chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications. On 21-MAY-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with shingles and suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of his condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, he 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 the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. The outcome of shingles and hearing loss was not recovered. The reporter considered shingles and hearing loss to be related to zoster vaccine live (ZOSTAVAX).   The events were considered to be disabling. Upon internal review, the event of hearing loss was considered to be medically significant.
Patient got a rash on the arm that the injections were given. Started as a small red spot then began to spread to the entire upper arm. She states it itches and hurts. Arm was still red at time of this report.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number unspecified). The physician stated that the patient called the office and mentioned that she experienced muscle and joint tenderness sand soreness mostly in her hands and arms after having received the first dose of GARDASIL. The consumer stated that the symptoms did go away eventually; however, the consumer decided not to receive any more doses of GARDASIL. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. Follow up information has been received from a registered nurse concerning the 24 year old female housekeeper with no pre-existing allergies or other relevant medical history who on 18-AUG-2009, at 15:15, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 659182/1757U) into her left arm. On 18-AUG-2009 the patient developed muscle and joint tenderness in hands and arms. The patient stated that she could not move her fingers for a couple of days and her legs were really stiff. There was no illness at time of vaccination. There were no laboratory diagnostics studies performed. On an unspecified date, the patient recovered. Additional information is not expected.
once the patient left the pharmacy after receiving the flu shot (about 35 mins after the injection), patient was shopping and felt very light headed, dizzy and had a little bit of shortness of breath. She said she felt fine when she went home. She said she didn't feel the need to seek treatment. I told her I didn't feel comfortable giving her the flu shot again until she got her doctor's okay. This happened over a year ago and she has no current complaints.
4 days after immunization patient got 4-5 large red spots on body. Since that time the rash has spread over chest, arms, and back but the spots are smaller. The large spots were small blisters, but the smaller ones do not have blisters. Patient going to try BENADRYL, hydrocortisone cream and call the MD.
Arm soreness; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient received any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 18Apr2021 at 14:44, 10 days after the vaccination, the patient experienced arm soreness. No therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event arm soreness was recovered on 18Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right arm, R ear pain and dizziness, progressing facial numbness, possible focal seizures or syncope. No shortness of breath, difficulty swallowing or rash/hives. BP=129/92, HR=80.
wake up with headaches, developed polymialgia rheumatica, runny nose, breathing issues, shortness of breath and constant cough.  Weak, trouble waking, trouble sleeping, said rheumatica could last one to 8 years and you have to take steroids.  Trouble raising arms over head, dressing, pulling down pants.
Starting March 29, 2021 Intense Migraines causing dizziness resulting in nausea. No appetite. Very tired. Full body aches. Lasted for about 3 days. Welt formed on injection site on April 5, 2021, Rash formed on right lower leg April 5, 2021.  As of April 12, 2021 The welt is starting to disperse on the arm, but is very itchy and now there is a red ring around a white area where the welt was. The rash has gone away but left a couple scabs. Still having migraines every day.
Case number PHEH2013 US024509 is an initial spontaneous report from the consumer received on 19 NOV 2013. This report refers to a female patient of an unspecified age. The patient became pregnant on an unknown date and her last menstrual date was not provided. This pregnant patient received FLUVIRIN 2013/2014 (batch number: not reported) on an unknown date. No adverse event reported following the vaccination. No other information was available.     Follow up information received on 19 NOV 2013. Reporter was anonymous so this case is lost to follow up.
About a week after vaccination, injection site in left arm had hard lump with an area 5" in diameter that is red, swollen and hot.  Joint pain and malaise also present.  Treated with antibiotic and ice.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2011, the patient was vaccinated with ZOSTAVAX for permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient developed shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX (Vaccination failure), and suffered serious physical, emotional (emotional distress), and economic damages as a result of patient's injuries (Injury). On or about 09-NOV-2016, the patient was treated by a physician for shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain (Pain) and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
On 4/6/17 Mom called to say pt's left leg has been red, swollen and painful to touch at injection site. Pt also had fever. Appt with doctor scheduled for 4/7/17. Per visit notes, patient had left thigh swelling and erythema s/p vaccines (PROQUAD). Itchy. Initially painful but pain resolved. Had fever x 2 days. Tmax 102. Given motrin. Fever since resolved. No concerns for infxn. Walking fine. Advised cool compresses and avoid scratching.  Benadryl prn at bedtime if uncomfortable.  Claritin daily x 1 week. Observe for tenderness, spreading redness or swelling, or fever.
Immediate burning sensation upon administration of vaccine.   Red & swollen injection site.  Fever (101.3) and chills within 7 hours from time of administration.  This continued for 24 hours.  Fever blisters on upper lip.   Large swollen glands under arm the size of grapefruit on same (left) side of injection site noticed 48 hours.
Large Marble-Sized lump at Vaccine site on upper Left Arm.  Swelling and painful.  No discoloration.  Only hurts if pressed on, but even lightly touching site causes mild pain.  Gave patient 400 mg OTC ibuprofen for pain and swelling, I will apply ice to her arm as well.  I was just informed of the condition and have treated, but have not had time to see results of treatment.
Developed an itchy, pink rash on upper left arm at injection site.  It spread up and down arm away from injection site over the next several days.  Patient was prescribed prednisone by provider and it is resolving.
A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 24-month-old female patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous seasaon and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow up received 30-Apr-2009L added product complaint investigation results.
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 77-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Moderate high blood pressure" (unspecified if ongoing), notes: Moderate high blood pressure; "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Negative; (10Jul2022) Negative; (12Jul2022) Positive, notes: Positive again on 12Jul morning. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Other medication in 2weeks: No. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Jul2022, Treatment stop date: 07Jul2022. Adverse event: I start Paxlovid treatment on 03Jul and finished on 07Jul. Test negative on 08Jul and 10 but Positive again on 12Jul morning. If treatment ae: No. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Patient had a large red swollen area at injection site that was hard for 3-4 days, overall patient didn't feel well.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored M-M-R II. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was given Kinrix at 4 months of age. This is only licensed for 4 -6 year olds. Pt had no immediate reactions. Pt was called two days later and mother reports some small amount of irritation on the thigh and some irritability. Over all no significant adverse effects noted.
On 3/23/21.  Evening began with dull  ear ache left side.  Followed by pain left side base of head.  Pain increased daily.  In 3/26/21  facial paralysis. Became apparent.   Primary Doctor recommended ER.  ER  Diagnosed Bell?s  Palsy.
Per Client received first Pfizer COVID 19 vaccine on 2/23/2021 in left arm, slight redness and tenderness at site. Received second Pfizer COVID 19 vaccine on 3/24/2021 in left arm and old site became symptomatic not new site: Hot, red, swollen, painful, hard to touch two inches across site. Next day on 3/25/2021, chills, fever of 102, nausea, vomiting x 2, fatigue and sore left arm pit. Client reported taking Ibuprofen, applying cold and warm compresses to site and no follow up with PCP as of yet. Client reported still having symptoms and will plan to follow up with PCP if still having concerns on tomorrow. PHN encouraged Client to continue monitoring site and to follow up with PCP.
Post vax, this pt experienced sore throat for 3 weeks, fever of 103.8, nausea and vomiting 2 days post vax, weak and general malaise. Sought unspecified medical treatment.
Vaccine for virus vaccine.  Bottom of vial was cracked and no liquid in vial.  Noticed when attempted to withdraw diluent.
Woke up on 4/13 and got out of bed. Left upper left calf was painful when straightening my leg. Has not improved throughout the day. Feels tight and as if strained, but I have literally done nothing but walk or sit at my computer in the last week and cannot pinpoint an activity that would have strained a muscle.
Patient with a big, red, warm to touch bump on (R) deltoid, the day after vaccine was administered.
Given SQ Varicella in (R) forearm at 1440 on 1 Nov 13. Pt states when she got home, her "hair itched and she didn't feel well". Took 3 BENADRYL and went to bed. Arm swelled up "really huge" and had pain. Alternated heat and cold, and MOTRIN and TYLENOL all weekend. Came in today at 1400, and had 44 x 25 cm red, raised, firm area on (R) arm.
Muscle pain; Joint pain; Fatigue; Headache; Nausea; Chills; Vaccination site pain; A spontaneous report was received from a Consumer concerning a  73 Years-old female patient who received Moderna's   COVID-19 vaccine (mRNA-1273) and experienced events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:028L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, The patient experienced the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea.  Treatment details Tylenol was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, which events are being referenced here were unknown.  The reporter assessed the events vaccination site pain, fatigue, headache, muscle pain, joint pain, chills, nausea as related to study drug.
got super sick; high fever/body was on fire; chills; bad body aches; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient is pregnant. It was unknown if patient had other vaccine in four weeks, if she had covid prior vaccination and if covid tested post vaccination. The patient got super sick at about 1 am with a high fever/body was on fire, chills, bad body aches and headache. It was unknown if the patient received treatment. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I have hives on my face that itch and burn.  I have had them since 6/13 and I got my first shot on 6/8.  I have swelling in my face as well and dry rash around my eyes.
MOC reports that child had a fever up to 102 and a rash over her entire body.
Received PNEUMOVAX at 10 Am by 1 PM vert severe arm pain and even swelling. Some relief with ZYRTEC. Pain was severe, hardly slept that night - pain at site of PNEUMOVAX injection.
Pfizer when mixed diluent .9mL was used instead of the correct 1.8mL. Patient was still given 0.3mL Patient checked 3 days later no adverse reaction. Patient is doing fine.
Narrative: 88yo male patient who does not receive medical care here but did receive covid vaccine on 1/15/21 & 2/21/21 from here, did on 10/24/2021. No information given about pt's death. Pt's PROBLEM LIST: GERD - Gastro- Esophageal Reflux Disease Aortic valve stenosis Fall Hearing Loss Hypothyroidism Hyperlipidemia Restless legs Mild cognitive disorder Osteoporosis Malignant tumor of hypopharynx This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Pt states that shot really burned when given. That evening her arm became very sore and she could not even lift it. That lasted for 2 days. The next day she had temp of 102, bad headache, body aches and diarrhea.  The diarrhea lasted for 3 days. She saw her physician who advised her not to do any flu shots for a couple of years. States has had many flu vaccines but never had any problem.
Got the second dose and she was pregnant; Feeling tired; Headache; Chest pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 28May2021(Pregnant) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection) on an unknown date for covid-19 immunization. Reporter reported for the side effect of his wife (consumer). It was reported that, She got the second dose yesterday and she was pregnant, she felt well yesterday last night after she got the vaccine. On 29May2021, she was kind of feeling tired, had headache but she felt like chest pain. Also reported that If she needed to go to the hospital or wait because she was feeling better now. The outcome of the events headache, feeling tired and chest pain was reported as recovering and for got the second dose and she was pregnant was unknown.  Information on Lot/Batch number has been requested.
Periodic bouts of extreme fatigue typically mid day needing to sleep for an additional  4 hours after a good nights sleep.   Episodes occur every week or 2.  Never experienced this before Covid Vaccine.  Events have not diminished 5 months later.
Activation of dormant shingles. A course of Valacyclovir and Prednisone for seven days. Seems to be controlled.
Case number PHEH2015US009004 is an initial incomplete report from a nurse received on 07 May 2015 with a follow up spontaneous report from a nurse received on 18 Jun 2015. This report refers to a 62-year-old male patient. Medical history included ethyl alcohol (ETOH) abuse. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 14511P) on 24 Mar 2015 in his left deltoid which was outside of normal temperature range at 19.1 C for 68 hours. No further information was reported. Follow up report from a nurse received on 18 Jun 2015: Update patient demographics, medical history and data of vaccination.
Nausea, Vomiting, chills and fever, back, rib cage, headache, and diarrhea. Beginning 6/11/2015 through 6/15/2015 - Emergency Room Treatment on 6/11/2015 diagnosed above symptoms. Discharged.
p/vax pt exp nausea, feeling cold, internal tremors & had an elevated temp of 101.6;