chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A female patient (age not reported) received ADACEL, FLUZONE and MENACTRA (lot numbers not reported) on 11 February 2009 in the afternoon. That evening, at approximately 23:00 hours, she noted some blurred vision. The following morning her vision was very blurred, so she contacted her physician who prescribed over-the-counter VISINE eye drops. The patient also noted chills, aches, cough and mild shortness of breath following the vaccinations, which she reported was typical for her. The patient fully recovered within 24 hours. Additional events for this same patient are recorded in case 2009-05361. Documents held by sender: None.
Patient stated that 72 hours after receiving the updated booster, she experienced crushing fatigue, sore throat, and hives appeared on her back. Even on 09/23, she stated she still felt the fatigue although the headache has subsided.
9 days after shot, developed a quarter-size pink spot at injection site, which was warm to touch and itched slightly for a day. The pink spot faded away 4 days later.
Itchy eyes, runny nose, watery eyes. Gave ALLEGRA.  Okay 1/22/10
bump at the injection site it was about 1 inch in diameter; Red ring; large Blotchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site). At the time of the report, INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  No Treatments were reported.
Due to my prev positive covid infection on 4/25/20 I've had lasting issues & dealth w long covid. Dx with neurocardiogenic syncope, migrainosous, MECFS, Idiopathic hypersomnia and severe memory and processing deficits (neuropsych eval performed). Was prescribed alzheimer's medication for my memory issues, monthly injections for my migraines and vyvanse for my idiopathic hypersomnia & adhd. A few hours after my injection I started feeling really "out of it". Lots of trouble with memory, lapses in time, forgetting, difficulty focusing- all of this has lasted for over a week & only slightly & slowly getting better. Feels like the booster nulified all of my medications and that they have no effect when i take them.
On 2/1/06 seen in PMD office for 2 week history cough, headache X 1 day and c/o not being able to feel legs and arms X 8 hours. On 2/1 exam normal except for decrease ability to diserimate sharp/dull. 2/2 Admitted to hospital fever and decreased strength lower extremities. Diagnosed with ADEM. Symptoms resolved after 36 hours - No treatment.
CHILD PRESENTED WITH GRANDFATHER FOR SWELLING OF ARM WHERE VACCINES WERE GIVEN THE DAY BEFORE.  REDNESS AND WARMTH TO THE AREA OF THE RIGHT DELTOID MUSCLE,  ABOUT 50MM IN DIAMETER WITH LOCALIZED SWELLING TO THE SAME AREA. SKIN UNAFFECTED TO THE SUBCUTANEOUS AREA WHERE THE PROQUAD WAS GIVEN.  NO FEVER PRESENT.  CHILD COMPLAINS OF SORENESS TO THE ARM BUT IS CHILD'S DEMENOUR AND ACTIVITY LEVEL UNAFFECTED.   VACCINES WERE STATE SUPPLIED VACCINES
Pt c/o tachycardia, v/s taken HR = 108 Reg, BP= 110/80 @ L arm. BP checked again after 15 mins 120/80. Resolved after 15mins. States relief and d/c in no distress. Advised to notify PCP or go to ED any problems arises.  Did not have any recurring or residual effects after tachycardia resolved.
Muscle soreness, did not think it was linked to COVID but rather fibromyalgia -> had a CDC VAERS check-in the same week as my employer prompting me to get COVID tested at our worksite -> negative COVID test + no other COVID symptoms
On 02/20/2016 child noticed a rash on chest, back, and thighs. Rash is not raised or itch per mother and no fever or other symptoms reported. Mother administered Benadryl. As of 02/22/2016 rash has not resolved.
Pt recv vax on 12/29/98; on 12/31/98 pt exp seizures & fever
pt seen by MD 15OCT92 because was not drinking as well as previous to vax was also some that fretful; 16OCT92 to have rash checked; poss viral problem not realted to vax;
p/ pt recv vax approx 12 later pt exp 5 lesions. addl info requested
When I woke up, I thought the shot gave me covid. I woke at 2 am and I had a temperature (101 forehead), but I was very cold. I vomited 3 times in a three-day period, and I had a headache was very weak I could hardly turn over in bed. The arm I got my shot in was seriously sore. My arm was burning and swollen and very itchy. I took Tylenol and it helped some but not totally.  Later that evening the started to go away I was no longer weak as well. By the third day it was like magic the pain was completely gone within mins of feeling the pain. Although I had these issues, I never got short of breath, runny nose, sore throat.
expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vial was kept in Refrigerator on 06 December 2021.
Chills muscle pain  Headache  Nausea Sore throat  Tylenol protonix
Raised patches of rash/hives sporadically on both of child's legs. No itching. Constant screaming all day. Rash disappeared by end of same day. Rash returned 08/31/2010 for a few hours. Rashed returned 09/01/10 for a few hours.
allergy like symptoms; She states she has very mild symptoms that she mistaken for a weak cold; Tested positive for covid; Tested positive for covid; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested positive for covid"; HYPERSENSITIVITY (non-serious) with onset 06Jan2022, outcome "unknown", described as "allergy like symptoms"; NASOPHARYNGITIS (non-serious) with onset Jan2022, outcome "unknown", described as "She states she has very mild symptoms that she mistaken for a weak cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: Tested positive for covid.  Clinical course: 'Patient was healthy'. It was also stated that event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: numbness in fingers on right hand, started before injection-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient reported numbness after vaccine, when asked when it started she said before she got the vaccine but got worse after.  She denied any other side effects and was not showing any signs of allergic reaction. She said she was nervous & not sure if her tension impacted sx. Recommended she follow up with her MD if symptoms got worse or did not resolve
RESISTANT SEIZURE REQUIRING MIDAZOLAM DRIP, PHENOBARB, LORAZEPAM TO CONTROL
This spontaneous report was received from a 24 year old female patient. The patient's pertinent medical history included asthma. she was allergic to latex. On 02-DEC-2016, the patient was vaccinated with PNEUMOVAX23, via intramuscular route, in her non-dominant arm, for prevention of pneumonia (strength, dosing details, anatomical location, lot# and expiration date were unknown) and was also vaccinated with influenza virus rha 3v vaccine (baculovirus)(FLUBLOK) at the same time, in the same arm (medication error). Concomitant therapies included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), Montelukast sodium and Progesterone. On 03-DEC-2016, she waked in the middle of the night  experiencing fever, chills, weakness, nausea, loss of appetite and headache. She also stated that the injection sight is rashy, swollen and the pain is extreme. The patient sought medical attention and received treatment for the adverse event. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved.  Additional information has been requested.
red hives on face, arms, legs & hands; itchy felt feverish; pain @ inj site; sx subsiding later that same day; APAP given;
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted within 15 minutes of receiving first dose of pfizer covid vaccine. patient immediately gained conciousness
Patient complains of pain at the injection site which has lasted for eight months and is not yet resolved.
Client, age 14 years old, received a 3rd (booster) dose of Pfizer vaccine.  No adverse event reported at the time of the injection.  Attempted to call mother of child (who also received a 3rd (booster) doe of Pfizer vaccine, but no response.  The vaccine was administered at a 'Pop-Up' clinic.
Pain and tingling in legs mostly. Sometimes pain in my arms and hands as  well.  Started as pain in both legs followed by numbness and then twitching started in both legs.  Visible twitching.  Malaise, general feeling of being sick.
very acute confusion; marked confusion; never had it before; completely out of character; This is a spontaneous report from a contactable Nurse (patients daughter). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 14:30 PM (at the age of 91-year-old)  as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), in Jan2021 for COVID-19 immunization and experienced minor soreness and nausea; the Flu vaccine and experienced aches, chills, fever, and once even had a red streak up and down the injection site arm. On 05Feb2021, immediately after received the second shot, the patient experienced very acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character. The nurse informed that her mother had never had marked confusion before and since it did pass, the nurse feels it's medically significant. It was reported that the patient was observed for 15 minutes and then got up and went back to her apartment. In that period of time when in there, no one noticed what happened in that few minutes. The nurse reported her mother's neighbor was who called her. The nurse was on the way to pick up her mother anyway because she knew there was always a chance of side effects with older people. The nurse had just driven up within that 15 minutes when the neighbor called stating the patient was confused. This was completely out of character for her. When she picked up her mother she took her to the emergency room which is maybe 20 minutes away and didn't have the petal to the metal. On the way to emergency room could see her mother starting to clear up. She had her down in the car in about 10 minutes, 20 minutes driving to emergency room, so a total of 45 minutes to hour. They asked questions and within the hour her mother was okay, it was scary. The clinical outcome of very acute confusion and completely out of character was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events "acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character" with BNT162b2 can not be completely exclucded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
very sick; coughing/cough is uncomfortable/minor cough; sweating; fever; chills; body ache; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). The patient was treated with AZITHROMYCIN DIHYDRATE (ZIPACK) at a dose of 1 dosage form and PREDNISOLONE at a dose of 5 mg. At the time of the report, ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided Patient stated that she doing gargle of salt water. lung breathing test and everything is fine
got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Type 1 diabetes mellitus (no dates provided), Drug allergy (Azithromycin) and Infertility NOS (Could not get pregnant right away.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, IRON DEXTRAN (IRON [IRON DEXTRAN]) for Vitamin supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 12-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2020, Pregnancy test: positive (Positive) Positive. On 23-Sep-2020, Ultrasound scan: normal (normal) normal. On 23-Oct-2020, Ultrasound scan: normal (normal) normal. On 30-Oct-2020, Ultrasound scan: normal (normal) normal. On 23-Dec-2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient previous pregnancy details -delivered live full term baby . Treatment details was not reported by the reporter.  This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a physician and described a 21-year-old female subject who did not respond to immunization with Engerix B for prophylaxis.  The subject received her first, second, and third dose of Engerix B on 29 September 1999, 29 October 1999, and 12 April 2000 respectively.  On 23 February 2007, approximately 7 years after her third vaccination with Engerix B, random titer results which included hepatitis B surface antibody titer were negative.  Follow-up was received from reporting physician on 09 April 2007.  The subject was reported to be in good health.  The subject's diagnosis was reported as "no detectable titer on 23 March 2007".  The lot number of Engerix B was reported as 3075A2 0098 SKB.  The physician considered the event was related to vaccination with Engerix B.  He indicated the event was not serious, but considered that it jeopardized the subject or required intervention.  The immunization series with Engerix B was not discontinued or delayed.  At the time of reporting, the event was unresolved.
Nausea, extreme fatigue, joint pain, bone pain, headache, muscle pain, brain fog, dizziness, liver levels elevated, anemia, extreme leg & wrist pain.  No treatment given. Blood tested given to rule out many things.  Liver levels returned to normal after around 8 weeks. Anemia still an issue. Pain in wrists still very  bad and often upper thigh leg pain.
lump 2" @ inj site, diffuse redness around site x 2 days;
Chills, Fever, Headache, Joint Pain, Body Aches, Tiredness, Some Nausea
Having rashes on lelf and right hands , lelf and right legs/tight/hips areas . After 2 weeks of my full vaccined i have only a couple of rashes.. and on and on.. addition 2-3, and adding more more everyday.. I More..more until I decided to go to see doctor for medicines. My doctors gave me 2 kinds of medicines: Hydroxyzine 25MG /30 pils  and Prednisone 20MG/20 pils .. He didn?t give me a refill.. I have to make appointments zoom with him after my medication is out.
Right leg red and warm; rash measured 8cm by 5.5cm. Left thigh pale papules; no temp.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 04-FEB-2014 the patient was vaccinated with a dose of MMR II (injection, therapy type, lot#, dose, route were unspecified) that expired on 30-JAN-2014. No adverse effects were reported. The outcome was unknown. This is one of the three reports that received from the same source. Additional information has been requested.
My newborn was given the vaccine the day we left the hospital (she was 2 days of age)...she left the hospital screaming. That night she screamed...the next night the seizures began, nightly until she was admitted to the NICU at age 6 days. I did not know they were seizures until I asked pediatrician about the convulsions at her 5 day checkup, she told me what to look for and this was confirmed the following morning at which point she went to ER, then to NICU and was there for 6 days. 3/9/06 Received Discharge Summary which revealed patient experienced seizures & agnormal labs.  Positive family hx for seizures/ss
After the vaccine 12 hours I did have a splitting headache and I also had some lymph node pain under my left arm. Headaches lasted 12 hours and after some Tylenol headache went away. Lymph node pain stayed for a few days.   05/09/2022 Slight sore throat and congestion my first day of having Covid-19. Second night post nasal drip and extremely sore throat no fever. I also got tested for Covid-19 on the May 10th 2022 that came back positive. I went to urgent care and was given a prescription for the cough, Benzonatate, was directed to take Flonase. Lingering congestion sticking around.
pt recvd booster dose MMR vax 13MAR91 & 20MAR91 devel a fever; 3 days later pt seen for fever & cough; found to have pharyngitis; 25MAR91 seen again w/rash, eyes were red & swollen; pos Koplik's spots, mac pap rash & erythema; dx measles;
About 12 hours after injection, pt. began to feel chills, malaise, and myalgia. Approximately 24 hours after symptoms began, pt. stopped feeling symptoms. No body temperature was taken. Pt. took 1000mg of acetaminophen one time.
inconsolable crying for 5-6hr, rt leg swollen & red for 3wk;
This spontaneous report as received from a other refers to a 33 year old male patient with colitis ulcerative. On 22-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105, intramuscular for prophylaxis. On 22-AUG-2017, 1 day after onset of therapy, the patient experienced injection site erythema, injected limb mobility decreased, skin warm, injection site warmth and injection site swelling. The outcome of skin warm, injection site warmth, injection site swelling, injection site erythema and injected limb mobility decreased was reported as recovering/resolving.       Additional information has been requested.; Sender's Comments: US-009507513-1708USA013357:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion five time. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were as following: the first excursion was 128,22 and R; the second excursion was 112, 32 and R; the third excursion was 344, 31 and R; the fourth excursion was 264, 30 and R; the fifth excursion was 256, 29 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
erythema, swelling, pain, pruritus, induration 7x10cm lt deltoid;no resp compromise/afeb;weight 44lbs;
Injection site redness/swelling/pain along with systemic fever, headache, neck pain.