chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored GARDASIL lot # L018466, expiry date: 16-JUN-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. Lot number# L018466 is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003211: US-009507513-1612USA003212: US-009507513-1612USA003210.
Aunt called about localized reaction to right upper arm (deltoid). Received DTaP on 3/17/04. Aunt instructed to do warm compress and Bendryl. If no results come to health department. Aunt came to HD- Right upper arm visibly swollen, warm to touch, red and tender. Swollen area entire size of right deltoid. Bendyl helped lessen swelling, but pt referred to clinic to be evaluated by MD. Appt made by nurse for today at 11:00 AM
Started getting slight tingling in face and very slight ringing in ears.  It lessened through the night and gone by next day around noon.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of headache and chills was not reported. This report was non-serious.
Left side lymph node supraclavicular swollen; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 27Dec2020 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical history included irritable bowel syndrome (IBS), and human papilloma virus (HPV-16). The patient's concomitant medication included plecanatide (TRULANCE). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a public health clinic or veteran's administration facility. On 01Jan2021 at 08:00 AM, the patient experienced left side lymph node supraclavicular swollen 5 days after the injection. The event resulted in doctor or other healthcare professional office or clinic visit. At the time of reporting, it is still enlarged. It was unknown if treatment was given for the event. The patient underwent COVID-19 oral swab test by curative post-vaccination on 09Jan2021 that was negative. The patient had not recovered from the event.
Per Dr., pt was prescribed PENTACEL immunization, two-part vaccine not properly prepared, sterile diluent utilized instead of vaccine specific diluent. Dr. pediatrics lead, direct supervisor, and floor manager, notified of medication error. Per Dr. at no risk of ASE and needs to be revaccinated with PENTACEL.
The are of the left arm became swollen and had small hive like bumps and patient says that she was unable to lift her arm for a peroid of days.
Shortly after exiting the vaccination room, the patient felt lightheaded and dizzy and experienced an episode of near-syncope. She immediately lay down on the floor. She was sweating profusely. She remained on the floor for approximately 5 minutes with her legs raised and she started to feel better. She was given a bottle of orange juice to drink and was taken to the waiting area where she was observed for another 25 minutes. Patient stated that she felt fine and left the pharmacy.
administering the product in the wrong route with no adverse event; Initial information was received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered in the wrong route with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot UT8109KA, expiry date: 30-Jun-2024, strength, was unknown) via unknown route in unknown administration site for Influenza(Influenza Immunization) and had administering the product in the wrong route with no adverse event (incorrect route of product administration) (latency: same day).  It was reported "Nurse declined to provide any patient information. Only saying it was given a couple of days ago. FLUZONE QUADRIVALENT "  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore throat; Runny nose; Fatigue; This is a spontaneous report from a contactable consumer (patient's parent). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as second dose, single dose for covid-19 immunization. Medical history included ongoing obsessive-compulsive disorder (reported as His mother noticed some OCD symptoms yesterday which is common when his PANDAS is active). The patient's concomitant medications were not reported. On an unspecified date the patient experienced sore throat, runny nose, fatigue. The outcome of events was unknown.  Information on Lot/Batch number can be requested.
Adult flu vaccine (fluarix) given to my daughter instead of child's flu vaccine (fluzone).
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil. Immediately following the vaccination, the patient experienced dizziness, nausea and then fainted. The patient sought unspecified medical attention. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
administration of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 12 farenheit degrees for 15 minutes. No previous temperature excursion were reported.  On 14-OCT-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025205, expiration date: 13-AUG-2023 (strength, dosage regimen, anatomical location and route of administration were not provided) as prophylaxis.
pt recv vax; later that day, exp tenderness at inject site, tingling in arm,nausea,fatigue and blurry vision;
pt devel fever, exp dec appetite, not sleeping well; had ben ill w/RAD had audible breathing & was tachypneic on the day of vax; adm to hosp for observation & to r/o poss sepsis
Patient in for itchy red mostly papules and some vesicles on the face, trunk, upper and lower extremities for 2 days. Rashes are coming out not at the same time. She had her first Varicella vaccine on 10/09/2021 here at the clinic. No exposure to Varicella disease. The mother denies fever, cough, runny nose, fast or labored breathing, vomiting, diarrhea. No sick contacts. She saw Dr. yesterday because she was worried, but Dr. is not sure if it is chickenpox or a side effect of the Varicella vaccine. With 1 red papule on the forehead,  6 on the back, one on the right knee, one on the right leg; one vesicle on the right forearm and right cheek
No reaction for first 4 or 5 hours, increasing in pain until left arm and shoulder became immobilized. Severe pain when touched,  and slowly backing off after full 48 hours. It?s been 10 days and Left arm shoulder has about 85% mobility. Swelling in armpit also still present but almost gone.  I have a lock jaw kind of sensation still lingering as well.  No infection detected at injection point. Worried for dose two.
Patient and her husband came in and each wanted a flu shot and a shingles shot. We went through the screening process and the patients went to the immunization area. I came to go over their questionnaires and reconstituted the shingrix for both patients. While this was happening, I was being interrupted with questions and being notified that other patients were waiting in the pharmacy for immunizations and prescriptions. I took the vaccines to the immunization area and the patient was asking me questions. I realized after administering the vaccine in her right arm that I had accidentally administered a second shingrix instead of a Fluad. I apologized to the patient and asked her to wait at least 30 minutes so I could monitor for adverse reactions. The patient was feeling fine and seemed understanding and amicable when she left. I called the manufacturer and they said that the patient would still need a second dose in 2 to 6 months since the second dose was administered less than 4 weeks after the first. I told the patient I would check on her that evening and the next day. She did not answer the phone Friday evening. I will follow up the next day. Patient has not yet exhibited any adverse effects but an administration error did occur.
My body was achy. I have a history of migraines so I thought I just had a cold and migraine. Lack of appetite, sore body, very fatigued. The symptoms lasted 3-4 days, it started on he 20th and I started feeling better Christmas eve and was up and about the next day. Then I started with post-COVID-19 vertigo later that day. I'm still getting over this. I took Sudafed and Antivert, neither of these worked. My Dr. diagnosis me with post COVID-19 vertigo and I was given Valium and Prednisone.  I still have dizziness, fatigue and brain fog.
For 3 days pt had itching, scattered rash varicella like, and lymphdemopathy.
pt recv vax & approx 30min post vax pt devel a h/a;MD indicated that 8 other pt had similar exp (WAES97100694, 97100696 through 97100699 & 97100701 through 97100703);
Aching body, mild headache, and feeling warm to the touch.   Feeling of fatigue, tired, and generally lacking in energy.  Difficult to conduct normal work duties. Feeling of tired and fatigue lasted for two days after vaccine.   mild soreness at injection site,  nothing debilitating.
Fine slightly red rash on face, neck, and upper chest. Puffiness under eyes bilaterally, itching. Later in PM after starting steroids prescribed by Dr. had fever and n/v but was fine the next day.
72-year-old male with recent kidney transplant and COVID-19 presenting with worsening shortness of breath.  Patient arrives in respiratory failure.  Saturating mid 70s on non-rebreather.
My menstrual period ended about two days before the vaccination; however, it began again the night of the vaccination. Heavy bleeding. Fatigue. Still experiencing period - as if having a second period only two days after my last period ended.
Initial unsolicited report received from a pharmacist on 21 June 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 15 June 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date, following the vaccination the patient's left arm was swollen for 5 days and can't lift the arm as usual. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
no additional AE reported; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-MAR-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # S039319, expiration date 04-DEC-2021 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T022315, expiration date 30-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccines were stored in a temperature between - 50 degrees Celsius (C) to 8 C (-1.6 C) for 1 hour 36 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse event was reported.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. The vial was initially stored in the refrigerator- 01-DEC-2021. No temperature excursions.
I had my first flu shot ever this morning at ~10am and as of about 1pm I developed a mild cough reminiscent of ORS. I was confused at first because none of the flu shot symptoms I read about mentioned coughing (other than for the inhalant form of the vaccine). I did more research and discovered ORS, which I'm pretty sure this is (symptoms are not worsening, nor have any new symptoms arisen). Not even the advice nurse knew what ORS was. Other than the mild cough, I feel fine and will not be seeking treatment from a doctor.
20jul90 pt vax heptaB. pt ex v/n, chills, shaking, weakness, stiff neck, h/a, gastrointestinal cramps, dark stool, sweating, decreased appetite. tx w/ pepto bismol
Hair on head is falling out/thinning; gums bled more than usual during dental cleaning; slight incontinence that seems to be worsening (not associated with toileting).; This is a spontaneous report from a contactable nurse (patient). A 53-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (at the age of 53-years-old) as a dose 2, single for covid-19 immunization. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient previously took keflex [cefalexin monohydrate] and and sulfa [sulfacetamide sodium] and experienced drug hypersensitivity. Concomitant medications taken within 2 weeks of vaccination included canagliflozin (INVOKANA [CANAGLIFLOZIN]) and metformin (METFORMIN) both were taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 01:00 PM as a dose 1, single for covid-19 immunization. After dose 1, Patient experienced there was pain in my joints (knees and hip) and hematoma-like bruising on my palm after using a hammer (it disappeared after a couple days and left no residual markings). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date, the patient experienced Hair on head is falling out/thinning, gums bled more than usual during dental cleaning, slight incontinence that seems to be worsening (not associated with toileting). Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
I had a numbness in my hands and sharp pains from my lower back to my feet. Soreness all over to where it hurt to move
Double-vision while driving home.  Had to pull over and change drivers. Still double-vision while watching TV until about 12 hours later.
Mistakenly thought this was the adult vaccine and (without diluting) injected 0.3ml IM.
Arm was really sore the next day; Didn't feel good the day after getting the shot; Rash; Eyes were swollen; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of ad-ministration on 07Aug2021 (age at vaccination 60years old) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, autoimmune thyroiditis, Raynaud's phenomenon, Sjogren's syndrome, thyroiditis all from an unknown date and unknown if ongoing, covid-19 from Dec2020 to an unknown date Verbatim: She had COVID back on unspecified date in Dec2020. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine sodium (GENERIC SYNTHROID) taken for thyroid disorder, start and stop date were not reported; mirabegron (MYRBETRIQ); metformin (METFORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient experienced rash, eyes were swollen on unspecified date in Aug2021, and arm was really sore the next day, didn't feel good the day after getting the shot on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on Dec2020 She had COVID back in Dec2020. The clinical outcome of the event rash was recovered, and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Injection site, hot to touch, swelling, red welts appeared and extended approx. 6 inches around site. Reported should pain of "arthritic type"
Pt's O2 sats were at 60% at local clinic then transferred to local hospital. Pt. developed blood clot in both R leg and L leg and L lung; patient went to local hospital then transferred to larger hospital and stayed for 10 days and started on Eliquis.
30+ vesicular papules on face, numerous ones on back, trunk, arms. Onset 01/06/1997, low grade fever 100.
he was dizzy; can not stand in sun.; Throwing up 8 times from morning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (he was dizzy), PHOTOSENSITIVITY REACTION (can not stand in sun.) and VOMITING (Throwing up 8 times from morning) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (he was dizzy), PHOTOSENSITIVITY REACTION (can not stand in sun.) and VOMITING (Throwing up 8 times from morning). At the time of the report, DIZZINESS (he was dizzy), PHOTOSENSITIVITY REACTION (can not stand in sun.) and VOMITING (Throwing up 8 times from morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
FLuzone High dose vaccine was given to a 60 year old patient/No AE; FLuzone High dose vaccine was given to a 60 year old patient/No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 60 years old male patient who was given a 0.5 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] lot number: UJ499AB, expiry date: 30-JUN-2021 via intramuscular route in the left arm on 02-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No other vaccines was administered at the day of medication error.   It was a case of an actual medication error case due inappropriate age at vaccine administration and a case of overdose. (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
fever of 99.2; itchy and rash and hives inside legs by knees and elbows; itchy and rash and hives inside legs by knees and elbows; itchy and rash and hives inside legs by knees and elbows; This is spontaneous report received from a contactable consumer (patient) reported from Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included hydrocortisone acetate, neomycin sulfate, polymyxin b sulfat (CORTISPORIN). On 16Mar2021, six hours later started getting itchy and rash and hives inside legs by knees and elbows, today fever of 99.2. The patient underwent lab tests and procedures which included body temperature: 99.2 on 16Mar2021. The clinical outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.