chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vascular dementia; Had a reaction; This spontaneous case was received on 06-Jan-2021 from a pharmacist via Health Authority (reference number: SEQW21-00057) with additional information received on the same date (reference number: SEQW21-00058) (being processed together) and concerned an elderly, male patient. At the time of this report, the patient was an 84-year-old.    The patient's medical history and concomitant medications were not reported.    On an unknown date in 2018, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number was not reported.    On an unspecified date in 2018, unknown amount of time after receiving Fluad (TIV), the patient had a reaction at that point, but the reporter did not know what kind of reaction.   On an unknown date, the patient was diagnosed with vascular dementia that got worse and was now in a nursing home.    The reporter did not provide causality assessment. The reporter stated patient was diagnosed with vascular dementia, but they were not sure if this was related to the vaccine.   At the time of initial reporting on 06-Jan-2021, the patient had not recovered from the event of vascular dementia.   The outcome of event 'adverse reaction' was not reported.   The event of vascular dementia was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.; Reporter's Comments: The reporter stated patient was diagnosed with dementia, but they were not sure if this was related to the vaccine.; Sender's Comments: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.
Reaction first appeared 8 days after 1st dose was administered. Area was very red, hot to the touch, multiple raised bumps, not evenly dispersed. Area extended from where injection was given, upper arm near shoulder and extended halfway down the left arm. Took Claritin and ibuprofen which both seemed to help. By day 3, redness had gone down and less heat radiating from site.
fever, chills, diarrhea, vomiting for 3 days. dizziness with nausea, tinnitus, ongoing fatigue, sharp intermittent generalized body aches, inability to focus and multitask, frustration with over stimulus, activity intolerance
Fatigue, malaise, generalized myalgias, headache, back pain, neck pain.
Parent called to report temp. of 104.9F, vomiting and redness, swelling at site of immunization. Pediatrician advised mother he felt it was local reaction but that infant also had viral illness, causing vomiting and temp. On 4/13/00 it was reported that the chld was improving and symptoms had almost completely resolved.
Approximately 24 hours post flu vaccination, patient developed left sided facial numbness and tingling that started near her mouth and moved to the upper aspect of her face. Noted to have left sided mouth drooping.
pt recv vax 30MAY96 & mom states pt cried & screamed for 4hr p/vax;mom reporter rxn w/next visit not @ time of rxn;
Fever greater than 102, dizziness, chills, shivering, aching, hard to walk, nausea
rash in the top of his mouth, across his face and around his ears/ shingles outbreak; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September of 2016, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), for routine health maintenance and for its intended purpose: the prevention of shingles. In or around February of 2017, pt presented to the clinic with complaints of a rash in the top of his mouth, across his face and around his ears. The shingles outbreak lasted several weeks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using the product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the event was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
fever, chills, April 2-6.   Then hives at injection side and down arm to elbow starting April 7 and resolved April 11.
felt completely fine 15 min after shot. 1230pm arm stopped hurting where shot was given. started to feel sore & achy in left lower arm not sure exact time this started. around 2pm, left lower  arm start to get numb and move  into  my hand  & fingers. it would come, then subside and started to come more frequent and worsen. 3pm started to feel shortness of breath and very deep bronochial cough & noticed my left arm & hand was turning purple. 2 took puffs of albeurtol. called my allergist & could not get a hold of him. took car service to urgent care. got to urgent care at got very dizzy, left hand fingers were blue and entire left arm numbness, r/hand purple dropped to the ground in waiting area of urgent care , coughing got worse and 2 nurses tended to me and rush me to exam room.urgent care  called ambulance to take me to ER
Pt developed redness/edema at injection site noted within 24 hours post vax. (1.5 X .75 inch area) Pt was treated with Benadryl, analgesics and warm compress.
This spontaneous report as received from a healthcare professional regarding unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9, lot no. L035105/expiration date-14-MAY-2017 (incorrect product storage). No adverse event was reported. Temperature of exposure was 52 F, time frame was 840 hours and call was not because of digital data logger and there was no previous excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Ground level fall 3/5, injured arm. Was seen in ED, discharged.  ED visit next 3/7 dizziness, fell hit shoulder, dislocated. Patient could not walk, had difficulty swallowing. Admitted for observation.
she is suspecting that she had covid.; she is suspecting that she had covid.; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she is suspecting that she had covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
22 min post vaccination c/o of nausea and light headedness and shortly thereafter started with emesis.  Pt alert and oriented and without signs/symptoms of anaphylaxis including no respiratory distress, urticaria, or angioedema.  Pt given 8 mg Zofran 40 min post vaccination without effect followed by 12.5 mg diphenhydramine 55 min post vaccination without effect. Emesis continued throughout but without worsening or other symptoms.  Pt transferred to ER by facility administrator for further evaluation 80 min post vaccination.   Pt monitored with O2 sat and at 99% throughout and BP taken aprox every10 minutes with SBP ranging from 128 to 152.  Pt w/ tachycardia during most of monitoring ranging from 113 to 131.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 22Apr2021 as dose 2, single (Lot number: EW0170) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Dec2021 as dose 3 (booster),single (Lot number: 013F21A), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN, start date: 25Jul2022, stop date: 28Jul2022; TERBINAFINE, start date: 01Mar2022; BUPROPION, start date: 01May2022; LEVOTHYROXINE, start date: 06Jun2022; FLUOXETINE, start date: 17Apr2022; LORATADINE, start date: 01Jan2022; CALCIUM CITRATE, start date: 01Jan2022; PREGABALIN, start date: 01Aug2021. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergy: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: Positive test 10 days after completing Paxlovid (01Aug2022). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received COVID 19 treatment with Paxlovid on 25Jul2022 and stop date was 29Jul2022.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from registered nurse refers to an adult female patient of unknown age. The nurse reported that an adult female received a dose of ENGERIX-B, 10 mcg, which is a pediatric dose; however, the confusion arose as the practitioner believed that ENERGIX-B corresponded to the same dosage guidelines as RECOMBIVAX HB, which is 10 mcg in a 1 ml dose for adults. There was no product lot number or expiration date available. RECOMBIVAX HB was chosen as the AE product as it was the product whose dosing formulation the nurse confused with the ENGERIX-B. No adverse effect reported. No additional information available. Additional information is not expected as permission to contact the physician was declined.
Crying inconsolably from 13:00 to 19:00 (6 hours). Fed only 1 oz. Distraught and in pain at injection site. Short 5 minute naps with waking and shrieking. No fever.
Information has been received from a nurse concerning a 54 year old male patient in her practice who on 03-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669406/1357Z, Exp 15-JAN-2012). The nurse reported that the patient experienced low grade fever, injection site redness and pain after receipt of ZOSTAVAX (Merck), the patient went to see doctor. At the time of the report, the status of the patient was not reported. This is one of several reports received from the same source. The nurse requested a lot check for this lot number. A lot check has been initiated. Additional information has been requested.
Hot to touch, egg-shaped, slightly raised lump with 3 to 4 inches rash around lump, very itchy.
LPN, administered Proquad that was stored in the refrigerator instead of the freezer.
PARENT OF PATIENT CALLED CLINIC WITH PATIENT COMPLAINTS OF COASTER SIZE REDNESS AT INJECTION SITE, WARM TO TOUCH & UNABLE TO MOVE LEFT ARM WITHOUT PAIN.
felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ILLNESS (felt sick) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported: naproxen. No concomitant medications reported.
CHILL; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male 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: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced chill. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fatigue, and chill. This report was non-serious.
No additional adverse effect reported; On 13-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
I received my 1st dose of the moderna vaccine on 1/20/21 around 9:15am. I had normal site soreness and a very small raised area. All that went away within 3-4 days.  Yesterday 1/27/21, exactly 1 week after my injection I noticed a larger raised area that was raised, red, warm to the touch and slightly itchy. The area is currently around 2"x1".   I am 38 years old and pregnant with our second child. I received the 1st dose at 33 weeks and 5 days pregnant. Today we are 34 weeks and 6 days. Baby's estimated due date is March 5, 2021.
6.5 x 7 deltoid LUA SQ erythema c/o HA, cough, nausea -alternate, heat/cold to site acetaminophen 325 x 2 q 6hr prn fever/pain
Significant swelling at injection site-more than 3?, 2? circular rash at injection site, severe headache, severe abdominal pain, fatigue, dizziness, room spinning, significant soreness at injection site, inability to lift dishes into a cupboard.  Had to call paramedics about the severe abdominal pain. Was concerned because I?ve had gastric bypass surgery and I thought I might have a blockage.  Paramedic felt it was likely due to receiving the vaccine. Decided to see if it would resolve and it did eventually.  Took Tylenol for soreness and headache.
feels very itchy; systemic hives over her whole body from her neck to her toes; flare up; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for an unknown indication.    No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up). At the time of the report, PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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
Pt tested +for COVID on 5/13/21 with mild symptoms.  Lives with girlfriend who also tested +for COVID after being fully vacinated
pt recv vax 15DEC95&30DEC95 exp URI/cold sx specified as h/a,bodyaches,& myalgia&started to notice red spots which spread over arms,chest,face&scalp;It was noted that pt had approx 15 pox;
c/o red swollen, painful to touch lt arm; 36 hrs post vax c/o fever, chills, h/a, vertigo, nausea & diarrhea;
Patient attended a flu shot clinic at his place of residence on October 11, 2021. The above flu shot was given on that date in the left deltoid. The nurse returned on November 5, 2021 and the patient approached the nurse requesting another flu shot, which was given in the right deltoid. Nurse was unaware that the patient already had a flu shot on October 11, 2021. It was discovered later, when the information for the November 5th injection was put into the computer by the pharmacy personnel. The patient never had any known complaints.
This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 07-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, and lot number were not reported, the expiration date of the vaccine was June 2018) for prophylaxis. Then, on an unknown date in May 2107, the patient experienced a rash. Subsequently, the patient experienced arm swelling and tenderness and was seen at an emergency room. At the time of this report, the outcome of the rash, arm swelling, and tenderness was unknown.  The causality assessment between rash, arm swelling and tenderness with PNEUMOVAX23 was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Pt developed swelling feeling of tongue and throat closing up; given epi-pen with some improvement and 911 called
This spontaneous report was received from a nurse and refers to a 43 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 23-NOV-2015, the 43 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 23-NOV-2015, the 42 year old patient was vaccinated with a dose of ZOSTAVAX lot # L015417, expiration date o1-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
1999 - Recieved vaccinations (series of 3).  Within same year, treated for multiple urinary tract infection, heart palpitations, and unexplained skin rash on same arm that received injection, as well as on the neck and small patch above the right eye.  Prescribed a treatment of steroids and prescribed Fluocinonide cream for flare ups.  Rash is still present to this day on right arm and above right eye.  Developed lactose intolerance and digestive problems.  Over the last 3 years, multiple unexplained symptoms to include weight loss, raynauds symptoms, heart palpitations, digestive difficulties, urinary tract infections, skene's gland cyst, myxoma tumor in right thigh and dermographism.  ANA positive and anemic.  Diagnosis has not yet been received; however, UCTD and immune system injury are being considered.
Patient passed out briefly a few minutes after receiving the vaccine. Nurses evaluated patients orientation, oriented x3, vitals, within normal limits.  Last food or drink a banana earlier that morning Called EMS who cleared patient to leave.  Patient did not go to the hospital.
Day 2-swelling at injection site, and redness. Day 3-+ shoulder joint pain (left). Day 4-+ shoulder joint pain (right). Day 5-+ wrist and thumb joint pain (left). Day 7-+shingles on lower back, severe itching.
Red Rash appeared about 1 1/2 hours post vaccination.  Itching was present.  It resolved on it's own about 1 hour later.  No medication or treatment was needed.
Patient started having blood in stool at 5:00 p.m. in the evening on 7/11/08 after receiving Rotavirus and Pediarix vaccine. Patient has had blood in stools at least 1 time everyday sometimes 2-3 times everyday since the first episode on 7/11/08. Patient's sees Dr. Mother states all tests doctor has performed have been normal. Mom states child has an appointment with a gastro specialist on 9/2/08. Mother states the blood in the stool looks like a red string. States child's doctor thinks the blood may be due to something other than the Rotavirus vaccine because of the duration of symptoms.
AFTER ADMINISTERING MODERNA 1ST DOSE @ 1747, ABOUT 5 MINUTES LATER PT'S FELT DIZZY, SWEATING, HAD SOME WATER, PT'S WAS WITH MOTHER, PT'S SAID HE FAINT , OR FEEL THIS WAY EVERY TIME HE GETS VACCINE BECAUSE PT'S IS AFRAID OF NEEDLE. PT'S JUST WANTED SOME WATER AND SAID HE IS GETTING BETTER. @ 1810 PT'S TOOK TYLENOL 500MG (2 TABLETS). PT'S FELT ALRIGHT TO LEAVE ~@1815; MOTHER SAID SHE WILL DROP OFF HER SON AND BE WITH HIM. PT;S FEELING FINE TO LEAVE PHARMACY WITH MOTHER. DP 01/03/2022