chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe tinnitus, variable throughout the night, louder than the train horn 4 blocks away. Severity slowly lessened the next day, by evening June 2 it was at the steady state level it is still at now, 2 weeks later. It's extremely distracting and reduces my ability to focus or think clearly. I have a purely thinking job and this is an extremely disruptive and productivity reducing level of sound.  Related but not what is being reported: Fever of 103F from about 7pm (6 hours after injection) to early morning. Down to 101F by 8am. 400mg ibuprofen taken at 9pm.  I've never had any negative reaction to any other vaccine before.
multiple outbreaks of herpes zoster; scarring; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, resulting in scarring. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events multiple outbreaks of herpes zoster and scarring were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events multiple outbreaks of herpes zoster and scarring to be disability.
Major joint pain throughout body for 3 days duration.   Customer reported difficulty using stairs, walking, getting out of bed, getting off the toilet.   Customer did not take tylenol or ibuprofen during this time.
Myalgia PAIN, DISCOMFORT, NAUSEA, HEADACHE Narrative:
This spontaneous report as received from a physician refers to 2 unspecified patients. On an unknown date the patients were vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date, following vaccination of GARDASIL the patients fainted. At the time of the report the outcome for the patients was unknown. This case is linked to MARRS 1307USA009233 and 1307USA010389. Additional information has been requested.
TWINRIX given in error. Client had 3 doses of Hep B prior to visit on 10/13/16. Client should have received Hep A - single antigen client notified to come in for Hep A vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive with symptoms 3 days after negative test; Positive, notes: Tested positive with symptoms 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medications in two weeks. Patient had tested positive with symptoms 3 days after negative test. Patient had not known allergies. Patient was administered Paxlovid for ae treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer Dose 1 4/15/21 (EW0153) Pfizer Dose 2 5/7/22 (ER8736) Pfizer Dose 3 8/14/22 (lot NA) COVID Postive 2/3/22  2/2/22: Patient is 63-year-old male with history of kidney transplant in 2018 on prednisone, mycophenolate, and tacrolimus , insulin-dependent diabetes mellitus, presented to the emergency department with a complaint of burning epigastric abdominal pain nausea, and vomiting with poor oral intake of 3 weeks duration.  Patient reports that symptoms started 3-4 weeks ago, symptoms are pursue stent, he has been having epigastric and substernal burning abdominal pain that is constant described as reflux, he has been nauseous and vomiting at times, reports that vomitus is bloody, reported black tarry stool, reported very poor oral intake for the last 3 weeks, poor urine output. Denied any history of bleeding in the past, he is not on any blood thinners and takes only low-dose aspirin, denies excess alcohol use, no recent illness fever or chills.  In the emergency department, Patient was with sinus tachycardia, slightly hypertensive, lab work showed CO2 of 12 in 17 on repeat, blood glucose of 303 but with normal pH and no concern of DKA, creatinine 3.9, lipase of 32, troponin of 0.04, hemoglobin 12, platelets 90 K, patient was given 2 L normal saline.  ED provider discussed accepted the patient as level to but expect bed to be available within 24 hours.  2/10/22: Pt with a renal transplant developed NV, dehydration, tested positive for COVID, no hypoxemia, admitted for IV fluids and BP control.  He has improved, Nephrology consulted for renal function and medications, ortho consulted for foot pressure sores, no sign of active infection.  He was uncomfortable, wanted to go home, follow up with PCP, nephrology and wound clinic
during administration the syringe tip leaked vaccination.  The needle was fully penetrated into arm and dose leaked out from the base of the syringe tip/ base i.e. where the needle screws onto the syringe base.  Syringe was sealed and a single unit package with the tip and base already together but obviously it wasnt completly secured.  Pt did not receive full 0.5ml dose as a result.  No other incident/details to report
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:30 as dose 5 (booster), single (Lot number: 97 07) at the age of 65 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was no. Patient had known allergies: Yes
zoster related vision loss; zoster related vision loss; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a pt of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in 2011, the pt was vaccinated by a health care provider with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (lot# and route unknown). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: vision loss (blindness) and herpes zoster, requiring hospitalization. The outcome of blindness and herpes zoster was reported as ongoing. The causality assessment between blindness and herpes zoster with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, blindness was determined to be a medically significant event.
Patient bled initially, then immediately after removing the inject-safe bandage to replace with clean/dry bandage, the patient's arm puffed up right at injection site. Probably 1.5-2inches in diameter, obvious swelling and bruising under the skin. Reached out to patient 5 hours after administration, she said swelling has mostly gone down but there is a semi-hard bump where injection took place
beginning 7-9 hours after injection, lasting for 24 hours (until 31hrs after injection): fever (99-100 degrees F), chills, headache, muscle aches in legs (quads, hamstrings)
Fever, chills, body aches, headache, dizziness, large swollen area at injection site on my arm - very hot to the touch, approximately 6 inches in diameter
A lot of pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of pain in arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A lot of pain in arm). At the time of the report, PAIN IN EXTREMITY (A lot of pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
1/15/2021,NEXT DAY AFTER SHOT, PAINFUL AT INJECTION , SITE, FLU LIKE SYMPTOMS, CHILLS, 101 FEVER, BODY ACHES...TOOK SEVERAL IBUPROFEN 800 MG FOR ACHES AND FEVER.  TOOK TWO TYLENOL 4-5 HRS LATER.  BEDREST FOR TWO DAYS.  FEEL FINE NOW.
Patient's wife reported that a few hours after receiving the vaccination the patient began to experience hallucinations and delirium that lasted for many hours.  Patient was not oriented to Time and Place. Patient woke up this morning feeling okay again
Blood clot in left arm.  Woke up with arm pain in the same arm the shot was given 3 days after the shot. The pain was on the underside of my arm. Went to the drs and had an ultrasound done and a blood clot was found. They started me on blood thinners.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had six temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 256 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 288 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 552 hours, and 1.11 Celsius Degrees (34 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient vaccinated approximately 10am on 11/17.  Was fine that day.  Awoke 11/18 with significant rash on torso that spread within hours to involve most of body.  On re-examination in my office, had a very striking morbilliform rash, NOT urticarial, confluent into large blanching red patches on shoulders, scattered blanching red small fairly uniform papules on rest of body including palms, face, arms, legs, back, chest.
following injection i had increased pain in back and into legs. it increased to point of week of February 1 I was having difficulty at work. on 2/5/2021 i started having fesiculations in both lower extremities at rate of 300-400 per minute. pain increased in lower back and thighs. These increased to point of inability to work related to inability to sit more than 15 seconds and need of walker to mobilize. I scheduled with back specialist and neurologist, ended up hospitalized on 2/18/2021 released on 2/21/21 with diagnosis of benign fesiculations meaning no testing identified cause. currently still unable to work.
right medial subconjunctival hemorrhage ~12 hours after both Moderna vaccines without any other possible illiciting event. pt reports the hemorrhage continued to come and go for two weeks after the first Moderna dose.
Chest pains on left side- Steady for 15 days Shoulder pains on left side - Steady for 15 days  Severe Chest Pain in the middle of the night 10 days after the second dose.
Employee stated she got severe muscle selling and body aches the day after and had to go to ED for visit. She stated she was bent over having trouble walking. No active sx day of vaccine noted during observation time at da of vaccination. All handouts for fact sheet and V-Safe give prior to vaccine and employee was observed for appropriate time frame after Vaccine. Employee doing fine after couple of days from start of reaction. Employee went to hospital ED.
rash; This is a spontaneous report from a contactable pharmacist. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 24-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter is a pharmacist who reported that she was unclear that someone had called previously. Following a brief hold she requested information regarding administration of the second vaccine dose to patient who experienced an adverse reaction to their first dose. Pharmacist reports that their patient 24 yr male received his first vaccine dose and 24 hours later developed a rash. Pharmacist reports that the patient still has the rash and is now due for his second dose. Pharmacist ask can they give it or not. Pharmacist had a side effect after the first dose of the vaccine. Should patient get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had arm pain after moderna (couldn't move it fully); Had arm pain after moderna (couldn't move it fully); This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER  COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER  COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)). At the time of the report, MOBILITY DECREASED (Had arm pain after moderna (couldn't move it fully)) and PAIN IN EXTREMITY (Had arm pain after moderna (couldn't move it fully)) had resolved.            No concomitant medication information was provided. Patient received two boosters.  Patient stated that there was no issues after vaccination. Patient thought that his/her body was used to the jabs now and stated that patient would rather had side effects than Covid. Patient also travelled regularly union and 3 jabs were often required. No treatment medication were provided.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M019707, expiry date 25-OCT-2017, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse, for the GARDASIL vaccine a Pregnancy Registry concerning a 17 year old female with sulfa allergy and no pertinent medical history who on 29-AUG-2008 was vaccinated with the first 0.5 mL IM dose of GARDASIL vaccine (lot # not reported). On 29-OCT-2008 received her second 0.5 mL IM dose of GARDASIL vaccine (lot# 660393/0067X) and on 30-MAR-2009 received her third GARDASIL vaccine (lot # 661531/1311X). Concomitant therapy included antibiotics (unspecified) and CLARITIN. The nurse learned that the patient was pregnant from the report that was sent by an emergency department which the patient went in due to her pelvic pain. The nurse didn't know anything about the detail of the patient's pelvic pain. LMP was not specified. The patient sought unspecified medical attention. Additional information has been requested.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted shortly after recieving the first dose of the Pfizer COVID19 vaccine. Her brother was able to catch her before she hit the floor and regained consciousness 10 seconds after fainting. She felt flushed, sweaty and dizzy. She was seen by EMTs who arrived on site and pronounced her fine. Patient refused to go to the hospital to get checked out. Patient remained in the pharmacy until she was able to successfully walk around the store anf felt fine before leaving.
ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adversely affected by the Janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210960302.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In between 01-JUN-2017 and 31-JUL-2017, the patient was vaccinated with improperly doses of ROTATEQ, from lot # M045545, expiry date:10-JUN-2018, orally (dose unknown), and GARDASIL 9 from lot # M044717, expiry date: 19-JUL-2019 and lot # M036059, expiry date: 03-JUN-2019 (dose, dose #, route were unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccines were exposed to a temperature of -2 degree Celsius for 10 hours. Data logger was involved. There were no previous temperature excursions. No product quality complaint was involved.
On 5/11/00, the pt was vaccinated with Engerix-B. "A few days later", she experienced severe joint pain which was treated with paracetamol and Vicodin, prednisone and acetaminophen plus codeine. Approximately 4 weeks later, 6/7/00, the pt went to an ER. The pt reported she was dx'd with drug induced hepatitis and was hospitalized until 6/9/00. The most recent information received on 6/21/00, reported the joint pain in ongoing, and she stated she can not work or perform the activities of daily living. The pt reported "Vicodin, prednisone and Tylenol with codeine were the cause of the hepatitis". Additional information has been requested.
Information has been received from a nurse concerning a 70 year old male with no allergies and hypertension, reflux, high cholesterol and benign prostatic hyperplasia who "last week", approximately on 13-JUL-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The nurse reported that the patient was given ZOSTAVAX (Merck) and 17-JUL-2010 "three days ago", the patient experienced shingles. The patient was being treated with FAMVIR. at the time of the report, the patient had not recovered from shingles. The patient sought medical attention by an office visit. Follow up information was received from other health professional concerning the retired male patient who on 13-JUL-2010 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (Lot# unknown). On 17-JUL-2010, the patient experienced rash, pain, vesicular rash in the left side of chest anterior and smaller amount posterior and axilla. The patient's maximum temperature was 97.8 degrees and the level of pain was reported as 2 out of 10. At the time of the report, the patient was still symptomatic. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild type (WT) VZV strain or with the Merck vaccine strain. Additional information is not expected.
This was the Johnson and Johnson one shot. My mother received it and today is in the hospital with acculsive blockage in left brain, paralyzed from stroke and is being operated on.  I believe it is a blockage from the vaccine. She was old but extremely cognizant, independent, healthy, strong of sound mind.  This is why I am reporting it. If she dies I will report again.
Fully vaccinated with three doses of covid vaccine. Tested positive for COVID 19 on 01/29/2022.  Admitted to hospital on 02/08/2022. Expired on 02/09/2022 while still hospitalized.