chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt is a type 1 diabetic- increase in blood glucose above the norm despite insulin for a period of ~ 6hours; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 56 years on 26Jan2021 at a SINGLE DOSE for covid-19 immunisation .  Medical history included diabetes mellitus from an unknown date and unknown if ongoing type 1 diabetic. The patient's concomitant medications were not reported. The patient has a history of type 1 diabetes and had increase in blood glucose above the norm despite insulin for a period of 6hours on Jan2021. The patient underwent lab tests and procedures which included blood glucose: increase on Jan2021. No treatment was received for the event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately in November 2021 I began to feel strong heartbeats, even when I was sleeping peacefully I woke up flustered and suddenly with a fluttering heart. At certain moments I felt that my breathing was not adequate. Waking up suddenly became more frequent, so I decided to start going to doctors. In January I saw a doctor for the first time for this situation.
Silver dollar sized red mark at injection site with mild pain and on left arm pit. Pain lasted for about 5 days, red mark went away in about 3-4 days. No treatment.
Initial and follow up information has been received from a physician concerning a 65 year old female patient who on 26-JUN-2008 at 10:00 AM was vaccinated into the right deltoid with PNEUMOVAX (lot# 659487/1960U). It was unknown if there was any concomitant medication. The physician reported that the patient experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain occurred a few hours after administration and resolved within 24-48 hours later. It was unknown if medical attention was sought. No further information is available. Additional information is not expected.
pt had swelling & tenderness & a temp of 102;pt was taken to ER where recv inject per parent;
pt had a seizure 7 days p/vax was administered & has had them since;
Patient was vaccinated early Thursday afternoon. Sore arm, back aches, and body aches developed that night. Overnight high fever of 103.1 with body aches and chills. Patients wife called the Emergency Department early Friday morning reporting his fever and confusion. Tylenol recommended first and evaluation if no improvement. Tired and headache most of day Friday, some improvement in the evening but aches and chills again that night. Mostly recovered Sunday, no fever or aches.
Patient immediately felt dizzy, lightheaded, faint after received vaccine, also experienced nausea. Monitored for approx 1 hr until patient felt better/ "back to normal."  Vitals signs remained stable and SaO2 WNL throughout observation period.  Patient was transported in w/c from waiting area to observation bay and laid on gurney, bottle of water provided, snacks provided.  Pt remained A&O throughout observation period.  Husband present.
Large rash around injection site which over two days spread to entire upper arm.  Not painful but itchy at times.  I've had it three days so far.
A report was received from a health care professional on 10/24/2003 concerning a female vaccinee of approximately 75 years of age who experienced redness, swelling and pain at and below the injection site 3 hours after receiving Fluvirin on 10/23/2003. On 10/23/2003 the vaccinee experienced redness, swelling and pain at and below the injection site. The swelling was up to half size of an orange. The reporter was uncertain of the vaccinee's condition at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This is a spontaneous case reported by other non-health professional (consumer) and initially received on 12-Apr-2019, concerning a neonate male patient. The patient's mother had one previous pregnancy. The patient had no history of offspring with major congenital malformation neither had still birth or miscarriage. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother had no medical history. The patient's mother did not receive any concomitant medications. The patient's mother's last menstrual period (LMP) date was 19-May-2018. On an unspecified date, ultrasound was performed, and the baby's lungs were clear. On 04-Sep-2018, at 15 weeks gestation age, the patient was exposed to AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: transplacental, parent's route of administration: intramuscular, batch number and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for active immunization against influenza. On an unspecified date, 2 weeks after vaccination, the foetus was diagnosed with chylothorax (fluid around the lungs). It stayed consistent for many weeks but when the foetus was at 29 weeks gestational age, the volume increased so thoracentesis was performed to drain the fluid. The week before the patient delivered the infant, there was a little bit of fluid. 37 weeks and 4 days gestational period, the male infant was born. The delivery method was caesarean. Infant head circumference was 33 cm, infant body length was 19.5-inches, infant body weight was 7 lb 6 oz and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 10 at minute 5. The patient was born with hypospadias and when x-rayed after the birth, no fluid was found (recovery of chylothorax). The hypospadias was minor and depending upon the situation, six months later, surgery would be performed to resolve it. The patient's mother's estimated date of delivery (EDD) was reported as 23-Feb-2019. The patient had recovered from the event chylothorax and had not recovered from the event hypospadias. The reporter assessed the case as serious (medically significant). This case was linked to case: 201903028 (mother case).; Reporter's Comments: A male neonate patient was exposed to AFLURIA QUADRIVALENT vaccine (considered as foetal exposure during pregnancy) after maternal receipt at 15 weeks of gestation and was diagnosed with chylothorax in-utero, 2 weeks post vaccination which required thoracentesis. The patient was also diagnosed with hypospadias, at birth. Despite the plausible temporal relationship between vaccination and reported events, considering the lack of biological evidence with vaccination, the event chylothorax and hypospadias assessed as not related to suspect vaccine. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine.
On 2/26/2023, patient presented to the emergency department via ambulance from her assisted living facility for evaluation of weakness and a positive COVID-19 antigen test at her facility. In the emergency department, patient was given a COVID-19 NAA test which resulted positive; Her chest x-ray showed no acute cardiopulmonary findings; Her CMP and CBC labs were unremarkable, UA was negative, and EKG was normal sinus rhythm. Patient become hypoxic with ambulation and desaturated to 84% on room air; She was treated with oxygen supplementation and IV Decadron. She was diagnosed with hypoxia secondary to COVID-19 infection and weakness. Patient was admitted to the hospital for further evaluation and treatment. Hospital discharge date is unknown. At some point, the patient was transferred to where she died on 3/10/2023. Her death abstract listed immediate cause of death as respiratory failure due to COVID-19 infection.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
I am 19 weeks pregnant. My due date is March 16, 2024.  I threw up 7-8 hours after my vaccine, but not sure if that was due to the vaccine.  I suffered a nonstop headache from 8pm 10/21/23 through the early morning of 10/23/23.  My injection site is very sore especially if touched or grazed. On 10/23/23 my injection site swelled up and is visibly protruding red circle about 2-3 inches in diameter. On 10/24/23 it continues to be sore and now itches.
08/16/2005 Right arm redness, mild swelling.  Seen on 08/18/2005 - decreased redness and swelling.
Joint pain and stiffness in fingers, wrists, ankles, elbow, toes, and hips. No treatment as of yet, but symptoms not improving only worsening 12 days post COVID injection number 2.
With each Moderna COVID vaccine, dates of 1/21/2021, 2/18/2021, and 10/21/2021 the adverse events were similiar in the short term; COVID like symptoms, fatigue (requiring bed rest), nausea, headaches, muscle achiness, exacerbation of athsma requirign use of oral rescue inhaler, mild redness and soreness and itching at injection site, mild paryngeal and laryngeal edema, eustachian tube and oral cavity itchiness, overall skin itchiness which was mitigated by oral Benadryl.  "Allergic" reaction lasted 1-3 days each time but was managed/controlled by taking oral Benadryl.  After 1/21/2021 immunization,  3 days of bedrest needed (no work time missed due to work being virtual only).  After 2/18/2021- Sick symptoms  and bed rest lasted 5 days.  (No work missed due to work being virtual only.)  After 10/21/2021, Sick symptoms lasted 7-10 days, with 10/30/2021 being the first date of an inperson follow up doctor's appointment.  Post 10/21/2021, I had 5-6 cyclical bouts of fatigue/COVID like post vaccine  symptoms, each resulted in 3-10 days of feeling ill, several doctor's visits from 10/30/2021-present.  5/12/2022, fatigue became so bad I could not longer work.  I had 2 weeks of nearly complete bed rest during this time period, which got slightly better over time.  I have not been able to return to my previous job since.  Fatigue has lessened some.  Underlying cause still unkown.
Severe sciatic pain down my right leg. I have never had sciatica before. It has been going on for the past almost 4 weeks.
vaccines given post excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who experienced vaccines given post excursion with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad).  On 03-May-2022, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection at a dose of 0.5 ml (total) (lot C5916AA; expiry date: 06-Jul-2022) via intramuscular route in the left deltoid as Immunization.  On 03-May-2022, the vaccines were given post excursion with no reported adverse event (product storage error) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccines given post excursion with no reported 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 guidelines. 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.
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM,  completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
Since my second vaccine, I had irregular menstrual bleeding. At times this is light spotting, at times heavy spotting, I have gotten my period twice in 3-week cycles. I did finally seek an appointment with my FYN.
Intentional deviation from dosage regimen; horrendous flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (horrendous flu like symptoms) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (horrendous flu like symptoms). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (horrendous flu like symptoms) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) outcome was unknown.            No Concomitant medications and No Treatment medications were reported.  Patient would prefer to be contacted by her brother's email   This case was linked to MOD-2021-027485 (Patient Link).
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from October 2020 to December 2020. Concomitant products included AMIODARONE for Heart alternation, DIGOXIN for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included cholesterol medications and blood thinners. No treatment information was provided.
Patient was given a booster dose of Moderna.  After entering her dose into the state vaccine registry, we discovered she had gotten a Pfizer dose on 9/28/21 at a retail pharmacy.  Her COVID vaccine doses are as follows: Moderna 1/26/21, 2/23,21 & 11/4/21. all at a clinic/hospital location; Pfizer 9/28/21 at a retail pharmacy location.  The patient did not inform us that she had already gotten a booster dose of a different manufacture.  Educated staff to specifically screen for doses of different manufacturers on the state registry prior to giving a booster dose.
left arm red swelling with warmth, no itchness, no pain. Patient noticed the sx this morning (03/08/23)
This only occurred after the 3rd vaccine (booster). Went to the doctor for a regular physical and was told my platelet count was low after a routine blood test. She asked me if I noticed that I was bruising more easily or if cuts took longer to heal and I agreed, noticing those symptoms. Doctor ordered a second blood test to double check since it was done a few days after the injection, that it was be my body reacting normally to the booster. Second blood test came back the same. (A bruise developed where the needle went in and took over two weeks to heal) Doctor ordered me to wait about a week to retake a CBC test to check platelet levels again. Have yet to take that test because of a move out of state and no insurance until January 2022 due to that. As of 11/29/2021 a bruise is re-developing where the second blood test's needle went in, as well as feeling pulses in that same area and on the left-side of my head, above the ear, and around my left thigh.
Developed swelling and erythema at the injection site extending to the mid arm, full range of arm movements.
Patient presented to the ER on 8/20/21 for worsening shortness of breath and non-productive cough for the past week and half. Was found to be tachypneic requiring oxygen and tachycardic in the 130s. Admitted to the hospital for further work-up and evaluation.
developed leukocytosis following the vaccine in 02/2021, progressed to CMML-1
12-year-old female with past medical history significant for autism spectrum disorder, seizure disorder, ADHD on methylphenidate while in school who received first dose of Pfizer vaccine on 8/20/2021 and started on 8/24/2021 with chest pain.  Per mother she woke up on 8/24/2021 complaining of a mild retrosternal chest pain she otherwise felt well, mom thought it was muscular in origin so she gave Aleve and patient went to school.  On arrival from school pain was still there.  The following day the pain persisted but she still went to school when she arrived it was worse mom again gave Aleve and applied ice with some relief in the pain. On Thursday she still went to school but after she arrived the pain was worse so mom took her to ED. On arrival at outside hospital her temperature was 101.7 blood pressure 126/86 heart rate of 160 respiratory rate 22 and O2 sat 99% in room air Labs were significant for elevated troponin a mildly elevated proBNP, elevated D-dimer and an abnormal EKG with sinus tachycardia and minimal anterior T wave changes, chest x-ray was negative.  She received naproxen, Tylenol and normal saline bolus and she was transferred for further management.  In our ED she was afebrile continues to be tachycardic with heart rate between 101 120.  She was also tachypneic with respiratory rate between 20 and 32 O2 sat remained at 99 to 100% in room air.  Repeat troponin I of 1.17 (normal value up to 0.08), CK-MB at 8.1 and BNP of 100.  She was admitted and started on ibuprofen around-the-clock.  Since admission she has remained afebrile but continues to be tachycardic and tachypneic.  EKG on admission showed sinus tachycardia with anterolateral ST wave changes.  Echocardiogram showed no structural abnormalities, mild tricuspid regurgitation trivial to mild mitral regurgitation and normal biventricular systolic function.  No significant pericardial effusion.  Ejection fraction was 0.63.  Overnight she had worsening of the pain and required dose of IV Toradol.   8/29: Overnight, patient required one dose of IV Toradol last at 430pm when patient had peristent reproducible clavicular pain. Father mentioned that patient had prior L clavicular fracture, and patient tried to pick up older brother on day of admission. EKG obtained at time of persistent pain which showed sinus tachycardia. Remaining pain management tolerated with oral toradol and tylenol. XR of clavicle showed no evidence of fracture, and patient no evidence of COVID19 prior infection given IgG negative with RPP negative. Troponin and CKMB continue to improve with overall stable BNP (103).  Pain well controlled for over >12 hours will oral pain medications, so will discharge home with PO toradol and tylenol with follow up in 1 week. PCP updated on plan of care and will follow up with patient within a week. Instructed to hold methylphenidate.
Arm soreness; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and DIZZINESS (Light headed) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included CHOLESTYRAMINE and ADALIMUMAB (HUMIRA) for Ulcerative colitis, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), SERTRALINE HYDROCHLORIDE (ZOLOFT), CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]), VITAMIN D [VITAMIN D NOS] and MELATONIN for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and DIZZINESS (Light headed). On 04-Apr-2021, DIZZINESS (Light headed) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-163987 (Patient Link).