chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHOT RECEIVED 8:45 A.M. AT 9P.M. BROKE OUT IN RASH ON TRUNK, ARMS,NECK,SCALP. WITHIN AN HOUR, HAD WHELPS ON NECK AND EAR LOBES WRER SWOLLEN. ALSO, FELT LIKE INNER EARS WRER SWOLLEN. CALLED MEDICAL DR., WHO TOLD ME TO TAKE BENADRYL 50 mg TID FOR NEXT 3 DAYS. ON SUN. I CALLED THE DR. AGAIN SINCE SYMS WEREN'T SUBSIDING. WAS ORDERED A MEDROL DOSE PACK. TODAY (WED) I STILL HAVE RASH JUST UNDER THE SKIN AND HAVE EPISODES OF ITCHING AND SKIN CRAWLING AT TIMES.
she was sleeping; dizziness; she said that she had a reaction that scared her; She was sleeping and she got dizzy and felt like she was going to fall; She said that she had nausea.; She said that she felt very cold and felt her heart beating; She said that she felt very cold and felt her heart beating; Headaches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included she was on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient's concomitant medications were not reported. On 24Jan2021, she said that she had a reaction that scared her, she said she was sleeping and felt dizziness. She was sleeping and she got dizzy and felt like she was going to fall. She said that she thought she was dreaming at first until she opened her eyes and realized that she was still dizzy. When she opened her eyes, she still felt dizzy and it wouldn't go away no matter which way she looked. She states dizziness has resolved. She also reports having nausea. She said that she felt very cold and felt her heart beating. She said that everywhere that she turned her head she would get dizzy, even when her eyes were open or closed. She is on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient was also receiving radiotherapy treatments. She was scheduled for hormone treatments starting 9Feb2021. She has Zofran for nausea and told her doctor about what happened and her oncologist told her to take Tylenol for headaches, but she said that she did not have a headache. She said that the Zofran relieved the nausea, but she still had the dizziness. She said that every movement would cause dizziness. She said that she was wondering if it is safe for her to get the second dose. She states that she does not take immunosuppressant medications. The outcome was unknown.  Information on the lot/batch number has been requested.
No adverse reactions noted; HBP calling to report AE for patient that received both PROQUAD and VARIVAX.  No adverse reactions noted.  Associated AE's: 02507181//02507145 No PQC.; This spontaneous report has been received from an administrator, regarding a neonate patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-OCT-2023, the patient was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: X010526, which was determined to be valid, with an expiration date on 11-APR-2025), in combination with a single dose of (PROQUAD) injection (lot number: X018730, which was determined to be valid, with an expiration date on 06-JAN-2025), both as prophylaxis (overdose).  No adverse reactions were noted.   This case is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004439: US-009507513-2311USA004323:
patient received improperly stored vaccine/ Temperature excursion 48.4F; No further information  is available; This spontaneous report was received from a physician concerning an unspecified age and gender patient. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not reported.  On 28-JUN-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe as prophylaxis (lot number T035379, expiration date 31-MAY-2022, which were determined to be valid) (route and anatomical location of administration were not reported).   The involved vaccine was exposed to a temperature excursion of 48.4 grades Fahrenheit (F) for 25 hours and 29 minutes, as recorded by a data logger (product storage error) (unspecified date). There was not a previous temperature excursion. No further information was available (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Initial case received from a health care professional on 20 April 2010. It involves a case of misuse (i.e. inappropriate age at vaccine administration). A 10-year-old boy received a right arm intramuscular injection of ADACEL (Sanofi Pasteur Inc lot number U3052BA, Sanofi Pasteur Ltd lot number C3311) and an intramuscular left arm injection of VAQTA (Merck, lot number 02647) on 19 April 2010. The morning after vaccination, the patient developed a macular-papular rash on the arms and trunk. The patient had no relevant medical history, was not taking any medications, and was not ill at the time of vaccination. At the time of the report, the event had not recovered.
Onset of symptoms occurred within a minute of having the vaccine administered. Symptoms included heart racing/palpitations, profuse sweating,  sudden lack of vision and hearing, on the verge of fainting.
LIGHTHEADENESS, DIZZINESS, DECREASE IN HEARING, LOC ABOUT 2-5 MINUTES, UNSURE EXACT AMOUNT OF TIME. STATED SHE ATE, DRANK FLUIDS, WENT TO SLEEP A COUPLE HOURS AND WOKE UP WITHOUT SYMPTOMS.
This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SOTALOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
w/in a few hrs of vax pt had a terrible tantrum, banged head, screamed a very long time;later had a staring spell, arched back & was non-responsive then seemed all right;next day had a fever of 104
Several hours after vaccination I began to experience significant ringing in my ears. This continued until the 4th day when the ringing became more of a humming sound and there seems to be a decrease in volume that can be heard with the left ear. There was also a sensation of the ears being plugged up.
RN, from specialty medical staffing agency came in to assist with COVID vaccine administration on 2/26/21. While administering vaccine, RN had difficulty injecting medication inside patient's arm and the needle was removed, changed and injected each time for a total of three times to inject vaccine into patient's arm. Due to multiple injection injuries, pharmacist contacted patient within 24 hours of injection to monitor injection site reaction and monitored patient's reaction for 72 hours after injection. Patient didn't report additional injection site pain 72 hours after injection.
@ time of inj pt stated felt pressure;pt stated had pain in lt arm;pt stated pain radiated from shoulder to elbow of the lt arm;
This study case was received from the investigator in a trial on 18 April 2011. A 20-year-old male subject, with no significant medical history, developed non-specific myocarditis 29 days after receiving an injection of ACAM2000, lot number not provided, on 15 June 2010. On 28 June 2010 the subject had an abnormal troponin I blood test of 00.51 and an abnormal electrocardiogram (ECG). The subject was diagnosed with non-specific myocarditis on 14 July 2010. On 20 July 2010, the subject's echocardiogram was reported as normal. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Info has been received from a health professional concerning a 25 year old female with a history of appendectomy who on 12/17/01 was vaccinated with the 1st dose of Hep-B. There was no concomitant medication. On 12/19/01, the pt experienced red dots on her upper thigh, abdomen, shoulder and cheek. She recovered from the dots. In 1/02, the pt experienced generalized itchy skin. The pt sought medical attention. Additional info has been requested.
eye and vision damage; vision damage; scarring; shingles outbreaks/numbness in her left leg/Pain and tingling sensations in her skin,; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On 11-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         At the beginning of January 2018, the pt experienced many shingles outbreaks causing to the pt tremendous pain, scarring (scar) and also eye (eye injury) and vision damage (visual impairment). These injuries were caused by zoster vaccine live (ZOSTAVAX). Then, the pt continued having reoccurring shingles outbreaks including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensations in her skin were permanent and continued until reporting time. As a direct and proximate result, the pt's symptoms had resulted in physical limitations not present previously. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. Also, as a result, the pt sustained severe and disfiguring personal injuries. Additionally, as a tragic consequence, pt suffered serious, progressive and incurable injuries, as well as significant conscious pain, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages.  At the reporting time, the pt was not recovered from the adverse experiences. The events were considered to be disabling.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced abdominal pain (intermittent abdominal pain), with outcome of unknown. Additional information: Patient and his son were experiencing intermittent abdominal pain, which "comes and goes." He asked if he should go to the emergency room, or it was a commonly reported adverse event. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Hours after the dose: right arm tingle and soreness, hard to lift objects with that arm. Next morning: Total body Soreness (neck to legs) and some feverish chills began, not strong enough to stop activity Sunday 7/25: Soreness/chills felt like they were going away Today 7/26: Total body soreness and chills returned stronger, hard to get out of bed/walk without shaking too much or having to stop because of pain.
Patient developed 1 hive on inside of left wrist. She had no other symptoms and the hive resolved with in 2 hours.
PATIENT WAS GIVEN A FLU SHOT AROUND 1:15 PM ON 11/10/17. ABOUT 30 SECONDS AFTER VACCINATION, PATIENT FAINTED ON THE CHAIR, SKIN LOOKS PALE, AND HAD SOME JERKY, ABNORMAL MOVEMENTS. OFFERED TO CALL AMBULANCE BUT DAD DECLINED. ACCORDING TO DAD, SIMILAR EVENT HAD HAPPENED BEFORE WHEN SHE HAD IMMUNIZATION OR BLOOD WORK DONE. DAD MENTIONED IT WAS LIKE VASOVAGAL FAINTING EPISODE. BLOOD PRESSURE WAS 107/58, PULSE 63 WITH BLOOD OXYGEN SATURATION OF 99%. PT WAS GIVEN ORANGE JUICE AND WAS OBSERVED IN THE CONSULTATION ROOM FOR 20 MINUTES UNTIL MOM ARRIVES, THEN BOTH PARENTS CARRIED PATIENT OUT OF THE PHARMACY. PHARAMCIST INFORMED PATIENT'S PEDIATRICIAN. RPH FOLLOWED UP WTIH FAMILY MEMBER 1 HOUR AFTER THE EVENT, PT WAS HOME WITH BOTH PARETNS RESTING.
Approximately 24 hrs after receiving a shingles shot pt. called us complaining of rash/swelling at injection site. When rash had not improved by the second day the pt. saw her physician and was given several prescription to treat the rash (topical/oral steroids and antibiotic cream).
On 1/10/2021 I got vertigo  & I've never had that before.  I had 103 fever, chills, headaches, body aches & dizziness it felt like the room was spinning. On the following Wednesday I called my doctor & he prescribed me anti nausea medication. By the 8th day I was fine.
body aches; Shortness of breath; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician and nurse via sales representative.  This case is linked to cases 2019SA280603 and 2019SA280605 (same reporter).  This case involves a 91 years old female patient who experienced shortness of breath (dyspnoea) and body aches (pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included flu shots without any reactions. The patient's past medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed shortness of breath (dyspnoea) and body aches (pain) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events. It was reported that the hospital personnel stated it was due to flu shot.  Other relevant tests not reported.   Final diagnosis was body aches and shortness of breath.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for shortness of breath and body aches.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case concerns a 91 years old female patient who developed dyspnoea and body pain after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical condition at the time of vaccination was not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Full body muscle aches, headache, neck stiffness, shivers, nausea, temperature registered at 101 degrees. Took ADVIL PM. Didn't get much sleep. Took regular ADVIL in this morning (8/17), symptoms improved as the day went on. Still have some back pain and pain at injection site (expected).
Employee stated that approximately 3 hours after receiving the vaccine she began itching at the injection. She further stated that upon taking the band aid off, she noticed that there was swelling and warmth at the site, as well as pain and increased itching. As the night progressed (approximately 16 hours after the vaccine was given), she began to have night sweats and fatigue. The employee reported to the occupational health clinic with area (approximately 65" x 55"), noted with erythema and warmth, and continues to complain of itching, fatigue, weakness, and no pain unless the area it touched.
One hour after I got dizzy, very hard to walk, hard palpitations, extreme muscle fatigue (still going on), High blood pressure.   I went to see the doctor. Doctor said there is nothing they can do because they don't have any info about the vaccines.
Foster mom reports 2" redness and 1" diameter lump in area of IPOL site. LA SQ. DTaP given in Left deltoid.
Patient received vaccine on 10/2/13 and presented to hospital on 11/16/13 with weakness and a fall. Patient noticed weakness in his hips and tingling in his toes and fingertips. Neurology evaluated patient and diagnosed him with Guillain-Barre. Patient was treated with 5 doses of IVIG.
She reported chills and fever of 103 at 3 am 07/26/02 -Fever continued until 07/27/02. Fever broke Sunday 07/28/2002. Client called HD on 07/29/02 to report reaction.
serious UTI; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (serious UTI) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced URINARY TRACT INFECTION (serious UTI). At the time of the report, URINARY TRACT INFECTION (serious UTI) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller said he received his 1st shot of Moderna COVID vaccine on 6th Jan 2021 and on 17th Jan 2021 he had to go to hospital , tested for COVID got negative and diagnosed with serious UTI and the doctor gave him iv antibiotics and prescribed some oral antibiotics, he is still feeling pretty sick, but his got tested yesterday (20Jan2021) and informed by his Doctor that his UTI is resolving. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
DTAP ADMINISTERED ON 9/15/08 IN PATIENT'S LEFT THIGH DURING ANNUAL CHILD PHYSICAL. PATIENT CAME BACK TO THE OFFICE ON 9/18/08 WITH AN 8cm SWOLLEN RED SPOT AT INJECTION SITE.  PT REPORTS THAT IT WAS SOAR AND ITCHY.  GRANDFATHER OF PT REPORTS THE AREA BECAME RED AND SWOLLEN ON 9/17/08.  PT GIVEN WESTCORT CREAM FOR ITCH RELIEF.  REPORT OF VACCINE INCIDENT GIVEN TO VACCINE REP FROM GLAXO SMITH KLINE ON 9/18/08.
Donor c/o itching and had a rash the approximate size of a 50 cent piece on lt side of lower back also c/o lower back pain.
Patients mom called back later in the day to report redness and swelling  of about 6cm at the injection site. No Fever but has been taking Tylenol. Area is sensitive to touch and he is fussy.
Pt. received vaccine Feb 1st late pm. Within 24 hours pt. experienced swelling at the lower left jaw line. Pt. reports pain upon touch and difficulty opening his mouth.
Dose was administered outside of BUD on labeled product- dose was determined to be valid by Moderna
Starting slurring speech, right arm went numb and right side of face was not responding.  Went to ER and they confirmed he was having a stroke.  Continued to have multiple strokes at ER from 8:40pm last one was 1:30am (4 hours after clot buster given).  Cause of stroke is still undetermined no clots found, no high blood pressure and no high chlorestrol.
Administered vaccine intramuscularly to the right arm.  Immediately swelled up in a raised round lesion (within 30 seconds) after administration.   Bandaid applied.  Raised to 1 cm above rest of arm.  Negative to pain, difficult breathing, itchiness etc.  Had them sit ... refused ice  to wound at store... after 10 - 15 min family requested to leave.... usually we ask to have them observed for 30 minutes.  Swelling had subsided  to ~ 1/3 centimeter or so above the skin... no other symptoms.  Counseled for signs of anaphyalxis and rebound sx.  Called approx an hour later.... spoke to daughter. ... pt had improved.   No anwser 4 hours later.  Called next in the evening and pt had fully recovered as per daughter
swollen ankles due to her arthritis; This is a spontaneous report received from a contactable reporter (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: REPAGLINIDE taken for diabetes mellitus. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "swollen ankles due to her arthritis". Therapeutic measures were taken as a result of joint swelling.  Additional information: ADVIL was taken as treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client reveived Zostavax vaccine on 8/3/07 at 8:40 am.
mild fever onset about 8 hours after vaccine administration - continued to rise despite Tylenol - reached as high as 103 degrees, even at peak time of Tylenol dose. resolved at approximately 24 hours.