chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up the next morning and while sitting up I went into a horrible vertigo reaction. My world was spinning so bad I thought I was gonna die. Started throwing up and could barely make it to the bathroom. Had Severe diarrhea and constant regurgitation.Also a severe headache came as the day went on.  My husband had to carry me to the restroom. Finally  by that afternoon he put me in the car laying down in the back seat to the hospital. I finally after 3 days or so tried to take a shower and sat in the shower and my body was itching like crazy. As I got out of the shower my husband noticed a rash all over my body. I think because of the medication for the vertigo I was taking I didn't really feel the itch as bad..
7AUG98 pain lt leg/body aches;no fever;9AUG98 swelling of hand/fingers w/aching;10AUg98 pain lt arm/hand seen @ ER;11AUG98 returned to ER for pain;dx rxn to MMR;seen in ER for pain, vomiting;
This case was reported by a healthcare professional and described the occurrence of an unspecified adverse event in a 8-year-old subject of unspecified gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event.  The outcome of the event was not reported and no additional details regarding the event were provided.  This was also considered to be a maladministration.  FLUARIX is not indicated for use in children.
FEELING  LITTLE TWINGES IN ANKLE; MUSCLE SPASM IN ANKLE; SWELLING IN ANKLE; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 64 year old female. 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: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 in the morning around 09:00-10:00 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAY-2021, the patient got a deep vein thrombosis. On 20-MAY-2021, the patient went to physician who scheduled an ultrasound on 26-MAY-2021, to verify the deep vein thrombosis and patient got those results that same day confirming the deep vein thrombosis. On 27-MAY-2021, the patient started treatment medication Xarelto and was on 15mg twice a day for 3 weeks, then 1-20mg pill daily through last Sunday, 26-SEP-2021. On 03-OCT-2021, patient felt like it was coming back. On the same day, patient was feeling little twinges/muscle spasms and had sharp ones at afternoon in ankle the area where patient had the deep vein thrombosis. Patient had swelling in ankle which also started on 03-OCT-2021 in the same place had it before and still has on. The twinges come and go. The patient would call physician on 04-OCT-2021. Patient stated that, the vaccination facility did not put a lot number on vaccination card. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in ankle, and the outcome of deep vein thrombosis, feeling little twinges in ankle and muscle spasm in ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211007109-Covid-19 vaccine ad26.cov2.s- Deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Child developed Shingles on belly, hip and down the left leg to the knee.  Rash cleared in 2 weeks, but post-herpetic neuralgia is ongoing.
pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax; inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/vax
suspected vaccination failure; still got them bad; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Redness, itching, swelling, hot to touch. Resolved 03/23/2021. Given antibiotic by PCP.
At 5:45 PM  on 1/6/21 the same day I received the vaccine I had a fever of 100.5, F, headache, chills, and severe pain at the site of injection.  After one dose of 650 mg acetaminophen my temperature went back down to 98.6 F. The next day 1/7/21 I did not have a fever; I still had mild chills and headache and pain at the site of injection. For the pain I took 1,000 mg of acetaminophen at morning and at night which eased the pain. The following day 1/8/20 I did not have headache or chills and had very mild pain which was tolerable.
Case number PHEH2014US002828 is an initial spontaneous report received from a health care professional on 06 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The reporter stated that the doctor while administering MENVEO (batch number: A13058), the needle came off the syringe and splashed back to the doctor's face on 06 FEB 2014. IT was reported that the vaccine almost exploded back to the doctor's face. Some of the vaccine went into her mouth and she spit it out and some went into her eye. No adverse seven was reported following the medication error.
Information has been received from a physician concerning a patient (age and gender not reported) who, on 15-AUG-2007, was vaccinated with Zostavax (Oka/Merck, Lot #657676/0619U) in the left deltoid.  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently, on 19-AUG-2007, the patient developed shingles on the left lower medial arm.  In follow-up it was reported the patient had no recent exposure to chickenpox or herpes zoster.  No direct fluorescent antibody was performed.  no specimen was collected for PCR, and not photographs were taken.  The patient also experienced a headache.  The patient outcomes were not reported.  Additional information is not expected.
Two hours after injection had a hot burning feeling throughout entire body for appx. four hours.  At 1100pm started chilling and aching.  At 4am became nauseated and fever was 102 degrees.  Nausea and vomiting and diarrhea continued until appx 2pm with fever.   Was able to take Advil at 4pm  which reduced fever throughout the night.   Sunday morning felt fine but by noon had nausea and some vomiting again.  By 2pm was aching chilling again and fever was around 99.6.  Advil relieved the fever.  This is Monday morning, April 5th and feel fine this morning.
Headache, Myalgia, felt warm-feverish Narrative:  Taking OTC NyQuil every 4-6 hours.
Earlier in the week, I tweaked my back.  That day and every day up and including my Moderna vaccine booster I was well on my way to recovering from sciatica.  In fact, I needed no pain meds and only took Tylenol and Advil while continuing to walk several miles per day, doing 80-100 bodyweight squats (full range of motion), and doing pilates work on a reformer.  Thursday after the shot, I barely could get out of bed and I couldn't walk very far without assistance.  By Saturday I could not sleep because of the pain.  Sunday, I was in such bad shape that I laid on the floor of the bathroom for 5 hours finally giving up and calling the ambulance.  At the ER I had a dozen or so rescue doses of Fentanyl, Morphine, and Valium.  None of them took away the pain.  I didn't sleep that night and I was unable to get an MRI unless sedated.  Finally, by Tuesday I slept and the pain decreased.  I feel that I'm well on my way to recovery but I've never experienced such pain and I have been stabbed, shot, broken bones, knocked out, 2 back surgeries, and 3 sinus surgeries.
Approximately 10 minutes after receiving the vaccine, patient c/o of sharp pain radiating from the left shoulder to the lateral side of the neck - pain.  5/10 - Vitals taken, all WNL , denies any SOB, nausea, vertigo.  Continued to monitor , vitals retaken
10/24/2021 1800: Onset of fatigue, muscle aches, fatigue, headache, loss of appetite. Onset of chills at 2000.  10/25/2021: Severe headache, muscle pain, malaise, fatigue, nausea. 10/26/2021: Headache, ocular pain and blurred vision (R eye) and tinnitus in L ear.
Fatigue, Headache, myalgia, mild joint pain, extreme right deltoid muscle tenderness
4-5" area around injection site developed: swelling, redness and heat. Patient felt "fuzzy and out of it" with "difficulty focusing".
Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included AMLODIPINE, ATORVASTATIN, BACLOFEN, CITALOPRAM, CLONAZEPAM, MAGNESIUM, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), LOPERAMIDE HYDROCHLORIDE (IMODIUM) and VITAMIN D NOS for an unknown indication.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Symptoms: The patient did not experienced any symptoms, The medical assistant confirmed that only one patient received expired dose and the vial was initially stored in the refrigerator on 13-Sep-2021 and it did not went under any temperature excursions.
Migraine started after injection 7/28/08 & intensified. Unable to get out of bed for next few days, had body aches & dizziness x6 days.  Went to urgent care informed "probable reaction".
Pt recvd 3rd dose in series of Engerix-B & on 28MAR91 Hep B immune titer indicated no immunity; Pt also receiving Motrin for knee & back pain;
slight tremors; waking up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Generalized anxiety disorder, Hypothyroidism and Insomnia disorder (The patient had trouble sleeping and waking up in the middle of the night.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night). At the time of the report, TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient was taking Klonopin at night to relieve the symptoms.
The patient experienced light-headedness and almost fainted. She sat down on the floor and put her head between her knees. We  had her sit in pharmacy area for further observation for about 30 minutes and she covered with no problems.
This spontaneous report as received from a consumer refers to his 11 year old daughter. The patient's pertinent medical history and concurrent conditions were not provided. On 10-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. Since the evening of 10-AUG-2016, the patient had been experiencing severe musculoskeletal pain in both her shoulders. No treatment was given to the patient. The patient did not seek medical attention. At the time of the report, the patient had not recovered. The consumer did not assess the relationship of the event to GARDASIL 9. No product quality complaint was involved on this case. Additional information has been requested.
I've had left side arm and shoulder soreness/stiffness since the vaccine 4 weeks ago.
10/17/2010: HA, Malaise, Chills, Fever 103.4, joint pain, rash, itching, SOB (used albuterol inhaler, took 800mg ibuprofen) 10/18/2010: fever 101 aches, chills, HA, malaise, nausea/vomiting (took ibuprofen and Tylenol) 10/19/2010: HA with photophobia, nausea, vomiting (took Aleve) 10/20/2010: HA with photophobia, neck pain/stiffness, nausea/vomiting (went to urgent care received phenergan, sumatriptan, vicodin.  10/21/2010: nausea/vomiting  10/22/2010: no symptoms
This pleasant 70-year-old female presents with feeling poorly headaches and momentary loss of consciousness with confusion and at with test seizure x1---more detailed history per attending physician, is verified and reproduced below        Tested positive on 10/03/2021 Presents with 70 year old female with a history of hypertension,  hypercholesteremia presents to emergency room complaining of not feeling good for the past few days.  Patient reports that she has been having intermediate episodes of headache.  Patient reports that this morning she did not feel well after getting up.  Spoke with patient's husband which reports that she was sitting down on the sofa and became stiff, eyes rolled back and unresponsive for few seconds.  Patient came into the emergency slightly confused.  The onset was just prior to arrival.  The occurrence was single episode.  Witnessed: yes.  The location where the incident occurred was at home.  The character of symptoms is Eyes rolled back and body tensed up.  The Postictal symptoms is confusion.  The exacerbating factor is none.  Risk factors consist of.  Therapy today: none.  Pregnancy symptoms none.  Associated symptoms: headache.  Associated injury: none.    [1]
Res not feeling well this shift, very weak and tired. Res having minimal output and has been to the bathroom x1 today.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (rash). The patient was treated with HYDROCORTISONE for Rash, at a dose of UNK dosage form. At the time of the report, RASH (rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Approximately a week later to the vaccination, the patient developed a rash, he still has it on his upper chest, it is going away very slowly at the time of report.
Red swollen itchy 3" circle at injection spot started 1 week after first dose. Lasted approx 48 hours
Wrong diluent used. A sterile solution diluent was used in error to mix/reconstitue vaccine with.
NO ADVERSE.  Reporting administration error only.  Patient received Pfizer Bivalent 12+ as a primary dose.  No adverse effect during standard 15-minute observation period.
VERY DIZZY DAY AFTER 2ND VACCINE.  HEADACHE ALL DAY.  FELT LIKE SOMEONE SPRAYED MY MOUTH WITH SOME TYPE OF CHEMICAL.  ABOUT 12 HOURS AFTER SHOT GOT THE CHILLS.
Severe, painful abdominal cramping, sweating, and pooping. Felt like childbirth. So painful it was difficult to hold back tears or regulated my breathing.  A lot like a severe "spastic colon attack". 2 1/2 hrs later, a dozen or so toilet flushed and it's not over with yet!
Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruation period with severe multi-day cramps; Fluid in the ears causing dizziness and elevated blood pressure; Fluid in the ears causing dizziness and elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). This 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 at 14:45 (at age 52-years-old) as a single dose for covid-19 immunisation. Medical history included facioscapulohumeral (FSH) muscular dystrophy from an unknown date and unknown if ongoing and drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; and metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps. The adverse events resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure measurement (30Mar2021): elevated. Therapeutic measures taken included unspecified medication. Clinical outcome of the events fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician refers to a 3 month old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 19-FEB-2015 the patient was vaccinated with his first dose of ROTATEQ (lot# reported as K010222, expiry date dose unspecified) orally. No concomitant medication reported. On 20-FEB-2015 (reported as "about 1 to 2 days" following the administration), the patient began to produce stool that smelled like metal. The outcome of the event was not resolved at the time of report. Patient sought medical attention via phone call to physician's office. There was no treatment given for event and no lab diagnostics studies performed. No product quality complaint (PQC) was involved. The reporter did not assessed the relationship between ROTATEQ and the event. Additional information has been requested.
No additional AE reported; patient was given a dose of V AQTA that expired in October 2020; This spontaneous report has been received from a physician and refers to a 18-year-old patient of unknown gender. No information regarding the patient's concomitant therapies, medical history and drug reactions or allergies was provided.  On 22-JUL-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) that expired on an unknown date in October 2020 (dose, route of administration and lot # were not provided), for prophylaxis. No previous temperature excursion occurred. No adverse events were reported.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-AUG-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N029631, expiration date: 23-OCT-2019, dose and route of administration were not provided) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced temperature excursion between 6 and 14 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Localized reaction at injection site. 5 cm x 4 cm red, swollen and hot.
Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old male patient who received first dose of IMOVAX RABIES on 07-Jun-2018 and had a second dose of vaccine lot 966650, expiry date: 26-Feb-2019 in the left deltoid on 08-Aug-2018, that was considered the first. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown whether the patient had any adverse event. 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 Directive and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Information has been received from a RN concerning a 12 month old male with no known allergies who on 02/15/99 was vaccinated IM with a first dose of MMRII. There was no concomitant medication. On 03/01/99, two weeks following vaccination, the pt developed a rash all over his body which lasted for one week. The pt took Benadryl and the rash "disappeared". It was noted that the pt sought medical attention. No additional information was available at the time of the report. No additional information is expected.
Patient received a dose of pneumovax23 on 11/29/2022; She received another dose on 2/10/23. On 2/11/23 she started experiencing pain, redness and muscle tightness (says unable to move the arm) and the symptoms continued after. she says it doesnt seem to be getting worse but is not getting much better either.