chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L046318 with expiration date 28-SEP-2017, lot# M007125 with expiration date 06-OCT-2017, lot# M002252 with expiration date 28-FEB-2017, dose not reported) orally. The vaccines had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of rash in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, less than an hour after receiving Hepatitis B vaccine, the patient experienced rash and hives. On an unknown date, the outcome of the rash and hives were unknown. It was unknown if the reporter considered the rash and hives to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional declined to provide patient's date of birth. The vaccine was not administered by the reporting facility and was administered possible 20 years ago. The patient experienced a rash within a few minutes after receiving an unknown brand Hepatitis B vaccine. The patient's symptoms were described as a rash on the face, and trunk, and hives. No additional information was available.
RASH ON STOMACH, BACK ARMS, FACE ABOVE AND UNDER EYES.  TEQUIN 400 MG ONEC A DAY. ALAVERT, TYLENOL
really bad back pain down his spinal cord; really bad back pain down his spinal cord; headache; stiff neck; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Following receiving the vaccine, the patient experienced headache, really bad back pain down his spinal cord and stiff neck in May2021. He wanted to know if these were reported side effect of the vaccine and if he was having allergic reaction and if this was a medical emergency. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
About 8 minutes after receiving vaccine, patient asked for water and reported that he did not feel well. He reported feeling faint and slight shortness of breath. The pharmacy staff gave him water and advised him that he could remove his mask to assist with breathing and began to observe him closely. The patient began to fee l better almost immediately, and was asked to remain in the observation area a little longer in case of worsening symptoms. During the next several minutes the patient experienced two more brief spells of faintness, which were relieved with more water and deep breathing. The patient reported that he had been working out in the sun earlier in the morning and that he was possibly a little dehydrated when he came in for his vaccine. He said that the symptoms he was experiencing were similar to episodes of dehydration he had experienced in the past. After about 40 minutes of total observation the patient said that he was feeling fine and that he felt fine to leave and drive home on his own. He walked around the store for a few minutes to make sure he would not feel faint while walking, and then left the building. I called and left a message for the patient tonight, and will attempt to call again tomorrow morning.
A COUPLE OF HOURS AFTER RECEIVING THE HEP B VACCINE, PATIENT STATED HE SAW A "HALF-DOLLAR SIZE" REDDNESS DEVELOPE ON HIS TRIGHT DELTOID AREA. IT WAS RAISED BUT NOT WARM TO THE TOUCH.  HE ALSO STATED IT RESOLVED WITHIN 24 HOURS.
issues with my gall bladder; I felt a lot of pain in my back/ radiating throughout the lower back; reflux; fever; chills; I felt the usual rough day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER DISORDER (issues with my gall bladder) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESOMEPRAZOLE, LOSARTAN, HYDROXYZINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (I felt the usual rough day), PYREXIA (fever) and CHILLS (chills). On 27-Apr-2021, the patient experienced BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back) and REFLUX GASTRITIS (reflux). On 30-May-2021, the patient experienced GALLBLADDER DISORDER (issues with my gall bladder) (seriousness criterion hospitalization). The patient was hospitalized on 30-May-2021 due to GALLBLADDER DISORDER. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, GALLBLADDER DISORDER (issues with my gall bladder), BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back), FEELING ABNORMAL (I felt the usual rough day), REFLUX GASTRITIS (reflux), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Treatment medications included Muscle Relaxer. Action taken with mRNA-1273 in response to the drug was not applicable.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme symptoms of listed normal side effects. Extreme: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell. Temperature remains at 99.9-101.7 for 39 hours despite medication (tylenol, ibuprofen). At initial hours of symptoms (hours 1 - 8) patient was experiencing "hallucinations," extreme confusion, and anxiety.  Patient did not know where they were (at home in bedroom) thought they were somewhere else, and was also seeing things that weren't there for a period of a few hours.  "Hallucinations" have seem to subsided. Currently 101.7 temperature with extremely intense side effects listed above.
I received my first COVID-19 vaccine shot on 3/26/21. I started having rt. hip difficulty and IT band bursitis. I received my second shot on 4/23/21. For approx 8 weeks I suffered with severe joint pain and inflammation of my lymph nodes. General malaise that whole time. (Moderna Vaccine.)
Started feeling achy all over especially in hips and noticed a rash on her hands 6/1. Now she is covered head to toe in a red, maculopapular rash. The rash is warm to touch but patient is afebrile. The rash is itchy.
I had swollen lymph nodes in arm pits and neck, especially in the left collarbone area (about the size of an egg).  All the swelling went down in one down except for the large one above left collarbone, which took days to weeks to slowly go down. I called my doctor's office and they said that this was normal and they had received calls about this from other patients.  They said to call back if it didn't go down in 4 weeks and they would do an ultrasound but by that point it had gone down by itself.
Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.
fever of 103 chills body aches pain in legs and arms started at 3:00am the day after she received vaccine.  At noon on the day after vaccine a rash appeared on her leg which her dr diagnosed as shingles.
FACIAL FLUSHING, LIGHT HEADED, LACK OF COORDINATION OF EXTREMITIES. AFTER VACCINE INJECTION PATIENT WAS SITTING IN EXAMROOM AND SHE STARED TO FEEL VERY WARM AND GOT UP TO LEAVE THE ROOM BEFORE STAFF WAS AVAILABLE DEVELOPED A VASO VAGEL RESPONSE WHEN SHE TRIED TO WALK OUT THE EXAM ROOM DOOR. STAFF IN IMMEDIATE AREA PREVENTED HER FROM FALLING LYING HER DOWN AND ELEVATING HER FEET, COLD FACECLOTH TO HER FORHEAD AND GAVE HER SIPPS OF H20. AFTER ABOUT 15 MINUTE THE PATIENT STOOD WITH ASSISTANCE AND WALKED WITH ASSISTANCE TO AN EXAM ROOM WHERE SHE WAITED FOR A TOTAL OF 40 MINUTES. VITAL SIGN WERE RE-CHECKED AND REVIEW BY HER PCP. AFTER SOME MORE H2O AND CRACKERS. PATIENT STATED SHE FELT BACK TO NORMAL AND WAS WALKED BY A STAFF MEMBER TO HER CAR AND STAFF MEMBER REPORTED THAT SHE WAS DRIVING NORMALLY. SHE WAS DIRECTED TO  ACTIVATE EMS IF SYMPTOMS RETURNED.
40 yo M who received a flu shot on Friday and started having numbness in the L lower extremity. It moved to the R lower extremity and both extremities became progressively weak. The numbness and weakness also moved up towards his abdomen and he experienced urinary retention. The patient does not claim to have a history of reaction to flu shots in the past. The patient was subsequently started on treatment with IVIG 30g q24h x 5 days. PT/OT evaluations also noted for the patient.  Update: Spoke with the patient regarding the time and administration of the influenza vaccine. Per pt, he cannot remember when exactly he received the vaccine, but mentioned that he received the vaccine after a visit to the clinic and recalls experiencing weakness starting in his legs within a few hours of the vaccination. According to the urgent care RN, he visited urgent care clinic for a toothache on 12/7 and was seen by NP, but there was no documentation of an influenza vaccine administered or offered. On his records for another clinic visit on 12/9 for abdominal pain, it was documented that he had refused the influenza vaccine. No influenza documentation in his immunization record; last documented influenza vaccine in 2015. He completes IVIG course on 12/14 (total 5 doses, 30g) and is clinically improving. He is working with PT and is able to ambulate. Lower extremity strength has significantly improved.
More intense pain at shot site than in previous experiences with the ful shot.  Within 24 hours stiffness of the arm began.  I was struggling to lift the arm to reach things above my shoulder.  The next night I began having trouble sleeping due to pain.  The stiffness and pain increased as the days went on.  I tried over the counter Tylenol, ice packs, rest, but the pain continued and the arm became stiffer as the days went on.
Fever 101.4, headache, nausea for 3 days. Headcold, sneezing, dropping coughing started at day 4. Broke out in itchy, prickly rash at day 6. Head cold subsided. Rash still working itself out at day 10.
Report # 2001013861-1 described seizure-like activity in a "child" of unspecified age and gender who received Tetanus and Diphtheria Toxoids and Acellular Pertussis vaccine adsorbed (Infanrix). Allergies, medical history, and concomitant medications were not specified. This report was submitted directly to VAERS, also. On an unspecified date, the vaccine received a dose of Infanrix; it was not known whether the vaccinee had received previous doses of Infanrix. Subsequently, the vaccinee experienced "seizure-like activity". This report is considered SmithKline Beecham medically serious. As of 06/06/01, the outcome of the adverse event was unknown.  Follow up on 07/105/2001: "A seizure in a 3.5 or 4 year old vaccinee.  The vaccinee presented to the vaccine provider with no medical records, no possibility of obtaining medical records, and no known immunization history.  Therefore, the vaccine provider began a complete immunization series. On follow-up, the reporter stated that the vaccinee had received an initial dose of tetanus and diphtheria toxoids and acellular pertussis vaccine ("different manufacturer") on Oct 12, 2000. Reportedly, the family stated that the vaccinee had a gastrointestinal illness (NOS) the day prior to vaccination, although he had no sym ptoms the day of the immunizations.  On May 1, 2001, the vaccinee received the second 0.5 ml intramuscular dose of tetanus, diphtheria, adn acellular pertussis vaccine (Infanrix), the second 0.5 ml intramuscular dose of hepatitis B vaccine (brand unspecified), the second dose of 0.5 ml intramuscular dose of Haemophilus influenzae type b vaccine (brand unknown), the second 0.5 ml intramuscular dose of inactivated poliovirus vaccine (IPOL, Aventis Pasteur), a 0.1 ml intradermal dose of PPD (purified protein derivative) and the second does of 7-valent, pneumococcal conjugate vaccine (Prevnar, Lederle Labs). A "few hours" later, the vaccinee experienced a seizure and was taken to the local emergency room.  All tests (NOS) performed at the emergency room were "negative".  Seizure is considered GSK medically serious. The reporter indicated that the seizure was possibly related to Infanrix. The reporter also indicated that the seizure could be associated with possible mild dehydration. As of Aug 7, 2001 the seizure had resolved.  As of 06/26/2001, the outcome of the adverse event was unknown."
overall weakness in body, nausea, vomiting, eye pain,extreme pain at the site, headache, fever
feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a contactable consumer (patient herself). This 27-Year-old female consumer reported for herself that received BNT162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and expiry date Unknown) via an unspecified route of administration in left arm on 08Mar2021 16:30(at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included depression and anxiety. Patient was allergic to zyrtec, adhesives. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol, norgestimate (ESTARYLLA), doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]), Ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines in 4 weeks. On 09Mar2021 08:15 (Timeframe between vaccine start and event onset date was 15 hrs 45 min) patient experienced feel very tired, some pain at the injection site, and feel very thirsty. Therapeutic measures were not received as a result of adverse events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient received vaccine in the morning 3/6/2021.  In the evening, patient developed multiple episodes of profuse diarrhea.    She did become lightheaded, fell, and 'broke my tailbone.'      She did see a family medicine physician 3/8/2021 - patient did pass out per the note but did not hit her head.   +camps  -nausea -emesis   No known contacts to anyone with illness or diarrhea
2 days after receiving vaccine employee experienced numbness and tingling in feet which worsened with rest and improved with waling.
The patient is a 29 year old male. 29 yo man given yellow fever vaccine at 3:30pm-started to feel sl unwell - then developed rash on forehead a few hrs later and felt sl tight in chest/achy/ sl stuffy in throat - left eye also became injected - had also has typhoid/ Hepatitis b and flu vaccine 2 days ago (has had these in past w/o difficulty) - never had yellow fever vaccine in past - no egg allergy - has some mild seasonal allergies but this feel different - no wheezing/hives/fever possible allergy reaction to PCN as a child.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment was given from 28Feb2023 to 04Mar2023. Adverse event Rebound on 10Mar2023 02:00 PM and the patient was not recovered and No treatment received. Other medication in 2 weeks was Unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea and dizziness starting 20 hours after vaccination lasting for more than 4 hours.
On 2/27/03 PT noted small dried spot above upper lip (Hx of "cold sores") Vesicular lesion on right forearm. Cultures done and sent to state lab. PT sleeps with vaccinee and puts her arm around his (vaccinated) arm during sleep.
Shingles outbread - Back of head in hair and on neck, top of both legs (front); under both arms; under both breasts and left ear. Second outbreak - 4 - 5 days after second dose, same areas. Now left with eczema at all sites.
Arm pain at injection site was the first.  The pain intesified the remainder of the day and continued for 3 days.  My arm swelled Thursday night, the night of the shot.  It was difficult to sleep Thurs and Fri nights.  As of today, 3 days after the shot, my upper arm is still swollen and now numb.  It was a little numb and tingly yesterday.  I, also, have no energy at all today and keep getting dizzy.  Arm does still hurt today too. Bending my arm at the elbow is fine, but it is very difficult to use shoulder movement.
Patient received 1st dose of Moderna vaccine on 2.27.21. Patient describes urticaria/itching round 2 weeks after receiving first vaccine.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
"Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Patient was in his usual state of good health prior to Dec 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around November 2010. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia, and an approximately 15-pound weight loss over ~ 30-day period. Around 10 Dec 2010, pt also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and Ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, pt has been followed through a local Endocrinologist, as well as local medical providers. PtM received FLUMIST vaccine in Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Pt does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Pt reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM.
seizures after receiving first dose of GARDASIL 9; This spontaneous report was received from a nurse prescriber (also reported as physician) via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot number and expiration date were not reported) for prophylaxis.  After receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced seizures. The outcome of the event was not reported. Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.    Upon internal review, the event seizures was determined to be medically significant.
One day after receiving H1N1 vaccine, pt began to develop a fine red itchy rash all over his limbs and trunk. He is using BENADRYL cream to control his symptoms but rash is spreading.
? SEIZURE, PT FOUND LYING ON FLOOR DOESN'T REMEMBER WHAT HAPPENED, VITALS TAKEN NEURO ASSESSMENT WNL. FELT NAUSEATED AND HAD A HEADACHE. REPORTED LATER THAT NIGHT THAT HE HAD 2 MORE SEIZURES BY JAIL STAFF. AMBULANCE CALLED FOR ONE AND CHECKED PT. OVER AND DID NOT FEEL THE NEED TO BRING HIM TO HOSPITAL. FOLLOWED UP WITH HIM ON 8/2/2021 HE HAS HAD NO FURTHER SEIZURE ACTIVITY AT THAT TIME AND NO NAUSEA, VOMITTING OR HEADACHES.
Information has been received from a registered nurse concerning a 52 year old female with exercise induced asthma and allergies to penicillin and sulfonamide who on 11/16/05 at 2:30pm was vaccinated IM, into the left deltoid, with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). Concomitant therapy included influenza vaccine (lot U1827AA) given IM into the right deltoid. On 11/16/05, shortly after the vaccination, the patient developed redness, warmth, swelling and pain at left deltoid injection site. The patient visited the ER due to the pain but no treatment was required. Follow up reported that the patient sought medical attention via a doctors visit and the patient was treated with unspecified antihistamine and antibiotic. The patient recovered within 2 weeks. The reporting registered nurse considered redness, swelling, warmth and pain at injection site to be other important medical events (OMIC). Additional information is not available.