chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold chills; vomiting; arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (arm sore), CHILLS (cold chills) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (arm sore). On 13-Feb-2021, the patient experienced CHILLS (cold chills) and VOMITING (vomiting). At the time of the report, INJECTION SITE PAIN (arm sore), CHILLS (cold chills) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt had swelling, redness, and pain that radiated around arm and almost down to elbow. Pt used ice packs, antihistamines, and otc pain relievers. Symptoms were diminishing, but not gone completely on 9-14-19 when she visited the pharmacy.
Developed chest pain and diagnosed with myopericarditis based on EKG and elevated troponins. admitted for monitoring
Patient received Pfizer vaccine at 1526.  Patient at 1535 started to c/o of scratchy/tingling throat.  Patient verbalizing well.  Skin color perfused. Lead site RN at bedside.  1540 Vital signs BP 120/70, P85, R 20 pulse ox 97 percent.  Patient states no history of allergies, calming reassuring patient.  Patient states it might be anxiety.  Breath sound auscuctated clear bilaterally.  1550: Education to patient by RN. Patient to be observed for 30 minutes.  Patent refused 911 call.  Patient drinking water.  Patient states no distress, discomfort to throat resolved.  1556 BP 120/88, P74, R16, pulse ox 98 percent.  1605:  Patient given education- instructed if any reoccurrence to call 911.  Patient states understanding. Patient signed to understanding.  Patient remains awake, alert, oriented x 4.  Skin color perfused w/d to touch.  Patient ambulatory on discharge with steady gait.
Initial report received from a healthcare professional on 22 April 2013.  A 33-year-old female patient had received first intramuscular dose of ADACEL (lot number U4612AA) in right deltoid on an unspecified date. The patient was pregnant. The last menstrual period date was 31 July 2012 and the expected date of delivery is 07 May 2013. The patient's health during pregnancy and risk factors were not reported. As per reporter, the patient had not experienced any adverse event. List of documents held by the sender: None.
This non-valid spontaneous report was received from an immunization official and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were inadvertently administered improperly stored doses of M-M-R II injection (lot # N009172 with expiration date on 20-MAR-2019; doses and routes of administration were not reported), which was reconstituted with properly stored sterile diluent (manufacturer unknown). Other improperly stored suspect therapies included ROTATEQ (lot # N013885 with expiration date on 09-DEC-2018 and not valid lot # reported as N024400 with expiration date on 10-MAY-2019; doses were not reported) and GARDASIL 9 (lot # N025428 with expiration date on 19-JUN-2020 and lot # N021571 with expiration date on 29-APR-2020; doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion of 55 degrees Fahrenheit, which lasted for an unknown time frame. There was an unspecified previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effect was reported.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/2/2022 Discharge Date: Sep 5, 2022  PRESENTING PROBLEM: Generalized weakness [R53.1]   HOSPITAL COURSE: 81 y.o. male with past medical history significant for dementia, coronary artery disease s/p CABG, ischemic cardiomyopathy, type 2 diabetes, hypertension, depression,BPH who presented to the emergency department with complaints of generalized weakness.  Patient does have a history of dementia and was A&O x 1-2 on admission.  Patient lives in assisted living with his wife at House.  Patient had exposure to COVID positive worker and tested positive for COVID 19 on 09/01.  Patient had noted to have slightly more confusion and was getting up at night which is abnormal for him.  This led to mechanical falls.  Upon arrival to the emergency department, patient was initially brought in as a STEMI.  EKG performed by EMS reportedly had ST elevations in V1 through V3.  EKG was obtained emergency department which did show some minimal elevation in V1 and V2 but this was noted in several prior EKGs and presentation was not consistent with STEMI/ACS.  Baseline blood work was obtained and independently reviewed.  Blood work was remarkable for BNP 4145, stable chronic anemia, troponin 40 with repeat of 42, D-dimer 1130. With reports of falls, imaging was obtained.  CT head and CT cervical spine were negative for acute process.  With elevated D-dimer, CT thorax was obtained.  CTA negative for acute PE.  With elevated D-dimer, CT thorax was obtained.  CT was negative for acute PE.  Showed dependent atelectasis in both lungs and trace left pleural effusion.  Superior endplate compression deformity at T12 was visualized without significant changes from prior imaging.  There was a somewhat irregular appearance of the vertebral body with areas of lucency of unknown significance in the T12 vertebral body.  Patient was given a dose of aspirin and home dose of metoprolol.  Patient admitted for further care.   Patient remained asymptomatic from COVID-19 standpoint on room air during the entire hospitalization.  Mentation in setting of chronic dementia remained at baseline.  Remdesivir 3 day course completed.  Patient denies urinary symptoms (however dementia).  Urine culture returned aerococcus and one dose fosfomycin given.  Noting patient clinically stable discussed with family and care management and ultimately decision was made to return patient to his current assisted living situation with his wife.  He will be monitored and if family feels he is starting to need increased level of care arrangements will be made in the outpatient setting.
anaphylactic reaction; Throat was closing up/tighten, sore and itchy throat; Everything was going numb; Nauseous; sore and itchy throat; sore and itchy throat; This is a spontaneous report from a contactable consumer (patient's mother). A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FC3181), via an unspecified route of administration, administered in left arm on 19Aug2021 at around 15:30 as dose 1, single (at the age of 15 years), for covid-19 immunization, at pharmacy. Vaccine was not administered at military facility. It was told that they should get it, needs to be done, protection when going back to school, doctor recommended it. Medical history was not reported. There were no concomitant medications (Other Products: No). There was no family medical history relevant to adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The patient previously received Flu shot (Vaccination Date: Unknown) and had an allergic reaction to the Flu shot. Caller did not know the date of this vaccine or the NDC, Lot Number, or Expiry date for the vaccine. Caller states that this occurred when her daughter was in Kindergarten. Caller stated her daughter had all of her other vaccines and never had any reactions. There were no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. The mother reported that, her daughter got the first dose of the Pfizer-BioNTech Covid-19 Vaccine and on the same day on 19Aug2021, experienced anaphylactic reaction (tighten, sore and itchy throat), everything was numb and she was nauseous that lead to them ending up in urgent care and emergency department to be further treated. She explained in detail that, her daughter was taken to the Emergency Room and as a corrective for all the events she was given an EpiPen that helped immediately and her daughter was also given steroids and was monitored, admitted, and treated in the Emergency Room for 5 hours. She said that her daughter was currently sleeping in her bedroom and was doing better, and she had to go pick up more medication for her daughter this morning that she would take for the next 10 days. She stated it was so scary yesterday. Patient Medical was not continuing. No investigation assessment was done. Adverse events resulted in visit to emergency room and physician office. There were no relevant tests. The outcome for all the events was reported as recovering, at the time of report.  Follow-up attempts completed. No further information expected.
rash that came on "all at one time" and seems to be anywhere, from: "under his arms, down his torso, on his stomach, down to his groin, and down his legs"; The rash goes from itchy to burning then progresses to pain; The rash goes from itchy to burning then progresses to pain; This is a spontaneous report from a contactable consumer (patient wife) via medical information department.   A 70-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 06Mar2021 (Saturday), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Mar2021, 4 days later Wednesday the patient develop rash all at one time and seems to be anywhere his clothes touch him from under his arms, down his torso, not as noticeable on his stomach, down to his groin, and down his legs. The rash was incredibly itchy, randomly getting worse. The rash goes from itchy to burning then progresses to pain. The urgent care prescribed steroids and antihistamines, Benadryl and Pepcid- not enough to keep him comfortable but neither seem to be helping to keep him comfortable. No other changes to lifestyle and have not been going out in public. The reporter queried should he take his second dose of vaccine and what recommendation to treat patient rash. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
11OCT96 pt phoned w/very hoarse whisper-like voice;pt stated @ around 7PM 10OCT96 throat became sore & irritated causing hoarseness & a feeling of closing off similar to a terrible cold or bronchitis;advised to get med care;dx allerg rxn;
Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and extension of fusion from T4 to the pelvis two months after vaccination. During surgery patient became thrombocytopenic and required massive transfusion. Thirteen days after surgery found to have bilateral pulmonary embolisms and deep vein thromboses and placed on anticoagulation. Patient subsequently suffered cardiac arrest and was unable to be resuscitated.
This spontaneous report as received from a company representative refers to her daughter, a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On unknown dates in 2016, the patient received her first and second doses of GARDASIL (doses, route of administration, lot numbers and expiration dates were not reported). The reporter stated that the patient received the doses "more than 2 months apart". Then on 27-JUL-2016, the patient received a dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported), which was "more than 4 months" since the second dose of GARDASIL was administrated. No concomitant therapy was provided. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected as no permission has been granted to contact a physician.
09/15 pt called complaining of red bumps under left axilla that itch at times and bruised sore area on top of left shoulder at clavicle area that's beginning to feel better.
Around late July 2021, I began experiencing erectile dysfunction. Upon further testing, I had low testosterone.
COVID symptoms started on 12/18/2021 with headache, cough, sore throat, eye pain, and tiredness. Headache has gone away but he still has sore throat and cough. Tested positive for COVID on 12/21/2021.
Fever; body ache; chills; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills and body ache after second shot on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started with stiffness and pain in left arm, then overnight on 12/19/18 became extremely sore red, hot, swollen 10in x 10in square. Treated with cephalexin 500mg 1 QIDx7days.
Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Received TDAP 4/21/09.  At 7/7/09 visit c/o achy left shoulder to fore arm with increased pain with movement since injection.  Stated when she was a baby she had some kind of vaccine reaction & was given a smaller dose.
Later that evening my arm was swollen and I had a low-grade fever. It also felt really warm where the shot was given. Not the next day but the following day it was hard to move my arm and it was really sore for several days. I did not seek care from a doctor.
I've had major aches in muscles (legs & arms) and hip joints; I've had major aches in muscles (legs & arms) and hip joints; This is a spontaneous report from a contactable consumer (the patient). This non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL 1283), via an unspecified route of administration, administered in the left arm on 12Jan2021 at 08:15 AM (at the age of 72 years) as a single dose for COVID-19 immunization. Medical history included Barrett's oesophagus. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported "I've had major aches in muscles (legs & arms) and hip joints on 23Jan2021. No treatment was given for the event. The clinical outcome of  major aches in muscles and hip joints was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Had a red raised area where the shot was given about the size of a golf ball. Very itchy, no warmth.  Called 11/1/2021 at 3pm to report this reaction. States area is already much better, no itching today.
pt recv vax 17JUN96 & mom called office on 20JUN stating pt had broken out w/small bumps all over body;then called back stating pt had large welts all over body
This case was reported by a physician and described the occurrence of taste loss in a 31-year-old male patient who received Influenza vaccine quadrivalent. On 30th September 2015, the patient received influenza vaccine quadrivalent. On an unknown date, 10 days after receiving influenza vaccine quadrivalent, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was recovering/resolving. It was unknown if the reporter considered the taste loss to be related to influenza vaccine quadrivalent. Additional details were received as follows: The patient received influenza vaccine quadrivalent and after 10 days he experienced acute loss of taste. The sense of taste was gradually improving over subsequent 2 weeks. The patient denied of having any sinus or nasal congestion, post nasal drip and fever. The patient was asking if ageussia or hypogeusia were reported response to flu quadrivalent vaccine.
Patient reports that 27 hours after second vaccine she started having fatigue, body aches,  sharp stomach pain, diarrhea, vomiting, and weakness that have persisted for 4 days.
Day 1-body aches. Day 1/2-middle of night- high fever 101-102, extreme chills, labored breathing during night lasting approx 30 min,. Day 2 -High fever102 continued, extreme chills next day, body aches, SOB, cough Day 3 - 9am, fever broke, body aches, cough, headache, dizziness
Called me and told me that when they had an IUD implanted they passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "bad allergies in general" (unspecified if ongoing), notes: known allergies: bad allergies in general; "weight issue" (unspecified if ongoing), notes: weight issue, at one point had a higher BP but do not think that is case now; "at one point had a higher BP but do not think that is case now" (unspecified if ongoing), notes: weight issue, at one point had a higher BP but do not think that is case now. The patient took concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "Called me and told me that when they had an IUD implanted they passed out".  Additional information: List of any other medications the patient received within 2 weeks of vaccination: Likely, but unsure what. Patient told that when they had an IUD implanted they passed out. They could not make out clearly the words the doctor was telling them right before it happened. I am not sure when this procedure was - Caller know that they have taken other contraceptive previously. Post-procedure, they said it was only "bad for a day". Received both shots for Pfizer around first half of 2021. It was Unsure if this related to anything with the vaccine but reporting out of caution.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Loud, shrill constant ringing in my ears.  Went to ENT who could not determine cause but called it genetic.  Ringing in ears coincided EXACTLY with the start of extreme dizziness. light-headedness, vertigo.  Tinnitus has never stopped.  Vertigo came, remained for 6-7 months, was gone for several months, then recurred about 4 months ago and has remained ever since.
Client reports pain at site of injection started immediate up receiving vaccine and has continued to be very painful to move upper arm, tender to touch.  Reports pain has worsened and has interfered with ability to lift things.
COVID-19; flu-like symptoms; kind of weak; little bit dizzy; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart rate), INFLUENZA LIKE ILLNESS (flu-like symptoms), ASTHENIA (kind of weak), DIZZINESS (little bit dizzy) and COVID-19 (COVID-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced HEART RATE INCREASED (fast heart rate), ASTHENIA (kind of weak) and DIZZINESS (little bit dizzy). On 31-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 06-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, HEART RATE INCREASED (fast heart rate), ASTHENIA (kind of weak) and DIZZINESS (little bit dizzy) had resolved, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown and COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: (Positive) positive. On 25-Jan-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021 and Added reporter's email address
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. The patient was inadvertently administered with expired FLUMIST QUADRIVALENT on 27-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
11/28/22 presents to ED for "shortness of breath". PMHx of "A. fib, breast cancer, lung cancer, hypothyroidism, GERD"
EPILEPSY, UNSPECIFIED 4/26/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART
Myalgia chills Narrative:  Employee reports experiencing body aches and chills approximately 12 hours after receiving 2nd dose of vaccine. Reports took Theraflu for symptoms (no dose/duration provided). States has fully recovered.
pt presented to EMS with increasing confusion for several days; painful, frequent urination; DNR/DNI; pt diagnosed positive for COVID, pneumonia, sepsis, UTI; pt's condition deteriorated and she passed away in the hospital
Hospitalization for COVID19, pneumonia with hypoxemia 2/23/22-3/6/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily. Discharged to hospice 03/06/22.
Patient was sitting in the waiting area after his vaccine. Within 5-10 mins of his vaccine he recalls suddenly feeling warm then he was observed convulsing in his chair. He fell over to the side, hit a metal bin, then fell forward onto the floor, hitting his head. It took him a few seconds to regain consciousness. Pharmacist 1 called 911 and pharmacist 2 attended to patient until EMS arrived. EMS reported he was very pale and blood pressure was low. Patient declined transport to the hospital.