chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Is a very pleasant elderly 88-year-old male who does not smoke denies any history of lung disease does have a history of some paroxysmal A-fib prior aortic valve replacement is on Coumadin who states that for the last week or so he has had increasing dyspnea.  He states that he just feels very weak.  He denies any chest pain or palpitations.  He denies any bruising bleeding or dark tarry stools.  He denies any cough congestion fevers or chills.  He denies any abdominal pain or problems urinating.  He states he has not had much appetite however has not been eating or drinking much.  He has been eating mostly ice cream and even that does not sound good.  He states he has a history of hypothyroidism and dyslipidemia as well.  He does not drink or smoke. Associated Symptoms: appetite changes, edema, fatigue, shortness of breath, weakness
This non-serious spontaneous case, was initially received on 23-Oct-2017 from a Pharmacist, concerns a 13-year-old adolescent female patient. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular and anatomical location: left deltoid). It was reported that vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was 40.6F last night but that morning the temperature was 55F and that was the first-time excursion. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. The reporter did not provide the seriousness assessment. Follow-up report received on 27-Nov-2017: Gender of the patient (female) was added. Routed of administration (intramuscular), anatomical location (left deltoid) was updated. It was reported that, the patient did not experience any adverse events after administration of the vaccine. Amended narrative accordingly. Significant case correction received with IRD 27-Nov-2017: The event 'no adverse event' was deleted.
Per mother (legal guardian) states had a seizure 7 days after the vaccine after being seizure free for over 10 years, not if related to the vaccine.
Fatigue and a feeling of being unwell.  Started after being awake for an hour or two and subsided by 2 pm.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. The healthcare professional reported that an unspecified number of improperly stored VARIVAX doses (dose, route and lot numbers not provided) have been administered to unspecified patients on unspecified dates. No adverse effects reported. Additional information has been requested.
it was rpt in 12/95 pt recv 1dose varivax & 5/98 pt devel 25 lesions. pt sought unspecified medical attn
Site: Pain at Injection Site-Severe, Additional Details: Cx received vaccination on12/28/2021 for pfizer shot. He did experience pain in his arm which wasn't unusual so he waited some time before he considered it a problem. Once his 2nd pfizer shot was due he went in for his appointment. The pharmacist there told him he should give it some more time before he gets the shot. He went to his doctor and they told him the same thing. still experiencing pain 2.5 month later
PROQUAD was accidentally mixed with Menactra and administered to a patient instead of Adacel; PROQUAD was accidentally mixed with Menactra and administered to a patient; This spontaneous report was received from a nurse regarding an 11 year old, male patient.  No information regarding concurrent conditions, medical history was provided. It was reported the patient received a concomitant vaccine for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis on an unknown date.  It was reported that on 26-FEB-2021, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live  (PROQUAD) was accidentally mixed with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and administered to the patient instead of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) on the right arm for prophylaxis(wrong product administered and product preparation error) (Lot, expiration date, vaccination scheme and route of administration was not reported.)   At the time of the this report, no adverse event was reported.
FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Chills within 24 hours of 2nd dose. Hives to bilateral thighs within 72hrs, resolved with Benadryl. Occipital headache, dizziness, sweats, nausea, anorexia, ear pressure within 72 hours after 2nd dose.
diarrhea; This is a spontaneous report from a non-contactable consumer reporting for himself. An 88-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing rhinorrhoea, ongoing lacrimation increased, tooth loss and ongoing viral infection. Concomitant medication included plantago ovata (METAMUCIL). The patient experienced diarrhea on 16Jan2021 with outcome of unknown. No therapeutic measures were taken as a result of the event.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pain on lower left side; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on lower left side) and PYREXIA (Have fever) in a  patient of an unknown age and gender 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 an unknown date, the patient experienced PAIN (pain on lower left side) and PYREXIA (Have fever). At the time of the report, PAIN (pain on lower left side) and PYREXIA (Have fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
I foolishly had flu shot and pneumonia booster injected into same arm. Five hours later, excruciating pain and for days could not move my arm. Pain was controlled with OTC meds but took many days to abate. I do not think the clinic should innoculate 2 shots in the same arm. It's also possible that the shot was given too deeply and went into the bursa in the shoulder (per the orthopedic doctor that I went to to be checked over 1 1/2 weeks later). I don't want to get anyone in trouble but I would hate to see anyone go through what I went through. I would never recommend an older person have both shots in the same arm, and maybe not even on the same day.
PATIENT HAD 2 SEIZURES IMMEDIATELY AFTER ADMINISTRATION WITHIN 5 MINUTES. PATIENT WAS OFFERED 911/EMERGENCY MEDICAL SERVICES, BUT REFUSED. PHARMACIST STAYED WITH PATIENT FOR APPROXIMATELY 15 MINUTES AND THEY LEFT WITH A FRIEND. ENCOURAGED EMERGENCY MEDICAL SERVICES, UNKNOWN IF PATIENT WENT.
Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day on Friday the aches increased.  Slept quite a lot.  Took Tylenol and Advil, alternating them and then at bedtime took 1 of each.  Joint aches have decreased on Saturday, but the fever and chills are still coming and going.
Fever; Almost threw up; Retching; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date. Concomitant products included METOPROLOL, AMLODIPINE, ATORVASTATIN, SILDENAFIL, HYDROCHLOROTHIAZIDE, B-COMPLEX 2000, UBIQUINOL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN), ZINC and MAGNESIUM.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching). On 16-Jan-2021, PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching) had resolved. Not Provided      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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405usa012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J004387 and exp date 04-JAN-2015 (also reported as 31-JAN-2015) which was stored improperly (highest temperature: 8.5C, number of hours prior to administration: 15 minutes (min)) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
This spontaneous report was received from a pharmacist referring to a 69 year old female patient. The patient had no historical condition, concomitant medications and drug reactions or allergies to be reported. On 22-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular for prophylaxis (reported as vaccination) lot # N013521, and expiration date 23-JUN-2019 (dose and anatomical location were not reported). The pharmacist reported that patient returned on 24-OCT-2018, and explained that beginning on 23-OCT-2018, it hurt to pick up her arm (pain in arm). Pharmacist also reported that there was swelling at the injection site (injection site swelling), redness (injection site redness), and the site was "hot to the touch" (hot at inj site post vaccination). Also reported that the patient applied ice to the affected area for an unspecified amount of time, and patient took an unspecified dose of ibuprofen (MOTRIN) for pain. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The causality between injection site swelling, injection site warmth, injection site erythema and pain in extremity and PNEUMOVAX 23 was unknown.
This spontaneous report as received from a nurse refers to a 6 months old patient. The patient was vaccinated with the third dose of RECOMBIVAX HB (Lot # and exp date unspecified) (vaccination site unknown) "3 days earlier" on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
swelling Injection Site; Itch  Injection Site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site) in a patient of an unknown age and gender 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 VACCINATION SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site). At the time of the report, VACCINATION SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
This spontaneous report as received from a health professional (medical assistant) refers to a 17 year old patient (unknown gender). No concurrent conditions, medical history or allergy/drug reactions were reported. On 06-AUG-2015, the patient was inadvertently given a dose of ZOSTAVAX lot # L011533, exp. date: 03-JUL-2016 (strength and dose unspecified) via intramuscular administration instead of (Oka/Merck) VARIVAX. No concomitant medications were reported. No adverse effect was reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further information was provided. Additional information has been requested.
he's have colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2023, outcome "unknown", described as "he's have colds".  Additional information: Caller's concern: Caller said on 25Sep he got his Comirnaty vaccine shot at Pharmacy, and the person who gave him the shot said to come back in Nov2023 for his second shot as he's going to need two of them. The caller went online and tried to see information but didn't see anything that talks about a second shot. The caller would just like to make sure of the dosing of the vaccine because he thinks he's misunderstanding the dosing schedule for ages 12 and older in the 2023-2024 formula. Resolution: Transferred call from one of the health and science representatives and had a patient who had called her. Caller had mentioned he's have colds and not sure about the second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused vertigo for a short time the next morning.  Neck lymph node swollen for 3 days. Armpit is still swollen. Aches, joint pain, fatigue, fever 101 have resolved. Nausea continues.
expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st March 2022) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: Medical assistant reporting, expired Menveo administered to the patient. Healthcare professional declined to provide any adverse event information. Additional supportive information: The patient received expired dose of Menveo, which led to expired vaccine used.
About one and a half days after taking flu shot, employee experienced a generalized rash over entire body and his eyes became bloodshot.  The rash was accompanied by non-severe itching.  On 12/3/14 the rash is fading and itching has subsided.  Eyes remain somewhat reddened.  Employee did not seek medical help.
SYNCOPE AND FELL TO THE FLOOR AFTER 5 MINS WAITING IN THE SEATING AREA . WOKE UP WITH IN A MINUTE.
Expired MMRV vaccine (expiration 1/16/2023) was given to patient on 1/17/2023
This spontaneous report as received from a receptionist via a field representative refers to a 17 year old female patient who was not pregnant. Patient's medical history and drug allergies were not specified by the reporter. On an unknown date (reported as years ago), the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not specified by the reporter). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced ongoing seizures after receiving GARDASIL. The reporter stated that seizures had been ongoing for multiple years and that the patient was having metal removed from her (date not specified), but it could not be confirm what metal fragments was being removed from the patient's body. It was reported that the patient experienced significant disability or incapacity due to the adverse events. It was not specified by the reporter if any treatment was given for the adverse events. Laboratory tests were not specified by the reporter. The patient sought medical attention by an unspecified office visit. Product quality complaint (PQC) was not involved. The patient did not recovered from the adverse events at the time of the report. Causality assessment was not provided. Upon internal review the event of seizures was considered to be medically significant. Additional information is not expected due to lack of physician's contact details.
HARD LUMP AT SITE OF INJECTION, APPROXIMATELY 5 INCHES IN DIAMETER. NO REDNESS, WARMTH, FEVER, SWELLING OF THROAT, NOR ITCHING. RECOMMENDED TO WATCH SITE EVERYDAY; THE LUMP WAS GOING AWAY
She's having an allergic reaction; My eyes are swelled; I'm having hives on different parts of my body; ears are hot; itchy ears; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She's having an allergic reaction), EYE SWELLING (My eyes are swelled), URTICARIA (I'm having hives on different parts of my body), ERYTHEMA (ears are hot) and PRURITUS (itchy ears) 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 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERSENSITIVITY (She's having an allergic reaction), EYE SWELLING (My eyes are swelled), URTICARIA (I'm having hives on different parts of my body), ERYTHEMA (ears are hot) and PRURITUS (itchy ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (She's having an allergic reaction), EYE SWELLING (My eyes are swelled), URTICARIA (I'm having hives on different parts of my body), ERYTHEMA (ears are hot) and PRURITUS (itchy ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that symptoms seem to be getting worse as time passes. Treatment medication include:Ice   Reporter did not allow further contact
Patient reported lightheadedness and nausea directly following administration of AFLURIA PF. Patient appeared nervous and tense before and during administration of the shot. Water was offered to the patient, which he accepted, and after resting for 5-10 minutes, the patient said he felt better and left.