chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eight days after receiving the vaccine I began to itch on my upper legs, trunk and chest. The itching became very intense my skin had a rash in some places. The itching literally was worse than anything I had ever experienced. Though I was given vistaril, the only thing that would give me the smallest relief was the over the counter calamine spray. The itching finally began to subside about 9 days after it began. The only thing I could contribute this to was the Covid vaccination because it was the only thing different in my routine.
Redness and swollen on Right arm. Tender to touch and was given AUGMENTIN 250/125 mg #30 tab only.
Visual disturbance: kaleidescope vision outside area of focus, strobe effect in peripheral vision.
Information has been received from a physician concerning a 12 year old female who on 01-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided).On unspecified date in December, 2006, the patient separate two periods (dates not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (COZAAR), INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugars higher, has always been stable on insulin dose but now it is out of whack, A1C higher by 0.3) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Glycosylated haemoglobin: higher by 0.3 (abnormal) higher by 0.3.         Treatment details included none yet, but the patient reported following up with HCP about need to change insulin dosing.  Company comment: Very little information is provided for this case and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Very little information is provided for this case and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Information has been received from a 76 year old female, with no medical history and no allergies , who on 31-OCT-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 01-NOV-2007 the patient developed a rash under her breast, arms, legs, and on her stomach. "After a few days", on approximately 03-NOV-2007, her blood pressure was increased, she had a mild headache and nausea. At the time of the report the patient has not recovered. There were no laboratory or diagnostic tests performed. Medical at attention was not sought. No product quality was involved. No other information was provided. Additional information is not expected.
after 3hrs, she felt a sore in her arm; This is a spontaneous report from a contactable consumer, patient.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced after 3hrs, she felt a sore in her arm on 02Mar2021.  The outcome of the event, after 3hrs, she felt a sore in her arm was unknown.   Information on the lot/batch number has been requested.
About one hour after my J&J vaccine, I experienced dizziness. I took a shower and felt chills all over my body and back pain as well. I then  went to sleep and my head started to hurt. My head pain grew in intensity and I felt dizzy. At about 7pm, I started vomiting profusely because of my headaches. I then went to urgent care because I am also diabetic and was worried of how I was feeling. At the urgent care they gave me Paracetamol and nausea medication. My headaches lasted 3-4 days then they went away. Also since I was on my third day of my menstrual cycle at the time of my J&J vaccine, my menstrual cycle got irregular and lasted 5 days longer than my usual 3 days.
Tender, red swelling of 6 cm diameter developed approximately 24 hours after injection. Seen at 48 hours and local supportive care with cold compress then warm compress.
really sick for a few days; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves patient (unknown age and gender) who was really sick for a few days (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination included flu shot and got really sick in the spring.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported, in the fall for years) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) after vaccination with INFLUENZA VACCINE, the patient never got the flu. But in the spring would get really sick for a few days (illness).  Also reported that: For the last few years patient had not gotten a flu shot and have not gotten the flu and had not gotten sick in the spring.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event illness.  There will be no information on the batch number for this case.
Tingles in mouth about 15 minutes after injection, itchy mouth and need to clear throat about 20 minutes after
Injection site swelling.  Information has been received from a pharmacist concerning an 84 year old female who on 11 JUL 2007 was vaccinated with a .65 ml dose of zoster vaccine live (Oka/Merck) subcutaneously.  On 14 JUL 2007, the patient experienced injection site swelling:  2.5 inches, which persisted.  Outcome was not reported.  No further information is available.
The following morning I woke up with a headache; The following morning I woke up with a headache, that progressed into lack of appetite; The following morning I woke up with a headache, that progressed into lack of appetite, fatigue; The following morning I woke up with a headache, that progressed into lack of appetite, fatigue, chills; The following morning I woke up with a headache, that progressed into lack of appetite, fatigue, chills, joint aches; I had a low grade fever in the evening on Sunday 4/18.; I became nauseous around 10pm on 4/17.; This is a spontaneous report from a non-contactable healthcare professional. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0169) via an unspecified route of administration on the right arm on 17Apr2021 at 08:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The medical history included asthma, COVID-19 and allergy to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously took azithromycin(ZITHROMAX) and experienced allergy. On 17Apr2021 at 22:00, the patient became nauseous. On 18Apr2021, the patient woke up in the morning with a headache, that progressed into lack of appetite, fatigue, chills, joint aches and in the evening the patient also had a low grade fever. The patient reported that she did not go to work on 19Apr2021 (Monday) due to lingering fatigue. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseous, headache, fatigue, chills, lack of appetite, joint aches and low grade fever was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection.  The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional.  On 12/10/03, the pt's attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths."  No further information regarding the specifics of their claims is available at this time.  It is unknown whether an autopsy was performed.
an expired dose was administered, no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00858482) and transmitted to Sanofi on 15-Nov-2021.  This case involves a 13-year-old male patient who received an expired dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) for Immunisation.  On 15-Nov-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (total, lot U6785AA, expiry date: 31-Oct-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  It was reported "caller would like information regarding re-vaccination."  At time of reporting, no adverse 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.
Arm soreness (could not move), shivering, fever, nausea, excessive sweating, neck stiffness, welts (not at injection site) all early the next morning after vaccine was administered.
From initial information received on 3/3/04 from the patient, regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received FLUZONE, lot number U1143AA, administered on 11/4/03. By 11/11/03, the patient developed polyuria and extreme thirst. Not recognizing these symptoms, the patient slowly lost 20-25 pounds before seeing a physician on 2/3/04. The physician diagnosed him as a diabetic and on 2/12/04 it was verified he has Type I Diabetes. He now requires insulin shots and continual blood glucose monitoring. This was the first flu shot that the patient ever received. He had no concurrent vaccinations, and he was not taking any medications at the time. He reports that he was not ill at the time of vaccination, or anytime near 11/4/03. The patient reportedly has not recovered from this event.
A nurse reported that a male received an injection of Pnu-Imune 23 on 01/16/01. Subsequently, he developed  "general" malaise and "severe" pain at the injection site. The reporter indicated that the patient is "feeling better" but his arm still remains sore.
Headache, dizziness, chills, weakness, muscle aches as well as injection site swelling and pain
red, painful, maculopapules, some vesicles b/l elbows x 3 days, this morning noticed them on b/l hands/palms, no fever, no URI
pt recv 2nd dose of vax on 06dec96; 17jan97 pt devel a 102 F fever, chills, sweats, & a localized, non-injections site pruritic rash on opposite arm in which pt recv vax;rash lasted a couple of days & flu-like sx have not yet resolved
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-JUN-2016, the patient was vaccinated with an expired dose of VARIVAX lot # K008820, expiration date: 19-JUN-2016 (dose, route of administration and anatomical location were not reported). Concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Near instant swelling and redness at injection with near inability to raise arm over shoulder level for 5 days, extremely loud ear-ringing both ears which is on-going in addition to pain and swelling in ear and jaw.  Immediate migraine triggered subsided with prescription and retriggered  with ongoing physical exhaustion.  Lower back pain for first 3 days which was not relieved with ibuprofen. Most bothersome symptom incessant ear-
Unusually sore arm after first dose. Recovered after 24 hours. Sore arm after second dose. Fever and extreme fatigue 24 hours after second dose. Recovered after 18 hours. Eye floaters - left eye, noticed after second dose. HAS NOT RESOLVED.
Vaccine given 11/16 at 9:15am. By 1pm, patient had cough and would eat ice.  3 hours later, patient's eyes burning, red and puffy.  Nasal airway swollen - "no air"; back of tongue swollen.  Patient has no known allergies. She took Benadryl 25mg three times that day and went to sleep.  The next day patient okay.
Few pimple - like lesions around immunization site (LAT) noted 1/29/03 by mom.
flu symptoms; a longer menstrual period, more than seven days and still ongoing; tired for 48 hours; immediately tasted metal " like licking a 9 bolt battery without the shock"; smelled weird things intermittently like electric burning for about 20 hours; sore arm (left); This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (immediately tasted metal " like licking a 9 bolt battery without the shock"), PAROSMIA (smelled weird things intermittently like electric burning for about 20 hours), PAIN IN EXTREMITY (sore arm (left)), INFLUENZA (flu symptoms) and MENSTRUAL DISORDER (a longer menstrual period, more than seven days and still ongoing) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cystitis (interstitial cystitis). Concomitant products included HYDROXYZINE for Cystitis, MELATONIN, VITAMIN K [VITAMIN K NOS], FISH OIL, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE]), VITAMIN D [VITAMIN D NOS] and DIAZEPAM (VALIUM) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DYSGEUSIA (immediately tasted metal " like licking a 9 bolt battery without the shock"), PAROSMIA (smelled weird things intermittently like electric burning for about 20 hours), PAIN IN EXTREMITY (sore arm (left)) and FATIGUE (tired for 48 hours). On 22-Mar-2021, the patient experienced INFLUENZA (flu symptoms) and MENSTRUAL DISORDER (a longer menstrual period, more than seven days and still ongoing). On 28-Feb-2021, DYSGEUSIA (immediately tasted metal " like licking a 9 bolt battery without the shock"), PAROSMIA (smelled weird things intermittently like electric burning for about 20 hours), PAIN IN EXTREMITY (sore arm (left)) and FATIGUE (tired for 48 hours) had resolved. At the time of the report, INFLUENZA (flu symptoms) and MENSTRUAL DISORDER (a longer menstrual period, more than seven days and still ongoing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-098194 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up was received on 29 April 2021.Newevents ( influenza and menstrual disorder) were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098194:Second case
Adminstration Error : COVID-19 vaccine (IM)  given ~ 1/2 inch from the top of the right shoulder in medial area.
Second dose of Moderna vaccine administered on day 22; A spontaneous reportwas received from a healthcare professional (medical director) concerning two patients, age and gender not provided, who received Moderna's COVID-19 Vaccine, and who experienced receiving the second dose vaccine on day 22 (Inappropriate schedule of product administration).    The patients' medical histories were not provided. Concomitant product use was not provided by the reporter.   The patients received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05-JAN-2021 (route of administration unknown). On 27-JAN-2021, the patients received their second of two planned doses of mRNA-1273 (Batch number not provided), route of administration unknown for prophylaxis of COVID-19 infection.  A medical directer reported that at one of his facilities, two employees received their first dose of the mRNA-1273 vaccine on 05-JAN-2021.  They were supposed to receive their second dose of mRNA-1273 the week of 01-FEB-2021 but got it instead on 27-JAN-2021 (day 22). The reporter questioned if the dose would be effective or would the patients need to be revaccinated.   Treatment information was not provided.    The patients received both doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The event, second dose of Moderna vaccine administered on day 22, was considered recovered/resolved; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event occurred when the second dose was administered 23 days after the first dose of mRNA-1273. Event resolved.
swelling on her tongue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: SWOLLEN TONGUE (non-serious), outcome "unknown", described as "swelling on her tongue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, swelling and pain at injection site. Chills. Narrative:  Per pt. report: "I received the second COVID-19 vaccination on 01/20/2021 on my left deltoid. On 01/21/2021, I started having headaches, chills, severe body aches and my left arm swelled like the size of a lime so, I had to leave work around 1000 AM on 01/21/2021. Symptoms lasted until the evening of 01/23/2021."
Information has been received from a physician, through the Pregnancy Registry for GARDASIL, concerning a 25 year old female who on 30-JAN-2008 was vaccinated with her first dose of GARDASIL (Lot # and route not reported). At the time of vaccination, the patient reported that she did not have her period for 3 months. A few days after her vaccination, the patient experienced spotting and went to the emergency room. A pregnancy test was administered and was positive (LMP approximately 05-Nov-2007). The patient was not admitted to the hospital. No further information is available. Additional information has been requested.
hives arms, chest, buttocks, mouth.  Mouth swelling.  treatment:  claritin 10 mg po.  symptoms resolved within 5 hours.  still some mouth swelling the following day, advised cetirizine 10 mg po daily X 3 days, famotidine 20 mg po daily x 3 days.
pressure headache; loss of appetite; slight runny nose; This is a spontaneous report from a contactable consumer, the patient. An elderly non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 12Apr2021 at 03:45 (age at vaccination unknown) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included verbascum thapsus leaf (MULLEIN) (reported as Mullein Leaf), acetylsalicylic acid (ASPIRIN), advanced D+K and Red Yi, all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced pressure headache, loss of appetite, slight runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events pressure headache, loss of appetite, slight runny nose was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
approx 48hr p/vax pt exp a localized rash @ inj site;pt was given hydrocortisone cream;pt also devel a rash p/ 2nd vax;no other details known as of the date of this report
Headache, Myalgia, Fever, CHILLS, LOWER BACK PAIN, FATIGUE Narrative:
Today, the patient returned to the clinic 3 days after injection. Yesterday mom noticed a mass under his skin/on top of muscle. No further symptoms.
Immun given @ approx 1130AM; TC from mom about 2 stating child shaking all over & hands turning blue; Referred to ER - temp 101, nasal dc; febrile sz ;BOM/URI; lung infiltrates; rx ceclor, rondec, tylenol;