subject experienced burning around the eyes. On 13-MAR-2021, the subject experienced irritation in both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction including sneezing, and allergic reaction with cold like symptoms on 14-MAR-2021, and body pains, chills, fever, nausea, and left shoulder pain at the site of injection on 12-MAR-2021, was recovering from redness around the neck, and had not recovered from burning around the eyes, allergic reaction with eye tearing, bad rash around both eyes, and irritation in both eyes. This report was non-serious.
Sharp pain under/behind left side of jaw, Received Gabapentin 100 mg 2x @ night 1x in the morning on December 18, 2022.
66-year-old gentleman who received his first COVID injection on Friday.  His family member feels that since this time he has had some drooping of the left eyelid and then today while they were making love he had a several minute episode of vertigo.  He states that may be lasted 1 to 2 minutes.  His wife states he was "unresponsive" when I asked what she meant by that she states his eyes were closed and his eyes were open and he stared.  She states this lasted for 4 to 5 seconds.  He denies headache, double vision, blurred vision, tinnitus, focal neurologic complaints.  He denies neck pain, back pain, chest pain abdominal pain, syncope, near syncope, abdominal pain, extremity pain. He has no history of CVA/TIA.  He denies any history of trauma.
No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T039467, expiration date: 20-MAY-2023 (strength, and route of administration were not provided) for prophylaxis. The vaccine experienced temperature excursion of 33.4 degrees Fahrenheit for 2595 hours (product storage error). There was no previous temperature excursions. No other adverse events reported (no adverse event).  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA007997: US-009507513-2203USA008063: US-009507513-2203USA008097: US-009507513-2203USA007915:
Severe Vertigo 3 days after injection with headache.  Unable to stand or walk on my own.  ER visit to local hospital.  Treated with anti vertigo drugs via pill form.  diagnosis unclear Vertigo.  visit to Dr. next day.  Diagnosis Vestibular Neuritis.  Treated with Pregnasone and Meclizine.  Next day felt better, but not normal.  Severe vertigo was gone, but headache and dizzyness/lightheadedness persisted.  Now, at 1 month post i am still not normal.  Headaches come and go.  Dizzyness comes and goes.  Mind is a bit foggy at times.
administered liquid only portion of Menveo, not mixed with the lyophilized A component; administered liquid only portion of Menveo, not mixed with the lyophilized A component; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the  patient was administered liquid only portion of Menveo, which was not mixed with the lyophilized A component prior to administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
bumpy blotches; red / at the vaccine site; vaccine site / itching started today; left arm started hurting immediately after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 12:00 (Lot number: EN6206) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to penicillin" (unspecified if ongoing); "allergic to Tetanus" (unspecified if ongoing), notes: rapid heart beat, states she was in her 30s. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Mar2021, outcome "recovering", described as "left arm started hurting immediately after the shot"; RASH MACULO-PAPULAR (non-serious) with onset 23Mar2021, outcome "not recovered", described as "bumpy blotches"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "red / at the vaccine site"; VACCINATION SITE PRURITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "vaccine site / itching started today".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that her arm started hurting immediately after the shot and has gone from severe to mild, and states it was the same day as the shot. The bumpy blotches that are red are at the vaccine site and the itching started today (day of report).  No follow-up attempts are possible. No further information is expected.
Within 2 days, hives broken out on body that have continued to get worse.  This is still persistent till present time,, 2 months, 1 week later.  I have seen primary doctor, my allergist regarding this.  Obid has run multiple labs showing  all  mostly normal except for allergic reaction and large increase in cholesterol form last July.  Cholesterol has run almost same (normal)my entire life and now at 249.  I am now in 4  (24 hour tabs Allegra) QID, Pepcid  40 BID, Vanicream, Triamcinolone 0.5% cream, and Tylenol for pain.  The hives continue to run rampant most days, calm a few days.  They burn like an iron burn on your skin, itch madly, and swell.  At times, there is so much fluid retention from them that I am totally miserable and depressed.  I was also put on Doxepin (for itching side use but unable to tolerate due to blurred vision.  Treatment is not in control  of hives, but does help somewhat.  I always have quite a lot and much extreme discomfort.  Unknown if this will be permanent or how long it will last.
On day seven, around 7:00 PM, my arm became very itchy, red, and bumpy.  It had also been a bit swollen and hard all week.  I put hydrocortisone cream on it and it helped a lot.  As of now, the morning after, it is still red and itchy.
T/C from Mom has chicken pox, like rash on face, chest, back, hands and legs, 50 vesicles c/o pruritus, no fever, no cough, c/o sore eyes.
Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m. on 13 NOV 2009. Reference no: NA09-008308.
Swelling from mid-upper thigh down to knee, red painful hot to touch. Pt is unable to walk on foot. 4/1/2014 1:39 PM > spoke with mom, his leg is better, no fever, walking, BENADRYL is helping. Yesterday he was fine. Then gave him BENADRYL and TYLENOL, now better. Continue BENADRYL and TYLENOL. To be seen if it does not improve, please cx today appt and fill out VAERS.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient  (patient ID # 1709295) of unspecified age and gender. On 12-MAY-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015) 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (celsius) (above mentioned temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Threw out the day my daughters leg got a big red circle, under that was a large bump under the injection site the got bigger, it is warm to touch and she has a low grade fever.
Adverse events : PT c/o "feeling weird in [her] throat." No shortness of breath noted.  Treatment: PT directed to lay down, vital signs were obtained, water was provided and consumed, aid was called at 1149 and arrived at 1150. (Vital signs at 1150: HR 90, RR 16, SPO2 100%. At 1153: BP 130/62, HR 82, SPO2 99%).  Outcome: PT reported that she felt better, denied other c/o. EMS medically cleared PT. PT departed in private vehicle with mother.  HCP responding: RN, RN, EMT, EMT.
30 minutes after shot, patient became nauseated which lasted for two days, and received a sore throat on the third day. Minor cough accompanied by cold like symptoms.
Patient given Pfizer vaccine around 6:28 pm , within one minute of vaccination patient fainted and lost consciousness while sitting in vaccination chair. Pharmacist arrived back to patient's side within one minute and patient regained consciousness almost immediately. 911 was called and EMS arrived, BP assessed, taken to ambulance for assessment where BP recorded 80/33 and HR 40 bpm. Patient taken to  Hospital
The day after the Varicella Zoster vaccine my daughter had a 2"by2" hot,hard,red,hurting, itching spot. By 10p.m. 12/6 it was 6"by3". Went to urgent care, they said to give her benadryl and prescibed hydrocortisone cream usp 2.5%. On 12/7 it was 7"by4" and still red,hot,hard,burning and itchy. Went back to urgent care and was prescibed Atarax 25mg.Was told she had an allergic reaction to the shot because she has had it before with no side affects. I asked if it needed to be reported and the docter told me I could. She is getting better now and the spot is a 2by2 faded, itchy,dry patch now. She has had the shot 8yrs before with no problem. Was told she needed this 2nd one. Did call kaiser advice nurse twice as well.
pt turned around to sit down and got dizzy. She fell to the floor. We called 911 and management, stayed with the patient (she was still conscience) until paramedics arrived. Pt stated she was very nervous about getting this immunization, I gave her a cold wet towel to put on her forehead. The paramedics released her to follow up with her primary care physician (which she did not list on our immunization form). I tried to call her home about 3 hours later to follow up, there was no answer
Flu-like Muscle Aches; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CR8735) via an unspecified route of administration in the left arm on 21Apr2021 at 14:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had no known allergies to medications, food, or other products. The patient had received other medications (not specified) within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 18:00, the patient experienced flu-like muscle aches. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event flu-like muscle aches was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Fever 101; chills; aching muscles and joints; local reaction, redness, knots, sore to touch. Warm, moist compresses.
Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  left message that she is to return to clinic to receive additional 0.25 ml of same per vaccine provider recommendation.  She has been unavailable but her partner is aware that she should return or return call
Stating over-nite about 10pm on 4/3 and so far into 4/4 (8:00am) Chills Weakness Mild Headache
Mom called to report that patient developed hives, welts all over torso.  Pt was advised to call family doctor.
Patient felt dizzy and had epileptic episode witnessed by caregiver History of epilepsy and allergies to Ritalin and phenergan Patient seen by medical team Patient given versed and nonrebreather for oxygen, heart rate elevated Patient taken to UCI hospital via ambulance
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml Single-Dose Vial (SDV) (lot # L019297, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated; Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059068) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient had Covid-19 twice on Summer of 2022 and on June of 2023. This was after receiving Moderna vaccines. It wasn´t severe.). Concurrent medical conditions included Diabetes and Neuropathy.    On 02-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) and CONDITION AGGRAVATED (Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient received Spikevax 2 weeks ago and since then her neuropathy has been very exacerbated. She reported that she was certain that it was the vaccine because it has been worse since she had the vaccine. She experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it. But with this last shot, it was worse than ever, a lot worse. The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 68-year-old female patient, with relevant medical conditions of neuropathy and diabetes, who experienced the unexpected and serious (due to medically significant) events of Neuropathy and Condition aggravated, which occurred after SPIKEVAX 2023-2024 vaccine, administered as fourth dose within COVID-19 vaccination schedule. As reported, since she received the vaccine, her neuropathy has been very exacerbated. She experienced no other symptoms. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Underlying diabetes and neuropathy could be risk factors for the events. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2023-749436, MOD-2023-749438 (Patient Link).   Reporter did not allow further contact
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills and fatigue Narrative:  missed two day of work
I received the COVID shot and have been so sick; Sore throat; Sinus; Exhausted; Feverish; Dehydrated; Muscle fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 12:30 (Lot number: 30145BA) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 23Oct2021, outcome "not recovered", described as "I received the COVID shot and have been so sick"; OROPHARYNGEAL PAIN (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Sore throat"; SINUS DISORDER (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Sinus"; FATIGUE (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Exhausted"; PYREXIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Feverish"; DEHYDRATION (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Dehydrated"; MUSCLE FATIGUE (non-serious) with onset 23Oct2021, outcome "not recovered", described as "Muscle fatigue". The events "i received the covid shot and have been so sick", "sore throat", "sinus", "exhausted", "feverish", "dehydrated" and "muscle fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of illness, oropharyngeal pain, sinus disorder, pyrexia, dehydration, muscle fatigue. Therapeutic measures were not taken as a result of fatigue. No follow-up attempts are possible. No further information is expected.