chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that she started a high fever on Saturday night (9/28) that continued through Tuesday(10/2). She also stated injection site pain that was hot to the touch. She stated to have a red area that was approximately 7 inches by 4inches. She stated that her kidneys were hurting. She went to her doctor today(10/2) and they started her on antibiotics.
pt had a positive COVID test 1/4/22; 3/29/22 pt to ED with c/o dry cough, SOB, chest pain; found to have pulmonary edema; elevated tropins; ejection fraction 15-20%; multiple intracardiac thrombi; suffered cardiac arrest multiple times with ROSC achieved; pt continued to decline; became a DNR; pt went into asystole, and passed away in the hospital
Developed vitiligo approximately 2-3 months after taking my 1st and 2nd dose of the Pfizer vaccine.
This spontaneous report was received from a pharmacy technician who referred to a 65 years old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2017 (reported as 31-OCT-2017 or 15-NOV-2017), the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly, lot # N013521, expiration date 23-JAN-2019 (dose was not reported) for prophylaxis. On 17-NOV-2017, the patient came to the pharmacist in pharmacy and reported that he experienced "redness and swelling down the unspecified arm that he received the PNEUMOVAX 23 in". No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The reporter requested a lot check for lot N013521 of PNEUMOVAX 23. Sender's Comments: US-009507513-1711USA007973.
pt recvd vax & 60-90 minutes later pt devel nausea, chills, h/a, hyperventilation; 5 hrs p/inject pt exp vomiting, numbness in the hands in a glove distribution, loss of consciousness; pt was adm to ICU;
Awoke to room spinning; Nausea with neck flexion; This is a spontaneous report from a contactable nurse, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 07May2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and allergies to dried fruit preservatives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medication. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 at 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 07:00, (also reported as 36 hours after dose), the patient awoke to room spinning in the morning (reported as AM) did not stop for 8 hours and the patient also experienced nausea with neck flexion and spinning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events awoke to room spinning and nausea with neck flexion was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
suspected vaccination failure; got the shingles the next year, twice, but a mild case of it; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingles vaccine one year nad 2nd dose of Shingles vaccine next year and got the shingles the next year, twice but a mild case of it. The reporter said still would get the shot if they have another on available and was worth it. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown.
States became noticed a few hives, became nauseated, lightheaded, lips became numb. She put cold compress on her head, layed down and symptoms, except for hives subsided after approx. 7 min. On 10/05/2012, in PM, states hives began to worsen, with itching.
Pt had walked to the lobby from the vaccination room and was sitting in a chair with his mask on.  Five minutes after his injection with the COVID-19 vaccine he felt hot, nauseated, vomited a small amount of yellow emesis twice and became pale.  He continued to sit up in the chair and a cool cloth was placed on the back on his neck and a fan was turned on.   He was alert throughout.  His BP was checked 4 minutes after the event and read 92/60 with a pulse of 74.  He denied feeling lightheaded.  He sat in the lobby with father by side and health department nurses monitoring him for 30 minutes.  After the 30 minutes pt gets up out of chair without difficulty and ambulates around the lobby with steady gait and denies lightheadedness, nausea/vomiting or shortness of breath.  Leaves accompanied by father.  Encouraged to push fluid, stay out of the heat today and to take it easy the rest of the day.   Checked on pt by phone through the father and he related that pt was feeling much better, denies symptoms.
Severe pain where the shot was given. Unable to raise arm, unable to sleep on the left arm. 05/26 Fever of 101. 3  05/26 Skin sensitive to touch on whole body, restless body, upper back pain.
Nausea. Dizzy/ blacked out. 4 BMs within 1.5 hours (not diarrhea), stomach roiling. Horrible fatigue. Achy body. Mild headache. No fever. I took TYLENOL and that helped with some of the pain symptoms. I am starting to feel better by 5 PM today (1/17/2019). Could not go to my meeting due to feeling so crappy and dizzy.
Achy muscles all over; flu; Headache; Chills; No appetite; This is a spontaneous report from a contactable consumer.  A 67 years old non-pregnant female patient received her first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; lot number: UNKNOWN) via unspecified route of administration at left arm on 24Feb2021 at 11.15am as single dose for COVID 19 immunization. She also received her second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; lot number: UNKNOWN) via unspecified route of administration at right arm on 17Mar2021 at 11.15am as single dose for COVID 19 immunization. The patient was not diagnosed with COVID-19 prior or after the vaccination. Medical history included approximal Atrial fibrillation, GERD hypothyroidism since an unknown date. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN),, Eliquis (MANUFACTURER UNKNOWN), Pantoprazole (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) for an unknown indication since an unspecified date. The patient did not undergo any lab tests or procedure. On 18Mar2021, the patient experienced achy muscles all over like flu, headache chills and no appetite. The did not received any treatment for the events.  The events achy muscles all over like flu, headache chills and no appetite were not resolved at the time of the report. No follow-up attempts are possible; information about lot number cannot be obtained.
Within 12 hours of vaccination, experienced pain in scapular area with tingling radiating down the Left arm with numbness in index and middle finger of same arm.  Pain Tingling and numbness advanced. Visit with Primary Caregiver on 10/1, prescribed Medrol dose pack.  After course of Medrol dose pack, pain was eliminated but tingling & burning & numbness in finger persists.  Also noticed a flare of peripheral neuropathy in toes.  Consulted a Neurologist who requested MR Cervical Spine & MR Neurography of Left Brachial Plexus. At 6-1/2 weeks, arm is starting to have reduced symptoms, but toes have not recovered at all.
Patient described pain and weakness in her left arm and shoulder beginning a few hours after vaccination  and lasting till today (38 days later)! She reported varying severity of pain over this period, with severe pain a few weeks after vaccination, and now less severe pain which she compared to the pain she felt the first week after vaccination. She currently describes the pain as seeming to be in her bicep and radiating up toward her shoulder. She has visited her primary with doctor's office,  told her doctor about the event, and been prescribed a cream to treat the pain. She reported that her doctor said the pain could be from tendonitis or bursitis. Patient reported that the cream has not been working well and that she intends to try other methods. Patient also expressed concern that this pain could be permanent and apprehension about receiving any booster doses in the future.
Initial report received on 16 September 2008 from a healthcare professional. A 31 year old female, with no medical history and who was using Nuvaring, received on 11 September 2008, a left deltoid intramuscular injection of ADACEL (lot number C2768AA). Her last "td" vaccination was in 2000 and adverse event following prior vaccinations was unknown. After an unspecified amount of time on the day of vaccination (11 September 2008), the patient complained of blurred vision, lightheadness and warmth at the injection site. She went to the emergency room. Corrective treatment was not reported. The patient's recovery status was reported as unknown. Follow-up information was received 02 October 2008 from a health care professional who confirmed that the patient had recovered from the event (date of recovery not reported).
An hour and 45 minutes after the shot my face and neck became red with a rash and my heart started racing and I felt dizzy.  I went to the emergency room and my heart rate was in the 160s and my blood pressure was 190/ 102 and I almost fainted.  They gave me  120 MG of IV solumedrol,  50 mg Benadryl  and Pepcid through the IV and IV fluids and said I was having an Allergic reaction to the Moderna shot.  I was sent home with another 40 mg of prednisone and to take 50mg of  Benadryl every 6 hours.  Continued to have after shocks of increased heart rate and feeling faint and getting a rash on my face and chest  every 6 to 12 hours for 3 days.  I continue to have heart palpitations to this day.
Dizziness, Headache, Diarrhea, Injection site pain/swelling, Fatigue Narrative:
Patient is not yet completed 18years of age & got Moderna vaccine. No side effects/ adverse effects occurred
Information has been received from a physician concerning a 10 yr old Asian male with no medical history who on 12Oct98 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant therapy and no illness at the time of vaccination. The physician reported that in March 2005, the pt developed breakthrough. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt was recovering. Follow up information indicated that the child presented in the office on 23Mar05 with papules and vesicles all over the body. There were over 100 lesions and some were in the scabbing stage. The diagnosis was breakthrough varicella with an onset date of 23Mar05. The pt recovered on 30Mar05. The pt's sister (WAES0505USA01974) also developed varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Clint returned approximately 30 minutes after administration complaining of increased redness and burning  on injection site and hands and feet. A cold compress was applied to area and the client was asked to stay for continued observation.  VS- p - 118, B/P - 135/88, SpO2 99%  Client c/o increased itching of palms. Assessed as having generalized anaphylaxis.  Client refused IM or PO Benadryl. Epi pen was administers and EMS activated. Client was transported to  local ER via EMS. Client discloses he has "never had any vaccines in his life."
Patient received Fluzone Quadrivalent standard dose in error instead of Fluzone High Dose due to their ages/ No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via call center via The agency (Reference number- 00334255) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 73 years old female patient who received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot UJ428AA, expiry date not reported] via an intramuscular route at an unknown administration site on 20-Oct-2020 for prophylactic vaccination  in error instead of fluzone high dose (lot number and expiry date not reported) due to their ages (wrong product administered).  Medical history, medical treatments, past vaccinations and family history were not provided.  Patient did not receive any other concomitant vaccines.   It was a case of an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  It was reported that, caller requested one type of flu vaccine (High Dose) and did not get the vaccine.   Product used : Used  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
came in contact with her grandson a week ago Saturday and Monday. Then on Thursday, her grandson tested positive for Covid; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Mar2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on March9 and was scheduled to receive the 2nd dose tomorrow on 06Apr2021. However, she came in contact with her grandson a week ago Saturday and Monday in 2021. Then on Thursday, her grandson tested positive for Covid in 2021. Consumer said she got tested on Friday in 2021, and the results showed negative. she wanted to know if it would be safe for her to receive the 2nd dose. patient also wanted to know how long she should quarantine. patient second dose scheduled more than 21 days. The outcome of event was unknown.  Information about lot/batch number cannot be obtained.
Large bump that takes up majority of deltoid, redness, heat, tingling from shoulder to finger tips.
Jerking head to the side and jerking arm along with face twitching for five minutes.
Patient broke out in fine rash and hives, was having intense itching.  Itching lasted for 2 days.
I had the injection on Thursday afternoon.  Sunday morning I woke up to hives on my body.  The hives persisted and on Tuesday, I had the feeling that my throat was getting tight and my mouth felt swollen.  I went to the urgent care and was given a dose of Prednisone, followed by an Rx for nine more days of a tapering dose of prednisone.  On Tuesday evening, my lips were hot and swollen.  As of today, Thursday, I am still dealing with signficant itching and redness but am able to mostly control it with doses of Benadryl.
hand tremors only in right hand which have increased in intensity since April.   tremors have impacted fine motor skills including writing, eating, carrying a glass, playing guitar and other quality of life concerns.  These have not decreased even with ongoing weekly treatment from Chiropractric & Accupuncture to reduce constant movement of hand XRays of the shoulder/ arm have ruled out orthopedic causes.  Consultation with Neurologists so far has ruled out possible causes such as Parkinson's or vitamin b12 deficiency
little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Levothryroxine, METOPROLOL, VALPROATE SEMISODIUM (DIVALPROEX), CALCITRIOL, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), BIOTIN and CALCIUM CITRATE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (little soreness). At the time of the report, PAIN IN EXTREMITY (little soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment products included ice.   This case was linked to MODERNATX, INC.-MOD-2021-063983 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-063983:case for second dose
Redness and swelling of bilateral upper anterolateral thighs extending to knees. Treatment: intermittent cold compresses, Benadryl cream, Tylenol/Ibuprofen, improved redness/swelling.
No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 26-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335: US-009507513-2202USA003592:
Heavy tongue, pain at injection site, tingling bilaterally in arms. Cleared by EMS
When she was driving home after her vaccination, she started feeling like her lips and tongue were swollen all the way up to her nose. It lasted about 20minutes then it went away and didn?t comeback anymore. Denies any other accompanying symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Shortly after taking the first dose (3 pills in the morning) she threw them up. Patient had uncontrollable coughing and despite trying not to throw up, she had to and she puked most of the medicine. My cough is much worse now than before she took the pills. She drank them with lots of water (almost a full 16 oz) but she don't think they sat well in my throat or stomach. She was still coughing after the throwing up episode whereas before she threw up she wasn't coughing much. Adverse event start date at 27Nov2022 and start time at 02:30 PM. Patient was Recovering. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine. Device Date was 27Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient requested the Pfizer COVID vaccine but received 03ml of the Janssen COVID vaccine instead. No side effects were reported when we let the patient know about the error later that day.
Presented w/ cough, SOB, & fever x 3 days; admitted for COVID-19 pna, tx w/ abx, remdesivir, steroids, & zinc; did not need O2 therapy; dc to home
died after taking a Covid vaccine; This is a spontaneous report. A non-contactable consumer reported that a patient (reporter's cousin) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died after taking a covid vaccine on an unspecified date. This report was reported as non-serous by reporter. The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after taking a Covid vaccine
2 1/2 hours post vaccination temp 99.2 with fatigue. Patient given TYLENOL 500mg, rested and repeat vital signs. Discharged with temp 98.8 B/P decreased to 128/88 from 140/94. Patient discharged home.
Immediately large hives came up close to site of injection on both arms. Doctor listened to lungs and they were clear so they gave Benadryl by mouth and monitored baby for 20 minutes before we left.
CLINICAL IMPRESSION 1. COVID-19 virus infection  2. Bilateral pulmonary embolism  3. Hypoxemia
pt recvd vax; 14 days later pt fell off table; mom could not arouse pt for 4 min;pt was unconscious and when arouse, pt did v and had bowel movement;became very sleepy; dx of sz;