chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated temperature (99.5°F was the highest); irritated sinus; intermediate nausea; congestion; coughing; Is not feeling good ever since getting the vaccine; Wakes up feeling fine, but during the day feels worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion) and COUGH (coughing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse). At the time of the report, PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included flonaze. Concomitant medication also included medications for High blood pressure.
ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Patient's wife stated that the patient had a temperature of 103 and his arm that he has recieved his Pneumonia shot and Flu shot in was red and swollen and felt hard.  Told her to call his primary care physician and take him to be seen as soon as possible.
The day after my vaccine I was congested for about two days and then late on the second day I had a couple dizzy spells. On the third day when I woke up, I was having trouble breathing and my heart felt restricted. As the day went on, it got so bad that I felt faint and people said I looked pale. I called the ambulance at my work and they brought me to the ER. On the way there they gave me oxygen and gave me aspirin. The following morning I saw a cardiovascular DR. She said everything looked fine and I followed up with my primary DR. My PCD said it was definitely a reaction to the vaccine that I got and advised me not to get the second dose.
Large red circle around site reported 9-7-07. It was the Menactra site. It lasted a week and went away without Rx. It appeared the day after the shot.
had some pain in left arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had some pain in left arm where the vaccine was administered on Feb2021. Caller just got the 1st dose vaccine the day before this report and had some pain in left arm where the vaccine was administered. Caller asked if he could take 81mg Aspirin and use hot rubs that have methanol content. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Blistery rash on left forearm that is painful. Pt was diagnosed with shingles at ER and was started on an antiviral.
Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 4:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 4:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
Unk if caused from DT; pt admited to hosp 8 days p/inject w/septic arthritis lt shoulder;
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a child patient (age and gender was not reported) who was vaccinated only with diluted part of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) and not the liquid component, no AE on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique and product use issue (it was reported that the caller had given the diluted part of the vaccination and not the liquid component). No further information was provided. No information about adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Day 1, tired & achy     Day 2 - 14  hard to concentrate, arm sorness, feeling of inflamation in whole right arm up to and including fingers and back and front of shoulder.        Day 9 - Hard, inflammed, red cirle at vaccination site which then turned into a raised outter circle which got slightly bigger. It then by day 14 (today) it is a flat circular pattern around vaccination site, arm feels VERY sore and achy. Starting to feel more alert, less tired.
22 yo female without pmh, presented to USC vaccine site for 2nd dose of Moderna covid vaccine today. She arrived with boyfriend feeling well. Shortly after administration of vaccine, pt felt lightheaded and nauseated and passed out. Syncope was witnessed by medical staff. Pt was sitting in chair at the time and lowered carefully to the ground in supine position with legs elevated. She  responded to name and sternal rub within seconds.  Now feels sleepy. Denies SOB, CP, HA, numbness/tingling, pruritus or rash, abd pain. Nausea improving. No hx of syncopal reaction to vaccines or other. Denies being pregnant, not on menses. No meds pta. Vitals BP 110/70, HR 59bpm, RR 14, SpO2 100% ra, no thermometer available Heart and lung sounds normal, oropharynx benign, abd non-tender, no obvious rash or swelling or angioedema. No signs of anaphylaxis. Appears vasovagal. Within minutes, pt improving, skin color returning to normal. Able to respond verbally with understanding. A&Ox4. Sxs improved. Monitored full 30 minutes. Able to go home  with boyfriend, educated on precautions, recommended rest and hydration.
Redness, heat and swelling around injections site measuring 4in x3in in diameter. Tender to touch.
Pt reporting localized rash to anterior forehead, right temple, and bilateral cheeks. Pt assessed without any s/s of systemic spread of rash. Pt denies itching, but reports burning at rash sites. Pt offered PO Benadryl, but refused d/t lack of ride home and approximately one hour drive. Denies SOB, no wheezing, no reports of tongue or throat swelling. Pt reports she has benadryl at home and will take when she arrives home. VS at 1030: BP 124/94, HR 81, RR 16, O2 sat 99% on RA. VS at 1040: BP 127/84, HR 80, RR 17, O2 sat 99% on RA. VSS at time of d/c to home. No s/s of distress noted. Pt refused wheelchair to exit, opting to ambulate instead, escorted by staff.
Employee reported a bloody nose and blood in urine this morning (slight tinge) Has not exhibited any other side effects at the time of this report. Noted in afternoon on 12/18/2020 urinated and no blood present.
He was lightheaded, his upper body became very sore and achey, he was unable to sleep all night yet was fatigued. I gave him homeopathic remedies, probiotics, detox baths, liver, lung and kidney herbal support, pine essential oil topically. He is participating in athletic activities and seems to have avoided anything long-term, I hope.
Really bad seizure; A spontaneous report was received from a physician  concerning a 31 year old female patient  who received   Moderna's  Covid 19 vaccine(mRNA1273) who developed unusual seizure.  The patient's medical history as provided by the reporter included 215Q- 2 copies of a piece of chromosome 15 and the patient was on medications for seizure, sleep disorder and urinary incontinence. Products known to have been used by the patient, within two weeks prior to the event, included daprica, Trazodone, Oxybutynin and Carnitine.   On 18-FEB-2021 approximately eight days prior to the onset of symptoms the patient received first of two planned dose of mRNA-1273 (Batch Number 024M20A) for prophylaxis of Covid 19 infection.  On25 -FEB-2021 patient had a really bad seizures without the usual triggers. The pulse rate of patient was 89 and came back up.The event was considered as medically significant. The treatment for the event include Valium 5mg.  Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event  really bad seizure was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Muscle pain initially within expected levels, but increased over a course of days to severe levels. Unable to raise my right arm over my head, arm strength has decreased by about 30 percent. Pain level has decreased over the last 24 hours but it is still at Level 7 out of 10.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. Concurrent medical conditions included nonspecific reaction (the patient had some symptoms before vaccination). On 11th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and unsteadiness. In December 2018, the patient experienced pain in arm (serious criteria other: serious as per reporter), chills, increased urinary frequency, painful respiration, burning in throat and erythema of extremities. On an unknown date, the patient experienced condition aggravated. The patient was treated with BENADRYL. On an unknown date, the outcome of the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head and erythema of extremities were recovered/resolved and the outcome of the unsteadiness and condition aggravated were unknown. It was unknown if the reporter considered the pain in arm, chills, increased urinary frequency, painful respiration, burning in throat, weakness, neck tightness, ear feels clogged, eyes heavy feeling of, heaviness of head, erythema of extremities, unsteadiness and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Less than a day, after receiving SHINGRIX, at same night she experienced pain in the same arm (left) in which she received the injection. The pain lasted for a few days. Less than a day, after receiving SHINGRIX, at the same night she also experienced an increase in urinary frequency, going to the bathroom 4 times during the night and also stated that her breathing felt uncomfortable. Less than week after receiving SHINGRIX, her throat felt like it was burning and her left arm was a little red as well. She also experienced chills. When she woke up the next day, she felt wobbly and weak, her neck was tight, ears were stuffy and her eyes felt weighted. She also felt like there was 20 lbs of weight on her head. The patient took a BENADRYL and that it helped a little bit, but did not help much. She felt like she had some of these symptoms prior to receiving the vaccine, however, she felt like these symptoms were intensified after receiving the vaccine. The reporter did not consent to follow-up. The reported stated that my issue was not resolved, I still had to see a doctor. Your representative could not give me answers to everything having to do with side effects, serious side effects. So, I would see my doctor as soon as possible.
Hospitalized with blood clots in his lungs and a-fib; Hospitalized with blood clots in his lungs and a-fib; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included covid-19 prior vaccination: Yes. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. On 22Mar2021 at 10:00 (reported as 3 weeks after the his second shot), the patient was hospitalized with blood clots in his lungs and a-fib. The patient was currently in the hospital. The patient was treated with oxygen and anticoagulant. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
I woke up early in the morning day after the vaccine with extreme dizziness, ataxia and nausea. Mild headache.
States injection site sore after injection on 12/2/02. Reports noticed swelling on 12/4/02. Site warm to touch. Presented to PMD 12/5/02-treatment ibuprofen 800mg with ice prn.
Sore, red, and swollen arm, fever, body aches, nausea, loss of appetite. Took Aleve and baby aspirin.
An hour after vaccine swelling and redness started and by 9.27.23 Swelling and redness remained in addition to being warm to touch and very itchy. No hives or SOB noted. Had swelling last year but not this bad and did not have warmth or itching. Had reaction years ago with severe flu like symptoms so had not had another flu vaccine until last year when required by work.
Child crying for 2 hours, right leg swollen, red and tender. Brought to office; tender right thigh around area of injection site, 2" in diameter, swollen and hot.
3/31/98 partially deaf in lt ear;numbness in hands & feet;tingling shocking sensations down legs;unsteady gait;vertigo;bladder trouble;depression;memory loss;visual disturbances;labile mood;temp fluctuation;fatigue;dx multiple sclerosis;  Annual follow-up received on 10/4/00 states that the pt has ongoing symptoms of multiple sclerosis, numbness and tingling of hands and feet and in various parts of her body. Cognitive problems, visual problems, labile mood swings and weakness.
Within 30 minutes of leaving doctor's office and receiving vaccine patient start to feel weak and nausea. By the next day she was vomiting, had a fever of 102 and a very sore arm. 2 days after receiving the vaccine she went to student health clinic and they told her what she had was probably viral but upon looking at her arm, she had redness and puffiness. They marked the red circle with a pen so the patient could monitor for worsening conditions. By the next day, she continued to have a fever and nausea and the redness on area was worse so she reported to her local ED. At this time she received fluids and insulin due to high blood sugars and ketones from Type 1 Diabetes and received antibiotics for worsening redness, swelling and pain the her left arm.
Patient experienced syncope within 2 minutes of completing vaccination (vaccine order: FluMist, TDaP, MCV4, HPV9). Eyes rolled back in his head and he became unresponsive to vocal stimuli. Nurse supported his head and torso in the chair. He regained consciousness within one minute. After regaining consciousness, he was assisted to a mat on the floor, had his legs raised to a chair, and given juice. Patient reported continued dizziness for about 5 minutes after regaining consciousness, but denied nausea. After laying down for about 10 minutes, he denied dizziness and was helped to sitting, where he stayed about one minute. After being assisted to standing he denied dizziness, lightheadedness, nausea, or visual changes, upon which he left the clinic.
Effects started approximately 24 hours after injection with a mild headache. Within 2 hours of the onset of the headache queasiness and vomiting occurred.
pt recv vax & devel an inj site rxn characterized by swelling & a knot;pt recovered after 2 to 3 wk;
Vaccinated with Varivax on 09/04/01. Reported with dx of chickenpox on 06/25/03.
Fever ranging from 99,4 to 101.0 lasting for 12 hours starting at 8AM on 01/12/2023, extreme fatigue and muscle aches to the point of not being able to get out of bed. All symptoms resolved around 8 PM on 01/12/2023.
No additional adverse event reported; Caller is a pharmacist calling to report that improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient on 12AUG2022. No additional information provided. No additional AE reported. No PQC reported.     RECOMBIVAX HB- lot U; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient{s medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 12-AUG-2022, the patient was vaccinated with an improperly stored hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot number U008328 has been verified to be valid; expiration date reported and established as 16-DEC-2022), and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 has been verified to be valid; expiration date reported and established as 09-SEP-2023) for prophylaxis (doses, vaccination schemes, routes of administration, and anatomical locations were not provided).    The administered dose of hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) was stored at a temperature of 48.79 degrees Fahrenheit  (F), during a time frame of 2 hours and 43 minutes (conflicting information also reported as 22.87 F during a time frame of 3 hours and 36 minutes), and for varicella virus vaccine live (Oka/Merck) (VARIVAX) a temperature of 33.13 F was reported during a time frame of 14 hours and 55 minutes. No additional temperature excursion were reported for neither of the vaccines. No additional adverse event was reported.
Local 5"x6" reddened, heat and ? tenderness. R/o cellulitis in left thigh, in hospital x 2 days.Tx w/ Keflex & Benadryl. Discharge summary states final diagnosis to be left thigh cellulitis versus local reaction from vaccine.
A week after my second dose I was diagnosed with COVID-19. I lost my sense of smell to begin with. I went and got tested and went out with some friends. I got a call and from the local health department and they told me that I was positive. My main symptoms were loss of smell, severe upset stomach, diarrhea, and fatigue.
atrial fibrillation; pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EN6206) dose 1 via an unspecified route of administration, administered in arm left on 11Mar2021 09:00 (age at vaccination: 72-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received list of other medications (unspecified) within 2 weeks of vaccination. On 12Mar2021, the patient was Hospitalized for 3 days due to atrial fibrillation and pericarditis. No hospitalization was prolonged. Adverse events result in visit to doctor and emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19, which included nasal swab test on 18Mar2021 and result was negative. Therapeutic measures were taken with unspecified drugs as a result of atrial fibrillation and pericarditis. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: ER8733) dose 2 via an unspecified route of administration, administered in arm right on 31Mar2021 09:00 (age at vaccination: 72-year-old) as dose 2, single for COVID-19 immunization. The outcome for the both events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient received her second dose of the Janssen vaccine today. Pharmacist did not check her date of birth because this was her second dose. Patient is 17 years old.