chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received Moderna vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 11:06 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2022 at 11:06 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
syringe was visibly bent after administration and vaccination fluid ran down arm; syringe was visibly bent after administration and vaccination fluid ran down arm; Exposure via skin; A spontaneous report was received from a pharmacist concerning female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and she stated that the syringe was visibly bent after administration and vaccination fluid ran down arm.  No relevant medical history was provided. Concomitant medications were not listed.  On 11 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection.  On 11 Feb 2021,the reporter stated that the syringe was visibly bent after administration and vaccination fluid ran down arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event syringe was visibly bent after administration and vaccination fluid ran down arm was resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issues and exposure via skin for mRNA-1273 (batch: unknown) with no associated AEs.
PEDIATRIC 16 YEAR OLD PATIENT RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pediatric 16 year old subject received vaccine, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the pediatric 16 year old patient received vaccine and off label use was not reported. This report was non-serious.
Fever up to 102 by 9pm (9 hrs after administration). 5/28/2017 morning had fever to 103.7 with nausea and vomiting x1.
Arm was hurting one hour after shot was given, pt developed hives and itching 6 hours later. Pt saw PCP next day at 4pm and received Decadron shot, prednisone and Atarax.
Swollen bump on arm near injection site  Patient received first dose of pfizer vaccine and when time for second dose three weeks later theres was still bump on arm near injection site  Patient reports possibly reaction from bandaid and  reported no pain and it doesnt bother her  but appearance look swollen and so second dose was not administered  Patient was told to see doctor to confirm safety of second dose
Janssen COVID-19 Vaccine EUA  100.5 fever for 6+ hours followed by fever of 99 for next 18 or so hours. Chills for 2-4 hours. Stomach cramping and nausea for 3 days. Very tired and had dissyness for first couple of day. Severe headache for 2 days followed by mild headache for 3 days. Arm soreness at injection site. Swelling and redness at injection site on day 2, swelling has expanded each day following.   Treated fever with dayquil,  or nitequil every 6 hours or so for 2 days. Took extra strength tylenol on days following when I was not taking the dayquil.  Took pepto bismol and imodium for stomach issues. Only took one dose of either per day, not together.
Chills, aching, lethargy, headache, nausea, loss of appetite, severe unrelenting, unproductive cough. Change of allergy medication, two inhalers, oral steroid prescription.  Cough improving, other symptoms have abated.
Patient went to an annual eye exam and was diagnosed with swelling of the optic nerves.  Patient was sent for an MRI to rule out the possibility of a tumor or multiple sclerosis.  Patient is 5 months pregnant.  12/08/09 Visit notes for DOS 11/10/09 Pt c/o eye swollen and "stressed out". Pt had swollen optic nerve. Pt denied spinal tap. Pt did not have brain tumor.
Soreness in muscle around injection site, chills, body aches (muscles and joints), significant fatigue
Patient stopped into the pharmacy 2/15/21 8am, and notified the pharmacist of her heart racing and extensive arrhythmias that developed the night of the 1st vaccine dose.  The symptoms lasted for a couple hours then subsided.  She stated that her previous COVID infection may have precipitated her current arrhythmia problems. No other symptoms since that night
This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of VAGTA (lot # L031196, expiry date 05-FEB-2017) dosage regiment and route unknown. Concomitant medications  were not reported. The vaccine was subjected to temperature excursions.  The report is one of the several reports received from the same reporter. Additional information has been requested.
PT WAS ASKED IF SHE  WAS OK AFTER 20 MIN MOTHER AND PT STATED SHE WAS FINE. PT WALKED OUT WHILE THEY WERE FRONT OFFICE SCHEDULING NEXT FOLLOW UP APPT. PT FAINTED FELL AND HIT HER HEAD ON THE COUNTER ON HER WAY DOWN.
None stated. 9/15/09 PCP Medical records received DOS 8/12/09 to 9/8/09. Assessment: Muscle pain/Myalgia. Patient c/o decreased movement left arm. Point tenderness left shoulder, reduced shoulder flexion, reduced shoulder external rotation. Fine after ibuprofen. Rash on back, chest, breast, axilla. Rash red, raised, itching.
This is a 62y.o. male with a past medical history of liver transplant (2007) 2/2 alpha-1 antitrypsin, ESRD on HD TTSa 2/2 FSGS from transplant anti-rejection drugs, legally blind?, A flutter on eliquis, DVT on eliquis who presented from dialysis for hypotension. He reports some lightheadedness with his head turning. He also reports some nausea and diarrhea for the last few days. He denies any dyspnea, chest pain, palpitations, abdominal pain. He was recently admitted to Hospital for presumably his COVID infection.    Further chart review-  Patient previously hospitalized at Hospital and was noted to have Bacteroides fragilis bacteremia that was susceptible to meropenem, clindamycin, Unasyn, and metronidazole.    ED Course:  Vitals on arrival: 85/49, HR: 78, RR: 18, SPO2 0.88% on room air. Patient was placed on 5 L nasal cannula with increased to 96%. Blood pressure has remained low with MAP 56-66. He was given 500 mL normal saline bolus x2 and additional 250 mL bolus  with minimal improvement in blood pressure to 88/59, MAP: 69.  CBC remarkable for 3 BC: 15.7, hemoglobin: 11.8, baseline 11 , platelet: 457. BMP remarkable for sodium: 139, potassium: 5.2, chloride: 97, CO2: 14 with ATG: 23, BUN: 118, creatinine: 12.61. VBG: 7.33/32/16. Beta hydroxybutyrate: 0.24 hepatic function panel remarkable for alkaline phosphatase: 127. Lipase: 104, alkaline phosphatase: 6.5 troponin: 0.07, 0.07, 0.07. Blood cultures were obtained. Imaging: EKG: first degree AV block, CXR: consolidative process in LLL Medications: Cefepime, vancomycin started
Vomiting, headache, chills, body aches, fatigue, redness around injection site, sore arm. All lasted about 12 hours, except red arm. Still large red circle.
Closed passage to lungs-soreness and swelling in throat.  Gave Chloratrimeton. Wheezing, used inhaler. Pt used at home, took Chlortrimeton at home (with relief), reported to clinic. Told to call 911 if increased difficulty breathing. Talked with urgent care doctor at 14:00 at home today.
Wheeze, stridor, cough and shortness of breath.  8/3/09 ER records received DOS  6/23/09 Assessment: Allergic reaction, vaccine adverse reaction, stridor. Patient presents with cough, wheezing, stridorous noises. Difficulty breathing. Sore throat and chest pain. Minimal subglottic edema. Mild inspiratory stridor. Initially complains of blurry vision, nausea, sore arms, headache.
oPronounced swelling, redness, heat or hardness at the site of the injection; oExtreme sleepiness  oTwitching or jerking of the arm & leg. oVery Irritable
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 15:15 as dose 4 (booster), single (Lot number: 033K21214), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulphate" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: asa, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Antigenic test slightly positive the days ago; (unspecified date) Unknown result, notes: Treatment of COVID-19; (19Jul2022) Positive, notes: today very positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment with Paxlovid, treatment start date: 08Jul2022, treatment stop date: 12Jul2022,; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure, covid-19..
Sinus infection; Cough; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and COUGH (Cough) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced SINUSITIS (Sinus infection) and COUGH (Cough). At the time of the report, SINUSITIS (Sinus infection) and COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, COVID-19: positive (Inconclusive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Unable to lift injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift injection arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift injection arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received contains Event outcome was updated to resolved.
p/ recv vax on 4/8/98 pt devel abd cramps & diarrhea. following day pt exp urticarial hives on her legs & itchy lesions. 4/10 hives spread to arms/face. no react @ inject site. given oral meds 4/12
Paralysed; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysed) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 PARALYSIS (Paralysed) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralysed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment drug was provided by reporter.  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. A 19-year-old female patient, with no reported medical history, experienced medically significant event of paralysis from waist down after second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding first dose, clinical course, diagnostic tests or treatment performed 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. A 19-year-old female patient, with no reported medical history, experienced medically significant event of paralysis from waist down after second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event was not provided; hence latency cannot be assessed. No further details regarding first dose, clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
He states 1 hour after vaccination he had intense pain to upper teeth then pain moved to lower teeth/jaw and resolved by itself 3 days after.  He took Vicodin for pain.
Low grade fever (100 degrees) for 3 days. Aches in hips and knees. Chills and malaise. Local reaction at injection site resulting in difficulty of lifting right arm.
Patient made 2 appointments online, but they were only 2 weeks apart.  We did not catch that it was too soon.
1 1/2 x 1 1/2in erythema, warm to touch @ inject site; lt deltoid muscle ran sl temp, tx APAP;
The patient's arm swelled up significantly at the site of the injection, was warm to the touch, caused pain in the arm that she received the injection.
Pt. got PREVNAR 13 on 3/7/18. Delayed redness/soreness appeared staring 3/16/18 around injection site. Pt. improved w/BENADRYL and ibuprofen. Symptoms improved over 5 days and pt. recovered.
Normal side effects including very bad headache, fever 101.7 for 24 hours, chills, body aches, fatigue. After resolution of normal side effects strange mouth issues started. Severe Mouth burning, changes in taste, mouth lesions, sore throat. Still continuing day 5 post vaccine
DID NOT FELT HUNGRY WHICH WAS DESCRIBED AS LOW  APPETITE; CHRONIC JOINT PAIN; TIREDNESS/LETHARGY; NAUSEA, INCONSISTENT; PAIN AT INJECTION SITE; ACHINESS IN GUT; CONSTIPATION; DELAY IN MENSTRUATION; PREMENSTRUAL SYNDROME; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic fatigue syndrome, chronic joint pain, post-traumatic stress disorder, wonky metabolism, and  lyme disease and other pre-existing medical conditions included patient Had a fever 2 nights before shot but had a fever for 1 day. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at Left  Deltoid . No concomitant medications were reported. On MAR-2021, the subject experienced achiness in gut. On MAR-2021, the subject experienced constipation. On MAR-2021, the subject experienced delay in menstruation. On MAR-2021, the subject experienced premenstrual syndrome. On 20-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced nausea, inconsistent. On 24-MAR-2021, the subject experienced tiredness/lethargy. On 24-MAR-2021, the subject experienced chronic joint pain. On 26-MAR-2021, the subject experienced did not felt hungry which was described as low appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on MAR-2021, was recovering from nausea, inconsistent, had not recovered from tiredness/lethargy, did not felt hungry which was described as low appetite, chronic joint pain, achiness in gut, and constipation, and the outcome of delay in menstruation and premenstrual syndrome was not reported. This report was non-serious.
Hives; Itching at the injection site; Red at injection site; Itching and swelling at the injection site; Hardness at injection site; Itchy; "COVID arm"; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), URTICARIA (Hives), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Itching and swelling at the injection site). On an unknown date, the patient experienced URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Apr-2021 to 12-Apr-2021 for Adverse event, at a dose of 1 dosage form. On 12-Apr-2021, VACCINATION SITE SWELLING (Itching and swelling at the injection site) had resolved. On 14-Apr-2021, VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 17-Apr-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Treatment for the event included anti-itch cream.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics were updated.Concomitant products includeLisinopril/ttz,Rosuvastatin were added.Events Urticaria,Itching at injection site,swelling at injection site,Red at injection site were added
I received the covid-19 vaccine and tested positive for Covid-19 by PCR test; I received the covid-19 vaccine and tested positive for Covid-19 by PCR test; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular on 09Feb2021 (Batch/Lot Number: EL3247) (at the age of 36-years-old) as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL3247) (at the age of 36-years-old) as dose 1, single both for COVID-19 immunization. Medical history included acid reflux and seasonal allergies. Concomitant medications included dexlansoprazole (DEXILANT); cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she received the covid-19 vaccine and tested positive for covid-19 by pcr test on 03Aug2021. The patient visited doctor or other healthcare professional office/clinic visit due to events. No treatment was received for the events. The patient underwent lab tests and procedures which included covid-19 by pcr test: positive on 03Aug2021. The outcome of event was recovering.