chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer as the first dose of COVID vaccine and then patient received Moderna as second dose. Patient did not experience any adverse reactions. Patient just experienced normal symptoms pertaining to immune response (nausea, headache, body aches)
Spiked fever of 102 F 20-25 minutes after vaccine. Complained of head hurting and moaning, become drowsy and fell asleep in arms for just 2-3 minutes and then woke up at 12:15 PM vomiting.  At 12:30 PM developed hives on right side of face and left leg (site of injection), trunk not visualized at the time. Hives resolved within 10 minutes. Received ibuprofen 100 mg chewable tablet. Refused to take diphenhydramine. Fell asleep at 2 pm and napped until 4 pm. At 5 pm spiked fever again to 101-102 F and complained of eyes hurting. Received ibuprofen again at 6:15 pm. Woke up at 3 am sweaty (temperature not recorded), went back to sleep without medicine. Woke up at 8 am (10/19/14) and no further episodes of fever.
Developed a red welt over injection site hours after, and awoke next day with severe pain in joints, requiring early dismissal from her work and assistance. Joint pain lasted 1 day and welt lasted 3 days.
Pt received second dose of moderna vaccine  as scheduled and complained of post immunization pain at injection site
SWOLLEN LYMPH NODES UNDERARM PAINFUL BURNING NEEDLE-LIKE SENSATIONS IN LEGS AND ARMS
transverse myelitis secondary to vaccine administration of the Moderna coronavirus vaccine at the on 4/15/2021
stroke at vision site; partial sight lost in left eye; feeling weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke at vision site) and BLINDNESS (partial sight lost in left eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Implantable cardioverter defibrillator insertion.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke at vision site) (seriousness criteria hospitalization and medically significant), BLINDNESS (partial sight lost in left eye) (seriousness criteria hospitalization, disability and medically significant) and ASTHENIA (feeling weak). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to BLINDNESS and CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke at vision site), BLINDNESS (partial sight lost in left eye) and ASTHENIA (feeling weak) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Computerised tomogram: (abnormal) Stroke at vision site. On 20-Apr-2021, Magnetic resonance imaging: (abnormal) Stroke at vision site.         No concomitant medication were reported.  The reporter stated that the patient was taking medicines but doctor changed her medication and she did not want to talk so she did not give names.; 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.
Patient was given the SHINGRIX vaccine (dose 1) on Thursday July 19th, 2018. She felt some flu-like symptoms for 48 hours, and on Saturday, July 21, she experienced a red-hot area below the injection site (below deltoid muscle). She noted the area was red and about 2x2 inch in size at 3am on Monday July 23. The area grew to a 3x4 inch size by Tuesday morning and was red, hot, and itchy. She compared the signs to that of cellulitis. She took a dose of Levaquin, and the area was less red but still hot by Tuesday night. She noted that the area was much improved by Wednesday morning but looks more like a bruised area. Until the dose of Levaquin, the area had grown from the bottom of her deltoid to her elbow and was covering about 3/4 around the arm.
He felt that she felt okay, like normal side effects; Caller knows there is a double dosing for an immune compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Dementia.    On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised). At the time of the report, IMMUNISATION REACTION (He felt that she felt okay, like normal side effects) and EXTRA DOSE ADMINISTERED (Caller knows there is a double dosing for an immune compromised) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had normal side effects. There was a double dosing for an immune compromised. Patient was not immune compromised but in the late 80's or early 90's age.
Complete dose of Zostavax was not given to patient, part of the dose leaked while administering to patient.  Pt was revaccinated again within a couple of hours.
Patient reports chills, pain in the left arm (no site reaction, redness or swelling, no loss in mobility), fatigue.
Information has been received from a male reporter concerning a 14-month-old male with no pre-existing allergies, birth defects, or medical conditions who on 26-JUN-2007 was vaccinated with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 657265/0293U).  Concomitant therapy included TRIHIBIT (lot# UFUOAA) and a first dose of Vaqta (MSD) (lot# 656993/0001U).  There was no illness at the time of vaccination.  On 05-JUL-2007 the patient experienced a measles-like rash that began behind his ears and progressed to neck then face, arms, back and legs.  The patient sought medical attention, he saw a physician who gave a visual diagnosis.  No outcome was reported.  Additional information has been requested.
pt exp erythema, induration, inflammation, & swelling @ the inject site p/vax;
PT FELT FEVERISH IN THE DURING THE DAY OF 11-11-22. SHE TOOK TYLENOL NIGHT BEFORE AND MORNING OF THE 11-11-22. SHE HAD DIARRHEA 4-5 TIMES ON DAY OF 11-11-22. SHE CALLED HER DOCTOR TO SEE IF THIS WAS SIDE EFFECT OF SHINGREX. PROVIDER SAID TO  CALL PHARMACY. PT WAS TRYING TO RULE OUT FLU . I TOLD PT THAT DIARRHEA IS A REPORTED SIDE EFFECT.
This case was reported by a consumer and described the occurrence of vaccination failure in a 12-year-old female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. In January 2018, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional information was provided as follows: The age at vaccination was not reported. On 18th January 2018, the reporter became aware of the patient who had received 2017-18 seasonal influenza vaccine (manufacturer unknown) at an unknown date before 2018 and was diagnosed with influenza. The patient was confirmed by positive flu test administered in the physician office. The reporter did not have the physician contact information and the patient's parent refused to provide additional details or permission to contact for further follow up. This case was considered as suspected vaccination failure as the time to onset for influenza was not provide at the time of reporting.
Hives on Left shoulder close to site of injection. She states she started feeling pain on left shoulder last night (8/27/19) and couldn't sleep because of the pain. 08/28/19 Patient given triamcinolone (Kenalog) 40mg
Patient presented to clinic to receive 1st dose of COVID vaccine. Vaccine order has been placed per standing order. Consent form signed, COVID vaccine card, EUA Fact Sheet, and reporting information given. Patient tolerated injection well.  Immediately after receiving the vaccine, patient reported feeling dizzy, numbness and tingling in her lips and tongue, nausea, headache, slight difficulty breathing, and hot flashes. Notified provider of side effects. 50 mg Benadryl ordered and 4 mg Zofran. 10 minuets after benadryl administration patient reports breathing difficulties, numbness and tingling in lips and tongue, and hot flashes have improved. Still reports headache and nausea.  Patient to be monitored for 30 minuets from Benadryl administration.  RN stayed in the room with patient during waiting time. Patient talking, alert and oriented. No outward signs of distress. Injection site painful when touching only with some slight swelling. Patient asking for Diet coke for headache and hot flash. Reports feeling almost back to normal, still has headache, some hot flashes and nausea.  Provider came in to check on patient before discharge. Checked mouth and throat and listened to lungs.  Time spent with patient related to COVID vaccination: 50 minuets
Pain right shoulder, swollen right hand fingers, headaches, numbness in the forearm, pain edema, rubor.
Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, muscle soreness.
Had the shot on 10/1, began loosing ability to lift right arm, by 10/14 went to Bone and Joint and they examined by shoulder with an MRI, there was nothing wrong with shoulder, so they sent me to have an EMG, that showed my C5-C7 was damaged.  So then they sent me to have an MRI of my neck, Then I saw another Doctor who wanted to cut me open and put in artificial discs.  So I got a second opinion from Dr who has sent me to a Neurologist, but I can't get in until 1/25/2022.  I'm concerned that I should see someone sooner and want to know if you have had any reactions like this. My son at age 10 was hospitalized for Guillan Barre and don't know if that has anything to do with my DNA.  I'm really looking for some type of direction from the CDC.  Along with not being able to lift my right arm, I have a hard time swallowing and my voice has changed slower and horse.
Diarrhea and chills 27 hours after injection.  Felt slightly ill.  Diarrhea lasted until the following morning, then I was fine.
Generally unwell; Fever; sever body aches; injection site Pain; Chills; lymph node swelling on side of injection; This is a spontaneous report from a non-contactable consumer.   A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 33) single dose arm left on 04Feb2021 10:30 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of BNT162B2 right arm on 14Jan2021 03:00PM. No other vaccine was received in four weeks.  The patient experienced generally unwell, fever, sever body aches, injection site pain, chills, lymph node swelling on side of injection, all on 05Feb2021 12:00. The events outcome was not recovered.  No follow-up attempts are possible. No further information is expected
I almost died; Allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I almost died"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Allergic reaction". Clinical Course: Patient dont trust the vaccine. She almost died from an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two hours after vaccination - very sick, nausea + flu like symptoms for 30 hours (in bed)  I had to pay $163.09 out of pocket because my insurance would not cover SHiNGRiX shot. I am suppose to have another shot and another $163.09 for the follow-up shot. I am afraid to do it. I have insurance. Not happy.
The patient was vaccinated on a Friday afternoon and noticed the reaction Saturday evening on the inside of her left arm.  t was presented to me on Sunday afternoon. There was a red blotch. The patient said it had been darker but was not causing her any pain, discomfort, itching, etc. I told her BENADRYL could be taken as well as icing the area. I advised her to seek medical care immediately if the area began to swell past a major joint such as the shoulder or elbow. I advised her to monitor the area but to see a physician if the area had not improved by Tuesday.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 02-AUG-2016 (reported as 'yesterday') the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # reported as M005972, expiry date 02-FEB-2018 (dose, route of administration and anatomical location were not specified). The administered dose of VARIVAX underwent temperature excursion at 26 Fahrenheit degrees for 6 hours. No previous temperature excursion was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This is a prospective pregnancy case. This 37-year-old female subject was enrolled in an open label study. The subject received Flu Seasonal QIV Dresden (intramuscular) on 17th October 2016. Concurrent medical conditions included head cold. Concomitant products included DELSYM, Prenatal Vitamins and TYLENOL. The subject's estimated date of delivery was 10th June 2017. The subject received Flu Seasonal QIV Dresden at week 6 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The case was previously reported to doctor. At the time of the vaccination, the patient noted that she had a sinus cold. She had this cold for several days prior to this vaccination. This was not related to the vaccination. The patient received FLUARIX QUADRIVALENT in her left deltoid. The batch number reported for FLUARIX QUADRIVALENT was 3CG9P with an expiry date as 22nd June 2017. The date of last menstrual period was not reported. Follow up information was received from consumer on 30th November 2016: This case was upgraded to serious due to an event miscarriage (serious criteria: GSK medically significant). The patient's last date of menstrual period was reported as 2nd September 2016. The patient gave consent to contact her healthcare provider for medical records dated between 2nd September 2016 to 2nd September 2017 and provided contact details for the same. According to ultrasound done on 8th November 2016, the miscarriage occurred at 6 weeks and 3 days of gestation (same day of vaccination). According to the ultrasound scan done on 14th November 2016, the patient had a miscarriage at 5 weeks and 5 days of gestation.
Not feeling well, his head was "heavy", felling hot and her photo phobia (not tolerate the light).
the patient was inadvertently administered a dose of MMR II which expired on 6/2/2018; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 23-SEP-2020, the patient was inadvertently a dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (strength and route of administration not reported; lot # M027637 and expiration date 02-JUN-2018) for prophylaxis (expired product administered). No adverse effects were reported.
strong groin pain made it difficult to stand erect.  pain is still present today although  not as severe.
Redness from injection site to elbow on (R) arm reported by mother. Resolved next day. No other symptoms.
pt recvd vax & exp heat related injuries during physical therapy run; became light headed & devel a rectal t of 104.9;
Rash, ErythemaMultiform, Rash developed at the injection site after 8 days of receiving first dose of vaccine. She used topical analgesic and Benadryl po with good results.
Covid vaccine left arm Swollen from time of Vaccine 3/22/2021 through current date 4/5/2021
On 10/22/2022, about 06:00PM, I started experiencing increased pain in my joints. I had pain in both wrists, both arms, both hands, both knees, all fingers, ankles and the balls of both my feet. It was a Rheumatoid Arthritis Bilateral Flare. I took my medications and moved and soaked in EPSOM salts. My pain level stayed at an 8. On 11/02/2022, my pain level hit a 10. I went to the emergency room. They gave me TORADOL and morphine. I was discharged at 03:30AM and it was recommended that I see my Rheumatologist immediately. At 09:00AM I was in my Rheumatologist's office. They gave me 1000 mg infusion of steroids through an IV. I was ok until 11/05/2022, and then the pain returned. I am still having issues. I will see my Rheumatologist on Monday.
severe arm pain not just focal injection site but entire upper arm to elbow that persists at 5 days post vaccine.  6 hours after vaccine dizziness that persisted for 36 hours.  Myalgias, diffuse and severe within 12 hours of vaccine lasted 36 hours Treatment with Motrin.  Arm pain and dizziness occurred with first dose as well but were milder and shorter in duration.  Severe myalgias only with second dose and self-limiting.
Varicella - Information has been received from a woman from a physician's office concerning a 9 mother old caucasian female who on 08 Apr 1995 was vaccinated with one dose of varicella virus vaccine live.  On 13 Apr 2000 the patient experienced chickenpox.  There were approximately 30 pox.  some were crusted over.
Pt was vaccinated to the right deltoid with the Pfizer vaccine at 1150.  At approx. 1208 she began feeling a little dizzy. She had no other complaints. No SOB, No rash, No nausea, No blurred or double vision. Her skins were warm and dry with good color.  She has no medical hx. No medications. She is allergic to Iodine.  Her initial vitals at 1211 were 132/84, 77 and 99%. At 1218 they were 140/88, 76, 99%. She drank some water and started feeling a bit better.  She only drank a cup of coffee with a muffin this morning. At 1228 her BP was 134/82, 74, and 99%.  She drank more water and said she felt even better.  She refused 911 to be called for any further evaluation.  She was advised to call 911 if any further symptoms developed after leaving the facility.  Her husband was driving her home and she was advised to eat lunch.  She signed our paperwork after being advised of the situation and what had been documented.
RECEIVED LESS THAN 0.5 ML OF THE JANSSEN  COVID-19 VACCINE AS A INITIAL DOSE (0.3 ML); This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5 ml of the janssen covid-19 vaccine as a initial dose (0.3 ml). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5 ml of the janssen covid-19 vaccine as a initial dose (0.3 ml) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211210019, 20211210058, 20211209976, 20211209921, 20211210160, 20211210610, 20211210733 and 20211210409.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 50-year-old female patient 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 10-May-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Rash on stomach, tingling on fingertips, itching on feet and palms, swelling on ankles
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 03-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX), on 22-SEP-2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and would continue to require healthcare and services. The patient had incurred and would continue to incur medical and related expenses. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability and medically significant.