chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid 19 treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 14Feb2021 as dose 2, single (Lot number: EL9267), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 09Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma (mild; seasonal)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica for Known Allergy: Lyrica. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received anti viral product as COVID 19 treatment, brand=Pfizer, treatment start date=02Jul2022 and treatment stop date=06Jul2022.
Suspected Vaccination failure; now both of them have shingles.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were received as follows:  This case is reported via chat. The reporter clients parent's got the shingles caccine and at the time of reporting, both of them have shingles.  The reporter asked, should I worry about client getting it from them. The male patint was mentally handicapped and has seizure disorder. The reporter don't know, how long ago the patient got the vaccine. The reporter was not a group home provider and do not hold a medical license of any kind. The reporter wasnted to know if need to worry about him having been in contact with them. This case was linked with US2020AMR044954, reported by the same reporter.
RIGHT LEG RED, SWOLLEN, HOT TO TOUCH. AUGMENTIN ES 600MG WAS THE TREATMENT.
Very painful arm unbelievably pain and swelling in my arm pit.  Fever and joint pain everywere all night and into next day.  4 days later still suffering with arm and swelling in arm pit.  Arm pit feels like I have a infection .  Still very tied just want to sleep.  I will not be getting the second dose feel like I was not inform of these side effect well.  I had corvid in 10/20 I think the dose should be adjusted for someone who has already had it.  I will differing not be getting anymore of this.  Just hope I can get back to normal.
injection site reaction; Tendernes of the skin 2-3 inches from the injection site; Swelling of the skin 2-3 inches from the injection site; Redness on skin; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness on skin), VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) in a female patient of an unknown age 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 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site). In January 2021, the patient experienced ERYTHEMA (Redness on skin). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reaction). At the time of the report, ERYTHEMA (Redness on skin), VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) outcome was unknown.        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.   Concomitant medication included  birth control pills No treatment medication were provided.
reported by parents 5 days post vax requiring MD visit;rt deltoid area edematous,w/firmness in center beneath scabbed inj site w/surrounding area red,raised,warm,itchy,measuring 3x4 inches;center of area clearing w/o rash,sl discolor
Incidence of dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experinced dizziness. The reporter did not consent to follow-up.   Upon an internal check, the following corrections were performed: The concomitant was deleted was capture inadvertanly.
Red/Raised/Itching at injection sight starting the day after the injection for 3 days.  Then went away like nothing happened. Red area the size of small egg.  February 12 the red area is back same size, slighty raised.
ANKYLOSING SPONDYLITIS FLARE UP; Sore arm from Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Sore arm from Covid vaccine). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and VACCINATION SITE PAIN (Sore arm from Covid vaccine) outcome was unknown.            No concomitant medications were reported.  The daily dose of HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) was reported as Citrate free.  The daily dose of Moderna Covid-19 Vaccine was reported as 1 in 1 once.  The reporter's causality for the events of ankylosing spondylitis flare up and sore arm from COVID Vaccine with HUMIRA (ADALIMUMAB)was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning a female patient born in 1964 with medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis, vaccinated with Moderna COVID-19 Vaccine on May, June and December 2021 who experienced the unexpected  event of ANKYLOSING SPONDYLITIS (seriousness criterion medically significant) and other expected event unknown days of 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a female patient born in 1964 with medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis, vaccinated with Moderna COVID-19 Vaccine on May, June and December 2021 who experienced the unexpected  event of ANKYLOSING SPONDYLITIS (seriousness criterion medically significant) and other expected event unknown days of 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
FELT LIKE RUN OVER BY TRUCK; UNSTEADY; COMPLETELY LOST HEARING IN LEFT EAR; VERTIGO/SPINS; FELT SICK; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. The patient's past medical history included: low vitamin D, and concurrent conditions included: hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A and expiry: 19-SEP-2021) dose was not reported, 1 total administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient had completely lost hearing in left ear (hearing issue began in beginning of September), Woke up and couldn't hear well and had vertigo and had spins, unsteady (gave medicine for vertigo and spinning). Hearing is still gone. The hearing loss happened all of a sudden, woke up one day and hearing was gone. On 08-APR-2021, the patient experienced felt sick, low grade fever. On an unspecified date, the patient experienced felt like run over by truck. Laboratory data (dates unspecified) included: Vitamin D low. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo/spins, unsteady, felt sick and low grade fever on 11-APR-2021, had not recovered from completely lost hearing in left ear and the outcome of felt like run over by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114640-COVID-19 VACCINE AD26.COV2.S- completely lost hearing in left ear. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
nausea; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient 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. The patient's relevant medical history included: "lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs"; Bnt162b2 (Dose 2, single), for COVID-19 immunization, reaction(s): "Chills", "nausea", "Fever"; Bnt162b5;bnt162b5 omi ba.4-5 (Dose 3, single), for COVID-19 immunization, reaction(s): "Chills", "nausea", "Fever". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Patient, almost 72 years of age, has had 5 previous shots of the Pfizer COVID vaccines. She was calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The subsequent doses it was always the nausea and the chills and things like that, fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300612 Same reporter, patient, product, events different dose;US-PFIZER INC-202300300609 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300299983 same patient/vaccine, different vaccine dose/event;
Pain at the injection site; Redness / at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose in the left arm. The patient experienced redness and pain at the injection site. Both had resolved after a few days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029290:Same reporter
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PROQUAD (lot # M009745 with expiration date 23-AUG-2017, lot # M014302 with expiration date 22-SEP-2017, lot # reported as M012053 with expiration date 11-JUL-2017, lot # M004894 with expiration date 26-JUL-2017, subcutaneous, dose not reported. No adverse effects were reported. The patients would continue vaccination with PROQUAD. This is one of two reports received from the same source. Additional information has been requested.
After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto floor and +hit back of her head.  She does report history of syncope after injections. BP 96/58, P48, R17, O2=98%. Alert and oriented. No deformity.  Moving all extremities. Denies headache, nausea. She was on stretcher and after 15 minutes felt better.
Entire arm sore. Slept before and after dinner. Slept on and off for 4 more days. Was weak and tired. Next yr. take lo dose instead.
Burning eyes; hurting my quality of life; Itching eyes; Meibomian gland is swollen; Feels like I have sand in my eyes; Diagnosed with Dry eye on February 2022; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life) and EYE PRURITUS (Itching eyes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eye (Mild case of dry eye such as Itchiness before the pandemic, became worse during pandemic) and Attention deficit hyperactivity disorder (+). Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Attention deficit hyperactivity disorder.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced DRY EYE (Diagnosed with Dry eye on February 2022). On an unknown date, the patient experienced OCULAR DISCOMFORT (Feels like I have sand in my eyes), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen). The patient was treated with LIFITEGRAST (XIIDRA) at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: Had no allergies, but reacted much later. On an unknown date, SARS-CoV-2 test: (Negative) Always tested Negative for COVID-19.         Patient's height was reported as 5'2  Patient was asking if she could take 2nd Booster dose. Patient had mild case of dry eye such as itchiness before the pandemic, but symptoms became worse during the pandemic. Patient was not sure if the event was related to Moderna vaccine.  Patient seek medical care from Opthalmologist. It was reported that the symptoms got worse.
pt exp wheezing & eye swelling w/in 1/2hr of vax;failed to respond to resp rx,also vomited,exp inc diff breathing & retractions;cont to wheeze,adm to hosp for rx;devel productive cough & sinusitis;
Pt received MMR today. Within  1/2 hour, post began feeling faint, w/ itchy sensation.  Has hx history w/eggs in past but no hx itching or respiratory symptoms. Pt has been ill w/cough & diarhea, last four days.
knee pain, beginning in same side leg and then to both; fever 100.2F, non-weight bearing from 4 hours after immunizations to present; irritable; screaming/crying; low energy; decreased appetite
This spontaneous report was received from a medical assistant and refers to an unknown number of patients (age and gender were not reported). Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with an unspecified doses of improperly stored RECOMBIVAX HB (lot number, expiration date, dose, strength, route of administration and frequency were not reported). Concomitant medication was not reported. No adverse effects were reported. This is one of three reports form the same reporter. Additional information has been requested.
One week following the first dose developed hot (101.4 temp as taken by a contactless thermometer), swollen, itchy, raised, painful rash around injection site. Entire arm was tender and achy and irritated site extended 8x6 inches to cover most of the upper arm. The symptoms worsened for 2 days before beginning to subside, with the rash fully gone by the morning of 4/24/21.
This spontaneous report as received from an office manager, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 27-SEP-2017, the patient was vaccinated with a dose of PROQUAD lot # M007965 expiration date 15-AUG-2017 (dose and route were not provided) for prophylaxis. No adverse effects were reported. This was one of two reports received from the same source. Sender's Comments: US-009507513-1710USA012261.
Loss of taste 2 days post vaccination Severe arm pain at injection site, tingling at injection site, burning at injection site for 2 days post vaccination. Headache Lethargy Muscle Aches Extreme tiredness Light rash on stomach Itching inside eyes
Itching, reddness 6cmx8cm. Slight fever to right deltoid. Referred to private physician for evaluation. Benadryl for itching, warm cloth for circulation and comfort.
Patient reported that their arm and hand had become swollen and painful and had lack of movement.  Patient was informed that they should seek further medical attention.
Dizzy; Episode of vertigo; This is a spontaneous report from a non-contactable pharmacist. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 21Apr2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient was dizzy and experienced episode of vertigo that lasted 20 minutes. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event dizzy and episode of vertigo was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Vaccinee (case #7) rec'd 1st dose (rt deltoid) of Engerix-B on 18APR90 (3rd dose in series of Hepatitis B vax); Testing for titers on 24MAY90 indicated did not seroconvert;
My left arm was sore after the injection exp red patch, hot to touch for 24 hrs. The level of pain in my left arm kept me up at night.
Pt recvd vax t104.3 & brief restless sleep patterns-difficult to console when awake past 24hrs; took fluids not solids; Seen @ ER dx by culture w/strep throat;
Chills, body aches, headache Lasted 7 hours  Fine the next day
Approximately 20 minutes after receiving the 2nd covid vaccine pt reported feeling lightheaded and dizzy which progressed to flushed blotchy redness on chest and neck.  BP 190/104. Approx 3 minutes later pt reported feeling like throat was swelling and was having difficulty swallowing. Pt had premedicated with Benadryl 25mg po prior to arrival due to history on anaphylaxis to multiple other medications and foods. Benadryl 25mg po was administered and pt assisted to exam room. Pt began to be anxious and said swelling was getting worse. Epinephrine (1mg/ml) 0.5mg IM administered per standing order.Refused ambulance or transfer to ER at this time. Husband at side and said this has happened previously and she knows how to manage without the ER.  10 minutes after 1st dose of epinephrine a second dose of 0.5mg epinephrine administered due to continued swelling. PT was monitored in clinic. Left ambulatory with no resp distress or resp symptoms noted. Pt and husband refused EMS and ER. Instructed to follow-up with PCP and s/s to seek further treatment from ER.
Blood Cloots in legs and lungs.   Sweeling legs, couldn't breathe. Hospital and drugs.  Still continiting treatment.