chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's pertinent concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. On 25-MAR-2016, the patient was vaccinated with the first dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). On 27-MAY-2016, the patient was vaccinated with the second dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). On 08-AUG-2016, the patient was vaccinated with the third dose od ROTATEQ, administered orally (strength, lot number and expiration date were not reported) and on 28-OCT-2016, the patient was vaccinated with an extra dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). Additionally, no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
pain in his lungs / lungs are heading; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY PAIN (pain in his lungs / lungs are heading) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (pain in his lungs / lungs are heading). At the time of the report, PULMONARY PAIN (pain in his lungs / lungs are heading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Woke up day after with soreness around the site. Later in the evening presented with hives just under the vaccination site. Ice was applied but still sore, inflamed and hot to the touch. Patient took Benadryl. No other symptoms presented.
Rheumatoid arthritis flare up; Injection site burning; This is a Spontaneous report based on the information received by Pfizer. (MFR Control No. # 21K-163-4120930-00).   A 56-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), intramuscular on 10Mar2021 (At the age of 56 years) as DOSE 1, SINGLE, patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) intramuscular on 31Mar2021 (At the age of 56 years old) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from Jun2020 (Batch/Lot number was not reported) to May2021, at 40 mg,1 in 1 wk, subcutaneous from 03Oct2021 (Batch/Lot number was not reported) and ongoing, at 40 mg,1 in 1 wk for rheumatoid arthritis; etanercept (ENBREL), via an unspecified route of administration from 02May2021 (Batch/Lot number was not reported) to an unspecified date, at UNK, single for an unspecified indication. Medical history included Formaldehyde allergy manifested by inflammation, Nickel/Cobalt allergy manifested by rash from an unknown date and unknown if ongoing, alcohol use from 1983 to an unknown date, one drink a week of margarita or wine and was a non smoker. Concomitant medications included methotrexate and folic acid were taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine sodium taken for hypothyroidism, start and stop date were not reported. The patient experienced rheumatoid arthritis flare up and vaccination site burning on Mar2021. Patient also had device issue and it was difficult to use on 10Oct2021. At the time of reporting the outcome of the event was recovered for rheumatoid arthritis and was unknown for vaccination site burning.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician via a company representative referring to an article. The company representative could not confirm whether any patient was mentioned in the article. Therefore medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient or patients were vaccinated with a dose of an unidentified Merck HPV vaccine (trade name and lot number were not provided). On an unknown date, the patient or patients, experienced ovarian failure, amenorrhoea and premature menopause. The outcome of ovarian failure, amenorrhoea and premature menopause was unknown. No product quality complaint (PQC) was involved. The relationship between ovarian failure, amenorrhea, premature menopause and therapy with the unidentified Merck HPV vaccine administered was unknown at the time of the report. Upon internal review ovarian failure was considered serious as medically significant. Additional information is not expected because the reporter refused to be contacted.
Subcutaneous PNEUMOVAX given on (R) posterolateral upper arm yesterday 8/26/11 & pt r/t today w/ approximately 22 x 10cm area red, hot, indurated, tender area at/around injection site. Referral to Urgent care for eval of cellulitis vs extensive localized rx w/ advice: ibuprofen, cool compresses & hydrocortisone cream as well.
The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.
About 10 days after vaccination, developed fever, sore throat, and classic URI symptoms with fluid in ears
Pregnant patient miscarried at 17.5 weeks gestation with an otherwise uncomplicated pregnancy and no other current illnesses or conditions.
The patient's mother called on 10/24/2001 to state that the patient had an allergic reaction to vaccines given 10/15/2001. She developed a rash of pimples at the injection site and her Mom took her to the family Dr who started this was an allergic reaction.
PT ADMINISTERED 1ST DOSE OF COVID PFIZER VACCINE. WAS TOLD TO SIT FOR 15 MINUTES. AFTER ABOUT 5 MINUTES, WIFE NOTIFIED PHARMACY STAFF OF PT PASSED OUT IN CHAIR (SLUMPED OVER). AFTER PHARMACIST ATTEMPTED TO GET ATTENTION, HE REGAINED CONSCIOUS BUT WAS CLAMMY AND SWEATY. PT ASKED FOR A GLASS OF WATER.  AFTER A FEW MINUTES, HE STATED HIS CHEST WAS HEAVY AND VISION BLURRY.  1 DOSE OF AN ADULT EPIPEN WAS ADMINISTERED WITH PT CONSENT. HE STATED HE FELT BETTER. WIFE REQUESTED EMS BE CONTACTED.  EMS DISPATCHED AND PT LEFT PHARMACY CONSCIOUS IN A STRETCHER.
developed frozen shoulder after the flu shot; Initial information was received on 12-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211117000538).  This case involves an adult patient with an unknown gender who developed a frozen shoulder (periarthritis) after receiving INFLUENZA VACCINE.   The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious frozen shoulder after the flu shot (periarthritis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
COVID FOR ONE WEEK AND HAD MILD SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS). At the time of the report, COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. An elderly female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. Event lasted one week and she had mild symptoms. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. An elderly female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. Event lasted one week and she had mild symptoms. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; MILD LETHARGY; This spontaneous report received from a patient concerned a 66 year old male. Initial information was processed along with the additional information received on 24-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, patient experienced mild symptoms such as headache, loss of taste (lasted longer) (suspected covid-19 infection), also experienced lethargy. On an unspecified date in APR-2021 (few days after Easter Sunday), the patient was tested positive for coronavirus disease (COVID-19) (suspected clinical vaccine failure). Patient was unsure which test was used for positive result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and mild lethargy, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846583. This report was associated with product quality complaint: 90000190822.; Sender's Comments: V0: 20210846926-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Painful arm times 5 days, sleepless night-awakened, low grade fever.
Vertigo requiring prednisone  then  ear drops. Had to not work / do anything for 2 weeks then work remotely did 2 more weeks
Patient contracted COVID four months after receiving PFE/BNT vaccine; Patient contracted COVID four months after receiving PFE/BNT vaccine; This is a spontaneous report from a contactable consumer via agency. An adult male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Dec2020 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient had not been diagnosed with COVID-19. It was reported the patient contracted COVID four months after receiving BNT162B2. It was reported the patient tested positive for COVID post-vaccination. It was unknown if treatment was received. The clinical outcomes of the events were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Chemical in covid vaccine caused reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after administration of vaccine Chemical in covid vaccine caused reaction. The outcome of the event was unknown.   Information about batch/lot number has been requested
Hyperthyroidism symptoms (racing heart rate, hot flashes) and months later developed actual hyperthyroidism confirmed in blood test
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of VARIVAX (Merck) 0.5 ml injected subcutaneously (strength, dose, lot# and expiry date unspecified), post both supported and not supported temperature excursions. No concomitant medications were reported. No adverse effects were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
SLE flare (severe recurrent arthritis); SLE flare (severe recurrent arthritis); This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Evaluation of immune response and disease status in Systemic Lupus Erythematosus patients following SARSCoV-2 vaccination. Arthritis Rheumatol;74(2):284     Concurrent medical conditions included Systemic lupus erythematosus.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) (seriousness criterion medically significant) and ARTHRITIS (SLE flare (severe recurrent arthritis)). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) and ARTHRITIS (SLE flare (severe recurrent arthritis)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) and ARTHRITIS (SLE flare (severe recurrent arthritis)) to be related.    Concomitant and treatment were not reported.  Company comment: This literature non-study case with limited information on patient with medical history of Systemic lupus erythematosus, experienced the unexpected serious AESI event Systemic lupus erythematosus on an unknown data after second dose of mRNA-1273 which taken on an unknown date. It was reported that the patient had an SLE flare and recurrent arthritis. At the time of reporting the outcome was unknown. The patient's medical history of Systemic lupus erythematosus remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2022-475935 (Patient Link).; Sender's Comments: This literature non-study case with limited information on patient with medical history of Systemic lupus erythematosus, experienced the unexpected serious AESI event Systemic lupus erythematosus on an unknown data after second dose of mRNA-1273 which taken on an unknown date. It was reported that the patient had an SLE flare and recurrent arthritis. At the time of reporting the outcome was unknown. The patient's medical history of Systemic lupus erythematosus remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
Cough leading to left sided chest wall pain; Persistent sign of sinus respiratory tract infection; Systemic sclerosis with immunosuppressant drug therapy.
The site was red the first couple of days then went away. Arm was a little sore like normal from getting any other injection.  Yesterday evening the site was itching and then today it is bright red at the injection site and the size of the red spot is about 2 to 3 inches big.  It is warm to the touch.
p/vax pt had onset malaise, diarrhea, nausea progressing to vomiting, dizziness & syncopal by 630PM suspect coincidental illness;
Patient threw up 10mins after vaccination, twice, EMS was called. They advised to take her to hospital, she refused against medical advice
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/19/2021 with Pfizer EW0162 IM in left deltoid.
Patient recieved covid 19 vaccine 6m-4y that was diluted with 2.2ml instead of 1.1 ml
Pt received DTap #4, IPV #1, HiB #4 with Hep B #1 and Varicella. In about 5 minutes pt mom called attention to rash on pt back, pt fussy/crying, rash also appeared on cheeks. MD assessed pt and ordered Epinephrine 1:1000 0.1ml SC given (pt had no stridor, no wheezing). Improved within 5 minutes.
Case number PHHY2014US066985 is an initial literature report received on 29 May 2014. The authors discussed about a rare case of ADEM (acute disseminated encephalomyelitis) after seasonal flu vaccination and its radiographic response to plasma exchange. This report refers to an 83-year-old female patient. Her medical history included hypertension, stroke and diabetes mellitus. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown. One day after vaccination, she experienced increasing somnolence, lower extremity paresthesia and generalized weakness. She also had fever (103.5), tachycardia. and tachypnea. She was not following commands, withdrew only to pain and had diffuse hyperreflexia. CT (computerized tomography) of her head was normal. Her condition deteriorated requiring emergent intubation. MRI showed diffuse abnormal FLAIR signal in the periventricular white matter, splenium of the corpus callosum, sub cortical structures and brainstem. She had an elevated creatinine of 1.5, AST (aspartate aminotransferase) of 98 and ALT (alanine aminotransferase) of 89. CSF (cerebro spinal fluid) showed 33 WBCs, 3 RBCs, protein 136 and glucose 108. She was treated with empiric antibiotics and antivirals. When all cultures were negative, she received five days of high dose steroids for post-vaccination ADEM. There was no clinical response and an MRI brain showed worsening FLAIR changes. She was subsequently treated with plasma exchange (PE) and a repeat MRI brain showed significant radiographic improvement. The author concluded that influenza vaccination has been rarely linked to ADEM. Due to a low-incidence of the disease, there are no established treatment guidelines. Our patient did not respond to steroids but showed marked radiographic improvement with PE. PE should be considered for refractory ADEM after influenza vaccination.
pt exp local react @ site RLE-pain, swelling, inc warmth, induration/lump w/o abscess; fever 38.0; rash; allerg react; anaphylaxis;
Right deltoid region red, warm, tender and grossly swollen. Affected area approx 4 cm x 5 cm. Otherwise fine. Seen 4/15/03 by an MD.
Sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 19:45 (Lot number: Fk5127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Nov2021 20:00, outcome "recovering", described as "Sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient has not been tested for Covid-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
To the best of my knowledge I contracted this virus through someone laying on my bunk and having their shot area exposed and then I laid on that same spot.
no adverse event; Administered vaccine after temperature excursion; This spontaneous report was received from a consumer and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 24-JUN-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent the temperature excursion. Previous temperature excursion was detected.   On an unknown date in 2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe, 0.5 ml, lot number: S021740, expiration date: 25-MAR-2021, for prophylaxis (route of administration was not provided). The digital data logger was involved. No product quality complaint (PQC) was present.  This is one of several report from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA002507: US-009507513-2007USA002422:
My wife and I returned home from a trip to another country on 1/19 and felt fine. My wife got sick first, I noticed on the 22nd the lack of smell and I had cold symptoms throughout that week. On Monday I called the doctor and he prescribed PAXLOVID. I started taking it that evening, and took it for 5 days. On Sunday 1/29 my wife and I both tested negative at home. My symptoms at this point are pretty much gone, some congestion.