chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am 48 years old / I have a prescription to get the shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (Shingles on face).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient was 48 years old at the time of reporting and had a horrible case of shingles on face and had a prescription to get the shingrix vaccine, which led to intercepted drug prescribing error. The patient added that, he/she could not find anyone to give it since the patient was under 50 years of age had insurance and also insurance says they will not pay until the patient became 50 and the patient could not afford the vaccines The reporter did not consent to follow up.
developed congestion in nose; joint aches; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, within the next 18 hours, the patient developed congestion in nose, over the next 72 hours the patient developed joint aches and the symptoms have lasted for 96 hours. The outcome of events was unknown.
Syncope upon rising this am, rested on cold bathroom floor, sweating profusely, nausea, vomiting
Body aches, nausea, vomiting, headache, dizziness, difficulty breathing
Headache, Myalgia, Fever, NauseaVomiting, chills, site tenderness Narrative:  Headache, fever, myalgia, nausea, chills, site  tenderness.
Upper arm very swollen, inflamed hot red. Patient went to her doctor received MEDROL dose pak.
Admission Date: 10/21/2022 Discharge Date: Nov 2, 2022 Discharge Provider: MD Primary Care Provider: MD    PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC)   HOSPITAL COURSE: Patient is a 72 year old with COPD, tobacco / alcohol abuse, HTN, CKDIIIb, hyperparathyroidism, GERD, and distant prior partial gastrectomy due to stomach tumor.  She presented 10/21 with weeks of generalized weakness, fatigue, dyspnea, and nonproductive cough, progressive despite completing 8 of 10 days of outpatient Augmentin and 7 days of Prednisone.  CTA chest showed extensive RLL endobronchial debris and infiltrate, moderate-severe upper lobe predominant emphysema, no PE.  She was COVID-19 (+) but imaging was more concerning for aspiration pneumonia for which SLP was consulted (bedside eval showed oropharyngeal dysphagia, VFSS was unable to be completed).  Sputum from 10/22 actually grew many Serratia / PsA (antibiotics changed to Cefepime pending sensitivities).  On 10/23, she was moved to ICU with respiratory distress requiring BiPAP.  Precedex was needed due to claustrophobia.  By 10/24, she was able to wean down to nasal cannula but AM CXR showed moderate right PTX.  IR placed chest tube.  Later on 10/24, she developed rapid Atrial fib for which Amio gtt / enteral Lopressor was started.  Lopressor was titrated and she converted to NSR 10/25, amiodarone discontinued.  VFSS 10/25 showed large CP bar versus Zenker's diverticulum with associated significant esophageal retention - dysphagia diet / swallow strategies initiated.  She was transferred out of the intensive care unit and did well.  Discharge was delayed while waiting for pneumothorax to resolve and her chest tube was ultimately discontinued on 11/01.  Repeat chest x-ray today showed no recurrence of pneumothorax.  She continued to require 4 L of oxygen and the patient was discharged home.  Home oxygen was arranged.  She will continue with the prednisone taper
high fever; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever in Feb2021 on last Thursday. The patient underwent lab tests and procedures which included body temperature was high in Feb2021. Reporter would like to know if getting a shot would be contagious with covid for her daughter as they were together. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Had mosquito-like bumps, bigger than regular mosquito bites, about 4 or 5 bumps in  area of arm close to elbow.  bumps were irritating and itchy.  went away after 12 hours. no signs of bumps, itchiness after 12 hours.
I am covered over my entire body with spots similar in appearance to idiopathic guttate hypomelanosis.
Several hrs after vaccination developed an area of redness & heat on R arm at injection site. This turned into swelling & pain. On 11/20, she developed redness throughout & itching. Almost resolved by 11/25/09 & requested BENADRYL for the itching.
24 hours post vax, the pt experienced severe myalgias, arthralgias, and swelling of her ankles, knees, and other joints.
After receiving the vaccine I had a fever, pains, felt lethargic, and it made me feel worse than the flu. Every day for about a week new symptoms came up. I might of taken some acetaminophen to relieve some of the symptoms. I still have a little bit of phlegm in my throat. I had a huge tumor removed out of my sinuses about a year ago. When I went to my doctor he said that there are signs that a tumor is trying to come back. I caught COVID in January 2022. I felt a little under the weather, but I didn't really have any symptoms. I was in a nursing home where COVID was high, and I had ended up catching it.
Malaise, hives. Pt stated went to ED. This was discovered when pt was in office today, MD ordered Tdap update and pt declined, " I was miserable for days and don't want another ever, hives lasted days."
Recieved vaccine Friday afternoon with small rash on both arms approx. 6 hours after first dose. Continued to be itchy the next day (Saturday) with no obvious rash. Sunday still itchy and obvious small bumps on both arms. Monday (after taking allergy meds) rash gone but just a little itchy.
pt recv vax & devel an inj site rxn characterized by swelling, redness, warmth & pain as well as a fever;
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 23-OCT-2018 the patient was vaccinated with expired VAQTA (lot # N016805 with expiration date 04-SEP-2018) for prophylaxis. The VAQTA did not have any temperature excursions prior to administration. No adverse symptoms were reported.
fast heartbeat; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heartbeat) and HYPERTENSION (high blood pressure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (fast heartbeat) and HYPERTENSION (high blood pressure). On 11-Mar-2021, PALPITATIONS (fast heartbeat) and HYPERTENSION (high blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: high (High) High. On 11-Mar-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
hives on neck, face/ forehead, spread down to chest and stomach. itchy. onset 8:00AM on 3/7/21, after receiving second dose Moderna on 3/5/21. lasted about 12 hours.
I have been extreme fatigue without specific reason, no energy, weakness,  muscle and body aches, exhaustion. All started from the day I received the vaccine and continues to this day.
Client fell at home on the night of 01/29/21, woke up on 01/30/21 with left sided weakness, dysarthia, left sided facial weakness, left hand pain and swelling.  Client transported via ambulance and admitted to Hospital.  Transferred to rehab care on 02/02/21 and discharged on 02/16/21.
Redness, swelling, soreness and warm to touch for a 3 inch diameter area around injection site.  Started 24 hours after injection and ended 84 hours after injection.
This retrospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) during pregnancy. The subject's medical history included previous pregnancies include two full term. On 26 September 2012 the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown). Her last menstrual period was on 18 August 2012 and estimated date of delivery was not provided. The subject used no contraception and the pregnancy was by normal conception. On 26 September 2012, at the time of vaccination with CERVARIX, the subject experienced vaccine exposure during pregnancy. The subject received her 3rd dose of CERVARIX on 26 September 2012. Later that same day, the subject received a positive pregnancy test. The subject decided to terminate the pregnancy for reasons unrelated to CERVARIX vaccination [elective aborted pregnancy]. At the time of the report no additional information was available. The outcome of the pregnancy was elective termination with no apparent congenital abnormality.
PATIENT STATED THAT AFTER SHE ARRANGED HER SHIRT SLEEVE FOR THE SHOT, SHE WAS GIVEN THE SHOT IMMEDIATELY WITHOUT WARNING AND IT WAS SHOT " LIKE A DART".  THE PHARMACIST DID NOT WARN HER SHE WAS ABOUT TO GIVE IT, AND THE PATIENT SCREAMED .  THE PATIENT STATED THAT THIS WAS THE MOST PAINFUL SHOT THAT SHE HAS EVER HAD AND THAT THE PHARMACIST DID NOT HOLD HER ARM TO ADMINISTER THE SHOT AND WAS NOT GENTLE.  PATIENT STATES THAT EVEN AT 10 PM THAT NIGHT SHE HAD TO TAKE MELOXICAM FOR THE PAIN
left arm felt sore. She was nauseous, dizzy and had body aches, including back pain and pain extending down left leg into foot. Left arm became swollen to the hand as the day progressed and has had difficulty moving the shoulder
2nd day after receiving TdaP imm., pt. was sitting sewing at approx. 10:30am and had magnified circles in front of both eyes.  Vision was not affected.  Then the pattern went to a rainbow, zig zag pattern travelling across the line of vision.  Lasted about 15 minutes.  Pt. went to ER to be evaluated, with neg. findings.  Called her optometrist and he said it sounded like occular migraines.  It was the first and only time the pt. has had these symptoms.  Has had no further symptoms.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported and route was subcutaneous). Concomitant medications were not reported. The nurse reported that she properly administered ZOSTAVAX, subcutaneously in the deltoid muscle but the patient felt that the dose was not administered properly (should have been administered in the back of the upper arm. No adverse effect was reported. Additional information is not expected.
Four months after COVID-19 vaccine dose 3, had Shingrix vaccined then developed a rash throughout body; Doctor prescribed Clobetasol Cream, but it didn't help; Doctor then took a Biopsy of Lesions and determined it was Psoriasis; Was prescribed Skyrizi and it seems to be helping.
notes: times are approximate. I got the vaccine on day two of my period.    I moved my arm a lot after getting the vaccine. My arm did not hurt, even though the rest of my body ached.  4-27-21 2:45pm: got the vaccine in my left arm.  4pm: felt fine. slightly more energy, clearer head than usual. this good mood and clear head only lasted a few hours. it ended before other symptoms began.  9pm: minor body aches, but not in arm where I got the vaccine. minor chills, shivering. 10pm: began to feel worse. moderate body aches, chills, dizzy.  10:40pm: suddenly felt much worse.  severe chills, shaking, dizzy, then felt very hot, nausea. vasovagal syncope. sudden low blood pressure. did not actually faint since I know how to prevent fainting. took ginger, drank a lot of water, got ready for bed.  lying in bed. felt nauseas for a few hours. this was the most uncomfortable symptom. frequent peeing. thirsty, but water went right through me. sweating. could not really sleep, not totally awake either. felt horrible.  after a few hours, still lying in bed. nausea mostly went away. headache, muscle pain in jaw and face were the worse symptoms at this time. frequent peeing. thirsty, but water went right through me. sweating.  felt like someone had turned the heat up.  when I checked, the heat was off. felt like I had a fever for a few hours.  4-28-21 1:45pm: got out of bed. feel better than the previous night, but generally unwell. short of breath when moving. fatigue. 6pm: dizzy, weak.  4-29-21: 3pm: mild headache, feel mildly hot.  4-30-21: 10pm: tense muscles, especially in my face and head.  5-1-21: sore breasts.  5-4-21: hormones feel unbalanced.   PMS symptoms, but it is a few days after my period ended. intense negative moods, spotting, sore breasts.
I had my vaccination on 10/20/2022. In 11/2023 I had flare up of my Emphysema. I went to my physician and gave me antibiotics and prednisone. My condition did get better over time. I had surgery in 02/2023 that was scheduled prior to the flare up to treat my Emphysema.
most horrible pain I ever felt on my neck and face; most horrible pain I ever felt on my neck and face; scabs off my face; This case was reported by a consumer via Interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain, facial pain and scab. On an unknown date, the outcome of the neck pain, facial pain and scab were unknown.   It was unknown if the reporter considered the neck pain, facial pain and scab to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient stated that, the patient received shingles vaccine and experienced horrible pain on neck and face. The patient also stated his/her boss made go to work and the patient literally shaved the scabs off face, it was highly contagious.
nausea; vomiting; Patient received an extra of MENACTRA administered; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Information (Reference number- 00802399) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 14-year-old female patient who experienced nausea and vomiting after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (extra dose administered).  The patient's past vaccination(s) included MENACTRA on 18-SEP-2020. The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 06-Oct-2021, the patient received a second dose of 0.5 mL suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Solution for injection, lot U7140BA, expiry date 07-Oct-2022) via intramuscular route in the left arm for prophylactic vaccination.  On 07-Oct-2021, the patient developed non-serious nausea and vomiting, 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was an actual medication error due extra dose administered (latency : the same day).  At time of reporting, the outcome was unknown for the event.   It was reported "their second dose of MENACTRA in the office on 06-Oct-2021 after receiving their first dose on 18-Sep-2020.This patient received the second dose 2 years too early. Patient has had nausea and vomiting which started on 07-Oct-2021".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT WAS GIVEN FLU VACCINE INTENDED FOR CHILDREN ABOVE 3 YEARS OF AGE. FAMILY WAS NOTIFIED OF MISHAP. THERE WAS NO REACTION TO VACCINE.
syncopal episode, positive LOC, positive vomiting, TP to ER by EMS for further eval at req of parent. Pt stable, A and O at time of transfer.
Fever then seizures 10 minutes long, have had them ever since, treatment was drug CT. After various doctors, new doctor ran MRI, MS, Telemetry, Radio Brain spectrum ad Pet Scan. Reviewed the past records and in 2000, said it was most likely the vaccine. Per doc 213024, severe seizures + mental retardation.
Rash- has been to 2 Doctors who say it is not related to the ZOSTAVAX injection.  Rash is over trunk but she feels it is spreading.
Moderna 4/27/21, 5/26/21. Positive on 12/5/22
Many of us have gotten sick from this flu vaccine, feeling like we have the flu (fatigue, nausea, muscle aches, headaches, etc).  None of us have ever had such a bad reaction to a any vaccine before so I thought I should report it in case something was wrong.
After vaccination, Pfizer notified facility that the vaccine became too cold in transport. Revaccination was completed.
Pt admitted s/p an allergic rxn to flu vaccine.  She experienced sudden onset shortness of breath and wheezing.  She was transferred from the nursing home to emergency room, where, despite corticosteroid injection, epinephrine inj and aerosol treatments, she was still wheezing and somewhat sob.  It was decided to admit her.  Her O2 sats remained above 90% during this, and there was no respiratory arrest.  During her stay, she gradually improved and was discharged back to the nursing home 12/17/04. Discharge summary states Bronchitis. msv
Dizzy vertigo trouble swallowing at times weight loss feelings of heaviness in back of head/neck weight loss unable to walk without walker trouble standing getting out of bed blurred vision Continuing to go down hill since after shot.  Been to ER X2. MRI X2  CT scan x1.  ENT Dr.  Eye Dr and Neurologist. Referral to medical facility
Patient felt fine immediately after shot and walked around to sit and wait for 30 minutes.  After 20 minutes of sitting, she starting seizing in her chair.  Her head tipped to the side and her right arm straightened and she seized for approximately 5 minutes.  She started coming to which took approximately 5 minutes until she was fully answering our questions.  She was checked out by our on-call physician, Dr.  We let her sit for a full 20 minutes or so and then she was able to leave and go home on her own two feet.
We arrived on 02/10/2021 to give second doses to residents at facility. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
Information has been received from a certified medical assistant concerning a 20 year-old male student with severe asthma, allergies to penicillin and AVELOX and a history of frequent bronchitis who on 13-DEC-2006 in the evening was vaccinated intramuscularly with a 0.5 mL second dose of Pneumovax 23 (Lot # 655590/0885F).  Illness at the time of vaccination included upper respiratory infection and pharyngitis.  The next day ("about 24 hours after Pneumovax 23 was given"), the patient experienced flu-like symptoms with a high temperature (reported as 88 degrees), difficulty breathing and terrible injection site pain, swelling and redness.  The patient was also having some neck and muscle pain.  He was seen in the emergency room and was released.  On 15-DEC-2006, the patient was not able to move his arm and was seen by his doctor.  The injection site was erythematous and somewhat tender.  A diagnosis of cellulitis at injection site was made.  The patient was treated with ROCEPHIN IM 1g and LEVAQUIN 500 mg QD.  The patient was tested for meningitis and the cultures were negative.  Follow up was performed in 3 days and improvement was noted.  The patient recovered on 15-DEC-2006 after the appointment.  No product quality complaint was involved.  Additional information is not expected.
Swollen left clavicular lymph node and right axillary lymph node, nausea, fever, chills, loss of appetite greater than 24 hours  Swollen left clavicle lymph node not resolved.
stomach very sensitive; loss of appetite; felt very very sick and wanted to throw up; nausea; 102.2°F fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DYSPEPSIA (stomach very sensitive), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (body aches), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up), NAUSEA (nausea) and PYREXIA (102.2°F fever). On 14-Feb-2021, the patient experienced DYSPEPSIA (stomach very sensitive). On 14-Feb-2021, NAUSEA (nausea) had resolved. On 16-Feb-2021, PAIN (body aches), DYSPEPSIA (stomach very sensitive), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up) and PYREXIA (102.2°F fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 102.2°F.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.