chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 month old female who on 15, Jan 2007 was vaccinated with a dose of measles virus vaccine live ((Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 656170/1400F). On 24, Jan 2007, the patient experienced a fever. On 25, Jan 2007, the patient experienced a rash form head to toe. The patient's fever and rash from head to toe persisted. Unspecified medical attention was sought. Additional information has been requested.
BODY PAIN; HEAD IS SWIMMY/LIGHT-HEADED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included no known allergies no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced body pain. On 13-MAY-2021, the subject experienced head is swimmy/light-headed. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, body pain, head is swimmy/light-headed, and chills. This report was non-serious.
Nausea and vomited 10 min after injection B.S. 55 given 8 oz. Gatorade and pretzels. B.S. increased 115 and discharge. Vomited x2 after returning dorm room. Came to be seen after last episode vomit. Frontal HA. No fever. Felt weak slept for 2 hours in health center - felt better. 16 oz Gatorade feeling well.
INJECTION SITE SWELLING; Its Red,Redness is getting bigger and bigger and bigger; Its itchy; Its getting hard; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) in a 77-year-old female 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 medical history is reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard). At the time of the report, VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.    Reporter did not allow further contact
10/20/12 no fever, swelling of right arm (feel like a rock) painful on day 1. 10/21/12 swelling and redness spread throughout the upper arm.
bloody eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (bloody eye) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (bloody eye). At the time of the report, CONJUNCTIVAL HYPERAEMIA (bloody eye) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of  unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #L024132 exp date 21-JAN-2017 and lot # L035686 exp date 16-FEB-2017) (dose and route not reported). NO adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and current conditions were not provided. On an unknown date the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot # L033697, expiry date 28-FEB-2017. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Headache the following day that her persisted for 6 days. Improves with analgesics.
consumer was given Fluzone Quadrivalent 0.5 mL that was expiredwho was 35-weeks pregnant, no AE; consumer was given Fluzone Quadrivalent 0.5 mL that was expired, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 34 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U63O2AA, Exp. Date 30-Jun-2019) via intramuscular route in the left deltoid, on 24-Sep-2019 and was 35 weeks pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period at onset was reported as 35 weeks. The date of last menstrual period was not reported. The estimated due date is 27-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing gestational diabetes.  It was a case of actual medication error due to expired vaccine used.  It was also a case of vaccine exposure during pregnanacy.  It was reported that a consumer was given Fluzone Quadrivalent 0.5 mL that was expired. The caller reported that the consumer received the dose on the morning of 24-Sep-2019, the vaccine expiration was on 30-Jun-2019. The consumer is 35-weeks pregnant.  At the time of reporting, no adverse reactions were reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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 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.  List of documents held by sender: none.
Meniere's Disease; ear infection; Autoimmune response to the vaccine; headaches; facial pressure; tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced FACIAL DISCOMFORT (facial pressure), TINNITUS (tinnitus) and HEADACHE (headaches). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine). At the time of the report, MENIERE'S DISEASE (Meniere's Disease), FACIAL DISCOMFORT (facial pressure), EAR INFECTION (ear infection) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) outcome was unknown and TINNITUS (tinnitus) and HEADACHE (headaches) had not resolved.            On unknown date, the patient was given antibiotics for a possible ear infection and the ears, nose and throat (ENT) physician put the patient on prednisone.  On unknown date, the patient was seen by a neurologist for the persistent headaches and tinnitus and was told by the doctor the patient had an autoimmune response to the vaccine that was affected the nerves.  This case concerns a 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 35-year-old male with a serious unexpected event of Meniere's disease, and nonserious unexpected autoimmune disorder, tinnitus, ear infection, facial discomfort, and expected headache. Event onset with unknown after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Nauseated, lightheaded, and warm; had fever of 100.1F the next day with fatigue
Sudden onset of tinnitus with hearing loss in right ear. Starting at 0200 on 01 April 2021.  Tinnitus and hearing loss is ongoing.  Tinnitus has decreased in intensity, but there was a sudden increase of tinnitus the evening of 08 April 2021, the same day that I received the 2nd vaccine dose. Hearing loss in right continues. Minor hearing loss in left ear was detected with audiology testing also.
I had Shingrex 2 of 2 around 11 a.m. I woke up at ll:30 pm feeling nauseous and completely unwell.  Weak. Left injection arm EXTREMELY sore. It has been 54 hours since the vaccination and I am just now feeling decent.  Not yet strong, but much better.  Hope tomorrow ill be close to normal.  I've been in bed for most of two days.
This spontaneous report was received from a pharmacy technician referring to a 15 year old male patient. The patient had no concurrent conditions, medical history and no drug reaction or allergies to be reported. On 02-JUN-2016 (also reported as 06-JUN-2016) the patient was vaccinated with the third dose of GARDASIL 0.5 ml, lot # L040460, expiration date 27-MAY-2017, intramuscularly. Other suspect therapies include sterile diluent (manufacturer unknown) (dose unknown) lot # reported as L045726, expiration date: 26-MAY-2018 (not valid for sterile diluent but valid for GARDASIL), administered on 02-JUN-2016. Concomitant medications were not reported. The pharmacy technician reported that when the medical assistant administered the vaccine, she added an unspecified amount of sterile water diluent (manufacturer unknown) to the 0.5ml dose of GARDASIL. It was also reported that the patient experienced pain at the injection site immediately after the vaccination that lasted for an unspecified duration and resolved on an unspecified date in June 2016. No laboratories were performed. The causality between pain and GARDASIL was unknown. Additional information has been requested.
OFF LABEL USE; ACCIDENTAL EXPOSURE TO PRODUCT; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; .This spontaneous report received from a health care professional concerned a 17 year old female. 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, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 12:03 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced accidental exposure to product. On 30-APR-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, accidental exposure to product and product administered to patient of inappropriate age was not reported. This report was non-serious.
Pt woke in the middle of the night with lots of pain in the vaccination arm, and a near inability to move it due to the pain. The patient got mild relief from Tylenol. Pt was instructed to continue dosing Tylenol, as the pt was now able to move the arm, just having pain, and to be seen if pain continued or symptoms worsened.
Hand palms feel severely sunburned and are hyper sensitive; Hand palms feel severely sunburned and are hyper sensitive; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received first dose BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206 and Expiration Date not reported) via an unspecified route of administration, in Arm Right on 03Mar2021 19:15 as 1st dose single dose for COVID-19 immunization. The patient medical history included rheumatoid arthritis, asthma, gluten allergy and overweight. The patient concomitant medications were not reported. The patient has the known allergies. The patient did not receive other vaccine in four weeks and received other medication in two weeks. The patient did not have COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 05Mar2021 08:00 AM, the patient hand palms feel severely sunburned and were hyper. Her Sole of right foot and arch was the same as hands. The patient did not receive treatment for the events. The outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
apx 20 hours after administered a site reaction was noticed including redness, swelling, soreness and area was hot to the touch.  A moderated fever was present at this time and continued to increase.  Within 48 hours all over stiffness and body aches, lasting several days. Most alarming for the pt was a remarkable change of mood and behavior, including irritablity, hostility and aggression that has been increasing as of 10/12/05 and has not subsided with the stiffness and soreness.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 2/11/2022 METABOLIC ENCEPHALOPATHY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/1/2021 METABOLIC ENCEPHALOPATHY
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted within 15 minutes after receiving a covid vaccine. Patient laid on the floor and a minute clinic provider was with the patient until the emt arrived. Patient did not want to go with the emt to the hospital. Minute clinic provider stayed with patient until EMT arrived and was okay with patient going home as long as she got a ride. Her dad came to pick her up. Patient had not eatten prior to vaccination.
tonic sz >40min w/eye deviated, required  meds to stop;w/in 2hr recurred required med again;
Wheezing, hives, urticaria 1-1 1/2 hrs after imms. adm. Benadryl PO, Prelone PO, nebulization Tx responded to Tx.
DAY AFTER VACCINE RECEIVED, IN THE EVENING, EMPLOYEE DEVELOPED ITCHING, "HIVES" ON LEGS AND RASH ON CHEST.  VACCINATION SITE WAS SWOLLEN AND ITCHY.  SYMPTOMS LASTED INTO DAY 2 POST VACCINE .  EMPLOYEE ACCEPTED BENADRYL 25MG X 2 TABS, HOWEVER EMPLOYEE WANTS TO ONLY TAKE 2ND TAB IF SYMPTOMS NOT RELIEVED. WITH FIRST TAB
approx 5min p/shot pt note to be pale, listless w/sl grunting resp & dec tone spontaneously resolved w/in 3-5min to nl color, tone & activity, resp easy-no intervention done;no sz activity;
pt recv vax & broke out w/rash on buttocks;noted gen round reddened raised rash all over;vomiting;
pt experienced heart pounding, throat hurt (felt swollen) temples throbbing (lasted 20 min),  dizziness (lasting week) and nausea.
Patient reports swelling/tightness of forehead that appeared one day after vaccine and lasted 1.5 days.
On 1/14/2021 ( about 14 days from dose # 1) Tachycardia of unknown origin, 120 BPM for 6 hours, Called Cardiologist and was seen @ MD next business day, and given EKG and Bystolic 10 MG to "add" to daily regimin IF it returned. It retuned to normal after 6 hours, and then occurred again 1 week later...for 6 hours. I took Bystolic, and about 8 hours later it returned to baseline (about 62/min.  on Sun 1/24/2021, I woke up to bloody diarrhea x several episodes...this continued until Wed 27th, at which time my son (a 4th year graduating MD student) drove me to hospital and I was seen in ER room by MD. I was admitted, and had emergency surgery 1/27/2021 straight from Er Room. I had life saving surgery the next day to stop a lower GI bleed (of unknown origin). I was discharged 3 days later, and I am awaiting more testes, appts, etc.... I have lost time, money, and work from this near death experience... and the tachycardia still needs to be followed up on . I am EXTREMELY upset by these events, as I almost died....was hospitalized, incurred a lot of expense, used up all my sick pay and personal days, and out-of -pocket to my healthcare insurer.
felt winded and had shortness of breath; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA332246.  This case involves a 64 years old female patient who felt winded and had shortness of breath after receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for Prophylactic vaccination (Immunization).  On 13-Oct-2023, the patient received unknown dose of suspect YELLOW FEVER VACCINE - (Solution for injection) (frequency: 1X and Drug Treatment Duration: once) (lot UJ829AA and expiry date: 30-Nov-2024) via subcutaneous route in the left arm for Immunization.  On 18-Oct-2023, the patient felt winded and had shortness of breath (dyspnoea) 5 days following the administration of YELLOW FEVER VACCINE.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Vertigo.  I have had vertigo before, so it may be unrelated, but I have debris in both ears this time and it?s been a different experience.
Auras in both eyes occurred followed by a headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included Grave's disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and prenatal vitamins (unspecified); both for unknown indication from unknown date and unknown if ongoing. On 22Apr2021 at 12:30 (also reported as one day after vaccination), the patient experienced auras in both eyes that occurred followed by a headache. This happened once a day for the next three days. Four days passed and then it happened again. The patient stated sometimes weeks go by before it happened again. It still happened as of today (at the time of the report). The patient never had migraines and this had never happened before the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event auras in both eyes occurred followed by a headache was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-JUN-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 0515AA expiry date 08-APR-2013; strength, dose, route and site unspecified). No adverse effect was reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 4 patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 24-NOV-2014 the 4 patients were vaccinated with doses of improperly stored PEDVAX HIB (lot#, dose, route and frequency were not provided). No adverse effect was reported. Additional information has been requested.
Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF, A.Fib contributory.