chrisvoncsefalvay/vaers-outcomes huggingface dataset:
? 10/25/2021 11:00 am blurred vision last approximately 1 hour. ? 10/25/2021 11:30 am hands shaking lasted 45 minutes. ? 10/25/2021 12:30 pm after eating a corndog felt nauseated last 15 minutes. ? 10/25/2021 1:40 pm slight headache.
9/6/21 Pt to ED c/o fatigue. Pt reporting fatigue since left hip injury 5 years ago but reporting increased fatigue x1 week.
Patient notified the Pharmacy of the situation on 10/7/18. She complained of vision changes and being sensitive to the lights at store, where she works. This started on 10/5/18 at around 8 pm. She left work early that day. It happened again on 10/6/18 at 8 pm and she left work early as well. She has no issues at home or anywhere else per patient.
10 minutes after injection of Janssen vaccine patient became nauseated, HR dropped into the 30's and she vomited.  Symptoms lasted 2 minutes and she returned to baseline.  No subsequent recurrence of symptoms.
At the same appointment for 15 mo. check up/vaccinations, patient was also diagnosed with an ear infection and was prescribed amoxicillin. She was then given the immunizations - one being MMR-V. Exactly one week later she had a very pronounced rash (large-different sized and shaped, raised red blotches) from head to toe. She also had a high fever (104 degrees). I took her back into pediatrician and they felt very strongly that she was having a reaction to the amoxicillin and they called her reaction erythema multiforme. I was told to watch her closely, give her Motrin or Tylenol for fever as well as 2 different anti-histamines Atarax (prescription) and Benadryl. Her condition continued to worsen - fever continued and then joints swelled up (hands and feet). I took her back into pediatrician again (3 days after 1st visit) and he put her on a steroid (Prednisone). This cleared her symptoms very quickly. As of now, she is fine and we see no adverse events. She had amoxicillin on two other occasions before this and had no other reactions. I personally feel that her reaction had something to do with the immunization (particularly MMR-V) and the amoxicillin anti-biotic given simultaneously. Our pediatrician encouraged up to send this information in to you so that it is documented.
had the Moderna vaccine on September 18th then acquired Covid on October; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October). At the time of the report, COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, SARS-CoV-2 test: positive (Positive) acquired Covid on October 18th.     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.   No concomitant No treatment medication were reported. Reporter stated that one of the student had the Moderna vaccine on September 18th then acquired Covid on October 18th and went to get her second shot. She was denied.  Company comment: This case concerns a  female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected ADR event of COVID-19. The event occurred 1 month after the first dose of the mRNA-1273 COVID-19 vaccine. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected ADR event of COVID-19. The event occurred 1 month after the first dose of the mRNA-1273 COVID-19 vaccine. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Swollen Lymph node in arm pit that has not subsided as of today 1/14/2021
First day:  Very fatigued, with severe swelling of arm from shoulder to elbow.  Muscles in back of arm extremely tender.  Ran fever alternating with chills and severe shaking.  Second day, still somewhat feverish and extremely tired, slept most of day.  Third day, arm began improving, but still very tired.
COVID+ 12/3/2022  Vaccination status J&J x1 + Pfizer x1 hospitalized x2 12/3/22-12/5/2022 & readmitted 12/7/22 BRIEF OVERVIEW: Discharge Provider: Doctor Primary Care Provider: MD Admission Date: 12/3/2022 Discharge Date: Dec 5, 2022   Active Hospital Problems   Diagnosis Date Noted POA  COVID-19    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Confusion [R41.0] Pneumonia of both lower lobes due to infectious organism [J18.9] COVID-19 [U07.1]   HOSPITAL COURSE: 97yo F admitted with concerns of acute hypoxic respiratory failure secondary to COVID pneumonia. Desaturated to 80s on RA requiring 2L oxygen. COVID positive. CXR revealed hazy patchy bilateral lower lung opacities suspicion for superimposed bacterial pneumonia. Respiratory status improved, weaned off oxygen. Mentation at baseline per son, given baseline dementia. Evaluated by PT/OT/SLP. Patient medically stable for discharge home with son and home health on 12/5.  12/7/22 re-admission:  BRIEF OVERVIEW: Discharge Provider:  DO Primary Care Provider at Discharge: MD  Admission Date: 12/7/2022 Discharge Date: 12/13/2022   Active Hospital Problems   Diagnosis Date Noted POA Dysphagia 12/13/2022 Unknown  Acute ischemic left PCA stroke (HCC) 12/07/2022 Yes  Dementia (HCC) 03/16/2021 Yes  Paroxysmal atrial fibrillation (HCC) 04/09/2020 Yes  Stage 3b chronic kidney disease (HCC) 01/06/2014 Yes  HTN (hypertension) 10/18/2011 Yes   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute ischemic left PCA stroke (HCC) [I63.532] Cerebrovascular accident (CVA), unspecified mechanism (HCC) [I63.9]   HOSPITAL COURSE:   Patient is a 97 y.o. female with history of AFib not on anticoagulation, hypertension and recent admission for COVID pneumonia/hypoxic respiratory failure who presented to the hospital today from home after noted to be more confused and trouble with walking/ambulating.  CT with left PCA territory acute infarct, CTA proximal PCA occlusion.  No tenecteplase administered (out of window).  Has paroxysmal atrial fibrillation not on anticoagulation due to recurrent falls/dementia.  She was seen by Neurology for acute stroke.  It was felt that given her age and obvious cardioembolic source, with contraindication to anticoagulation, that no further workup should be pursued.  Due to COVID-19 positivity equal (12/03/2022), she was kept in severe respiratory precautions.  She was seen by Physical therapy/Occupational therapy and subacute rehab was recommended however the patient did improve, and family felt comfortable taking her home with home PT, OT, nursing.   Please note that the family also deferred adding Lipitor at discharge, the patient has advanced dementia, and they would like minimal medication changes if at all possible.  They are focus more on her quality of life.     On the day of discharge, patient's neurological examination is unchanged, she has a right hemianopsia.  No other focal neurological findings identified, she is anxious to discharge.   Consult Neurology
Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        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.   No concomitant products were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Additional information was received and primary reporter's details updated and event description updated. On 11-Aug-2021: Additional information was received and primary reporter's details updated.
bad pain in left arm (worsened); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 16Mar2021 15:00 (Lot number: EN6205) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "not recovered", described as "bad pain in left arm (worsened)". Therapeutic measures were taken as a result of vaccination site pain. Additional information: It was also reported that the patient was unable to dress herself due to the left arm pain. When she rests her arm, the pain goes away. But when she moves her arm, the pain comes back. Treatment included unspecified pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no family medical history relevant to the event.  No follow-up attempts are possible. No further information is expected.
Nausea was first noted followed by a sudden tachycardia with pulse in the upper 130's. With this my tongue and mouth began to tingle and it felt like I had something stuck in my throat. The facility gave me liquid benadryl immediately (50mg). Symptoms began to improve over the hour and a half that I was monitored and had fully resolved 3 hours post injection.
Initial report received on 29 November 2008 from a physician. An 81-year-old male patient, had received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 on 28 October 2008, and the following day, developed a 4cm painful lump at the injection site. He subsequently developed generalized fatigue, pain in his legs, and aching in his body. At the time of this report, all symptoms were still persisting. The patient has extensive medical history that includes penicillin allergy, history of cerebrovascular accident (CVA), Type I Diabetes, hypertension (HTN), vitamin D deficiency, mitral valve disorder, anemia, atrial fibrillation (A-FIB), aortic valve disorder, thrombocytopenia, testicular hypofunction, edema, and hyperlipidemia. It was not reported whether the patient received any treatments for the symptoms, but it was reported that no relevant diagnostic tests or laboratory data were performed. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single (Lot number: 014M20A) and on 26Mar2021 as dose 2, single (Lot number: 038A121A), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Jun2022 at 14:30, outcome "recovering", described as "Tested positive for COVID"; COVID-19 (medically significant) with onset 28Jun2022 at 14:30, outcome "recovering", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive; (28Jun2022) Positive.  No follow-up attempts are possible. No further information is expected.
I had stable MGUS for for at least 1.5 years.   A few months before 3 shot (first booster) had stable monoclonal gammopathy.  Within 8 weeks of booster, significant increase in gammopathy and then new diagnosis of Multiple Myeloma.
She got her vaccine, she was very tired and her arm was aching for a couple of days.  Then she had the tiredness, a lot of aches and pains, it was weird as it started on her neck and went down the left side of her shoulder to her waist, and never on the right side, like a severe toothache in her back.  She took Advil for the pain and it went on for a few days.  She did not have a cough or fever, but just the aches and pains.  Then severe days later she had a severe reaction to GERD, and her stomach was torn up with indigestion.  At first she did not think it was from the shot, but did not what else it would have been and had to double up on her stomach medicine.  She talked to her doctor on the phone and he's the one who increased her stomach medicine and had her take the Advil for the aches and pains and told her to rest until it passed.    She subsequently had the booster when she did ok, had a sore arm but did not have the acid reflux issue aggravated or the aches or pains with that.   She had the booster on 11/26/2021.      She did not suffer from COVID until 11/22/22 and feels that the vaccine had helped her not to get it until now.
Covid arm reaction 8 days after first dose. Raised itchy circular rash about the circumference of a tennis ball. Lasting for about 3 to 4 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: AS87164B) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: X-ray die" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 16Feb2023 to 20Feb2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
2 minutes after injection began to itch around mouth, tingling in L. arm Localized swelling
Pt c/o feeling clammy, diaphoretic, hyperventilating, feeling faint. BP 90/60 RR 22 FSBS 166 P 70 Spo2 98% RA. Ems on site took over care of pt, started IV and transported via stretcher to ER.
Around a month after the vaccine, I was waking up in the mornings congested. Off and on congestion that I normally did not have. I am still having those issues right now. It has been a year since October 2021 that I have been having congestion issues.  It has gotten worse. It could be allergies. I don't know if it is allergies. I don't know where it came from. I saw my primary care in 11/2021, doctor and they gave me Z-pak. I went to my ENT doctor as well on 11/19/2021. I don't feel like I should be getting these Z-pak this often. Now I am trying to go to a lung specialist because I am having problems with my breathing and congestion. I had Turbinate surgery in 1/2022. I got COVID-19 in early 2021 and 8/27/2022.
PT REPORTS FEELING LIGHTHEADED,DIZZY,NAUSEA AND SWEATY. NOTED TO BE DIAPHOREETIC AND PALE. DENIES SOB, DYSPNEA OR ITCHING. PATIENT IS ON THYROID MEDICATION AND TOOK  A DOSE IN THE MORNING VS; O2 SAT 97%  HR 83  PT ENCOURAGED TO LAY FLAT W FEET RAISE. ENCOURAGED TO DRINK WATER AND EAT BEFOR COMING TO THE NEXT APPT. PT HAD NOT EATING BEFORE COMING THIS MORNING.  PATIENT FELT BETTER AFTER A CULE OF MINUTE. PT INSTRUCTED TO NOTIFY OBSERVATION TEAM IF SYMPTOMS WORSEN
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
2 episodes of L facial drooping since 730 am this morning.  Episodes last about 30 seconds, pt gets glazed over look in eyes and becomes lethargic. Outside of these episodes pt is awake, running around and playing normally.
Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) and I just stopped.  He tried waking me and I didn't wake right away.  He got up, turned on the light, noticed that I had wet the bed and he continued to shake me and called my name several times, then I opened my eyes.  My speech was a bit slurred at first, I got out of bed, felt nauseous, and my ears were ringing very loudly.  I sat up for a while, then went back to bed.  I didn't connect it to the vaccine, but wondered about the connection.  Then I heard it happened to someone else, so I thought I should report it.  I did not seek medical care.
Sore injection site, muscle ache, head ache, stomach ache, low energy.
PATIENT PRESENTED TO PHARMACY ON 09/05/15 AND STATED ON THE EVENING OF HER IMMUNIZATION AT OR AROUND 9 P.M. PT. EXPERIENCED ITCHY, IRRITABLE EYES AND DESCRIBED FEELING A "FILM" OVER THE EYES AND HAD "MUCOUS" IN CORNERS OF BOTH EYES. PT. ALSO STATED THAT THIS HAPPENED TO HER IN THE LATE 80'S OR EARLY 90'S AFTER RECEIVING A FLU SHOT.
Starting last eve, pt's L upper arm became very sore. Upper arm is now red, swollen and warm to the touch and feels hard from her elbow up to her shoulder.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
PMHx of Alzehimer ds, CVA and dysphagia , HTN presented w/ AMS per Ag Rhods, Per EMS  tachypnic & placed oxygen for comfort, on arrival to ED, alert but tachypnic and diaphoretic, 3 L NC oxygen. Patient is admitted with Sepsis 2/2 urosepsis vs osteomyelitis of the left forefoot + AKI + Abbot positive COVID PNA patient's son decided his mother should not get surgical intervention and he relayed she wouldn't want aggressive treatment and placed patient on hospice through SNF Death: CARDIAC ARREST, END STAGE ALZHEIMER'S DISEASE, DEMENTIA, SEPSIS
Narrative:  Injection site pain and fatigue for 3 days. Myalgia fatigue
sore throat; little bit of a cold; This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASOPHARYNGITIS (little bit of a cold) outcome was unknown. Not Provided      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.   Patient also experienced events don't feel sick and symptoms started 2 days ago. No relevant concomitant medications were reported. No treatment information was provided.
Flumist given when expired - no treatment needed - no adverse effects. Dad was notified and chose not to revaccinate.
Swelling and pain in the left supraclavicular lymph nodes (still present a week later); fatigue (lasted about a day).