chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema, swelling, induration, tenderness measuring 18 cm x 15.5 cm from left deltoid inferiorly down and laterally. No hives, wheezing, or difficulty breathing.  Treatment: ice, antihistamine, elevation.
Rash on left leg itching. No fever or joint swelling. (+) blanching/pruritic erythematous papular rash to LLE with some excoriation from scratching.
Pt phoned on 3/1/06 to discuss lab results- At that time pt stated a day after receiving vaccines her left upper arm at injection sites became swollen, itchy, and sore with a reddened area approx 8 inches. She felt "A little Down" that day. Did not take temperature. Symptoms resolved after a day or two.
At first I had only a sore arm, felt tired and had a slight fever which dissippated after 24 hours.  I noticed shortness of breath and swelling of my hands, feet and legs 3/31/2021 but was thinking it was due to stress so I ignored it and my symptoms got increasingly worse over the next couple of months and due to feeling alarmingly dizzy and nauseous 6/9/2021 I went to immediate care.  I was then referred to a cardiologist who I saw 6/11/2021 due to an extremely low heart rate and edema in my hands, legs and feet and after an EKG and assessment determined that my heart was healthy and suggested that I "give this time to go away on its own".   Due to continued symptoms I saw a general practitioner at who did a full blood panel and concluded that I was otherwise healthy and attributed my symptoms to "aging" and suggested a low sodium diet.
Blood Clots in Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood Clots in Lung) in a male patient of an unknown age 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) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (Blood Clots in Lung) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (a quarter of lungs removed) for Thrombosis. At the time of the report, THROMBOSIS (Blood Clots in Lung) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided.  Treatment medication were not reported.  The patient was in stable condition since he released from the hospital.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
I experienced achiness and tired and took a long nap. By the next day I felt fine.
No Symptoms. Gave Tdap instead of DTaP. The boxes are very similar. I checked the vaccine bottle label. I administered the Tdap. This is the 4th dose. Found the error when entering vaccines into the MOHSAIC system.
Extreme Joint Pain beginning approximately 12 hours after the injection. Joint pain did not subside until 03/11/2021. Treated by alternating ibuprofen, and Tylenol, heating pads, and rest. Was unable to work for 3 days (Days 3-5). Would not have worked Day 2, but it was a Sunday. Called medical provider on Day 4. Was advised to continue with ibuprofen and Tylenol, and continue to rest.
Shortness of breath. Was not made aware of reaction until mother submitted a survey/feedback. I opened and read the feedback this evening.
Passed out; Arm is still sore; 102°F fever; This spontaneous case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 in November.) in November 2020.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Concomitant medications was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a newborn 2 day old white female who on 12 JUL 2001 was vaccinated with a dose of hepatitis B vaccine recombinant (yeast) (Lot # 640031/0411L). Within one hour of being injected the patient developed "bumps" all over her body that looked like mosquito bites on her arms and one hour later the "bumps" disappeared. The physician reported that the patient recovered and that her experience was non-serious. Additional information is not expected.
After vax pt devel induration inject site. Induration resolved. 3 days later pt devel axillary lymphadenopathy inj arm.
pt became very dizzy a few minutes after receiving vaccine. someone was called to come pick her up she was walked to her ride
Headache, Tachycardia, SHORTNESS OF BREATH, HR 108, O2 SAT 100%. RESPIRATORY RATE 20. Narrative:
Covid Arm. Red area around the spot of the injection. About 4 inches high, 3 inches wide.
11/05/21 The patient presents with shortness of breath x 10 days. was here last Wednesday for pneumonia but denies any relief. He has decreased appetite and been dry heaving. He states he has loose stool. Son in law states the last couple days he is a lot more winded when he talks. It seemed like he was getting better but he got progressively worse. Pt denies noticing his legs being swollen. Pt was given 2 different type of antibiotics but denies any relief. Pt reports he is seeing his doctor on Monday. Pt uses 2 canes to get around. Pt is on Eliquis. Pt is vaccinated for COVID..  The onset was 10  days ago.
VanishPoint syringe malfunction resulting in loss of more than half the dose.  Patient understood and re-vaccinated without incident.
FELT VERY WEAK AND FLUISH, BODY ACHES NOT A GOOD NIGHTS SLEEP. FELT BETTER BY NOON ON THE 26TH
Pt called to report general body aches & fever 103 for 24hrs p/immun;
Nerve pain in both legs (had this pain before but it was retriggered by the vaccine.  As all the other side effects subsided so did the nerve pain.  Additionally, a cough started around the same that has gotten better since the other side effects have subsided however it still remains present right now.    Other side effects I had; fever, chills, nausea, vomiting, body aches, terrible headache
Nonstop nosebleed & vaginal bleeding between periods. Nose blood is not clotting
Tinnitus; A little bit of blood when he blew his nose; Bleeding gums; Shakes; Aches; Fever (99.7 degrees Fahrenheit); loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (99.7 degrees Fahrenheit)), PAIN (Aches), EPISTAXIS (A little bit of blood when he blew his nose), GINGIVAL BLEEDING (Bleeding gums) and TREMOR (Shakes) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Factor V Leiden carrier (Discovered with Pulmonary Embolism) on 15-Apr-2021, Penicillin allergy, Thrombophlebitis on 13-Jun-2012, Osteoarthritis knee on 10-Jul-2017, Posterior vitreous detachment on 27-Nov-2018 and Tinnitus (Worsened on or about April 29 2021) since 15-Apr-2006. Concomitant products included RIVAROXABAN (XARELTO) from 01-Aug-2019 to an unknown date for Factor V Leiden mutation, COLECALCIFEROL (D3 50) from 01-Jan-2021 to an unknown date and MULTIVITAMINS [VITAMINS NOS] from 01-May-2002 to an unknown date for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever (99.7 degrees Fahrenheit)), PAIN (Aches) and TREMOR (Shakes). In February 2021, the patient experienced ANOSMIA (loss of smell). On 18-Feb-2021, the patient experienced EPISTAXIS (A little bit of blood when he blew his nose) and GINGIVAL BLEEDING (Bleeding gums). On 29-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 16-Feb-2021, PYREXIA (Fever (99.7 degrees Fahrenheit)), PAIN (Aches) and TREMOR (Shakes) had resolved. On 18-Feb-2021, EPISTAXIS (A little bit of blood when he blew his nose) and GINGIVAL BLEEDING (Bleeding gums) had resolved. At the time of the report, TINNITUS (Tinnitus) and ANOSMIA (loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 15-Feb-2021, Body temperature: 37.6 (High) (99.7 degrees Fahrenheit).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received and contains updated concomitant medications RIVAROXABAN 10 mg daily for Factor V Leiden, added events- Tinnitus, Anosmia, updated outcome for events - Epistaxis, Gingival bleeding as recovered. On 31-Jul-2021: Follow up received and  contains no new information . On 02-Aug-2021: Follow up received and contain Lab results updated.
symptoms starting to show around May and I noticed more in the summer, I finally had to see a Dr. about the ringing in my left ear which she said I have tinnitus. I have never had ringing in my ear till after the vaccine and now I am stuck with ringing in my ear.
Pfizer Covid vaccine that had been in refrigerator was administered on day 33 in refrigerator instead of manufacturer limit of 31 days. Patient was offered revaccination. And proper labeling of vaccines has been enforced.
Awoke day after immunization feeling feverish, sore arm with warmth, three loose bowel movements so far today, nausea, fatigue and had to miss work today as well as tomorrow.  Took acetaminophen with mild improvement in fever and pain.
This spontaneous report as received from a registered nurse refers to a 72 year old male patient. The patient's medical history and current conditions are not reported. On 15-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 01-SEP-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During August of 2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse via Medical Record refers to a currently 4 year old male patient with no known drug allergies (NKDA). On 23-JAN-2010, the patient was vaccinated with the first dose of hepatitis B virus vaccine (unspecified) for Hep B. On 16-APR-2010, the patient was vaccinated with the first dose of PENTACEL for DTP/aP; First dose of pneumococcal vaccine (unspecified) for PCV. On 16-APR-2010, the patient was vaccinated with the second dose of hepatitis B virus vaccine unspecified) for Hep B; first dose of pneumococcal vaccine (unspecified) for PCV. On 16-JUN-2010, the patient was vaccinated with the second dose of PENTACEL for DTP/aP.On 10-AUG-2010, the patient was vaccinated with the third dose of PENTACEL for DTP/aP; Third dose of pneumococcal vaccine (unspecified) for PCV. On 20-OCT-2010, the patient was vaccinated with the third dose of hepatitis B virus vaccine (unspecified) for Hep B, First dose of influenza virus vaccine (unspecified) for influenza. On 20-NOV-2010, the patient was vaccinated with the second dose of influenza vaccine (unspecified) for influenza. On 21-JAN-2011, the patient was vaccinated with the first dose of hepatitis A virus vaccine (unspecified) for Hep A; Fourth dose of PREVNAR 13 for PCV. On 05-MAY-2011, the patient was vaccinated with the first dose of M-M-R II for measles. On 26-AUG-2011, the patient was vaccinated with the fourth dose of PENTACEL; Second dose of hepatitis A virus vaccine (unspecified) for Hep A; Booster dose of influenza virus vaccine (unspecified) for influenza. On 06-DEC-2011, the patient was vaccinated with the fourth dose of PENTACEL. On 14-MAR-2014 at 02:17:07 pm, the patient was vaccinated with the second dose of PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the fifth dose of DAPTACEL; Fourth dose of IPOL and VARIVAX (Merck) (lot# and route not reported). This is one of several reports from the same source.
Had seizure following 1st dose of GARDASIL, hep a & INFLUENZA.
48 hours after receiving first dose of Engerix B, the pt developed swollen eyelids. The pt recovered. One month later the pt received the second dose of Engerix B. Subsequently, he experienced severe itching on the bottom of his feet. Additionally he had a hematoma at the injection site. He was treated with Benadryl on 09/27/1999. The most recent information received reports the condition of the pt is unknown.
4/22/2023 - 5/22/2023 (30 days)   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxemia (HCC)    HOSPITAL COURSE: Patient is an 80 y/o male with a PMHx of HTN, BPH (self-caths), dyslipidemia and LUE melanoma s/p resection, followed by Dr. of oncology, previously on Keytruda. He was recently hospitalized at BW from 4/10-4/17 for AKI and acute liver failure with liver bx secondary c/w DILI secondary to Keytruda. Patient was started on prednisone with subsequent improvement in LFTs and renal function, and was discharged home on a planned 7 day course of prednisone 70 mg daily. He presented back to the hospital on 4/22 with SOB, weakness and maroon stools. In the ED he was found to be hypotensive and was started on norepi after receiving 2 L IVF. Also placed on BiPAP for hypoxemia. Labs signficant for AKI, elevated LFTs, elevated troponins, lactic acidosis, leukocytosis and anemia with Hgb 5.9 (Hgb was 8.2 on 4/17). UA with pyuria and quad panel (+) for COVID. CTA of chest was negative for PE and showed moderate emphysematous changes, bilateral upper and lower airspace disease and small pleural effusions. He was admitted to the ICU.    He received 2 units PRBC and GI was consulted. They recommended EGD once respiratory status improved. He was able to wean off pressors and was transferred out of ICU 4/23. He was started on antibiotics to cover possible superimposed bacterial infection due to recent hospitalization.  Gastroenterology team deferred to oncology to manage steroids for DILI.  Oncology recommended tapering steroids to 40 mg daily at discharge and outpatient follow-up with oncology. Due to worsening respiratory status CT angiogram of the thorax and bilateral lower extremity venous duplexes were repeated which showed bilateral PEs and DVTs.  Patient was started on heparin drip.  While on heparin drip patient had drop in hemoglobin and received multiple units of blood transfusion.  Patient underwent EGD on 5/7/2023 which showed a duodenal 1 cm clean based ulcer without high risk stigmata (likely etiology for GI bleeding). He was continued on PPI BID with recommendations to continue for 8 weeks, then daily. He was restarted on heparin gtt and tolerated. He was transitioned to Eliquis. He briefly required high-flow nasal cannula which was slowly weaned off to nasal cannula with oxymizer. He remained stable on this for several days and oxygen was weaned further. He was seen by pulm rehab for home oxygen needs. Pulm rehab recommended 4 liters/minutes at rest and 6 liters/minute be O2 dependent   He was seen by PT/OT who recommended home with assist, home health and therapies.   Patient was discharged home in medically stable condition.
Unconsolable high pitched screams/cry 11:00AM-5:00PM day of vaccines.  Sore right upper thigh.  Tender to touch with multi swelling but no induration, no redness.
I had a lapse of memory and was told that I repeated words three times, consistently for approximately ten minutes; This is a spontaneous report from a contactable other hcp. A 68-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:00 (at the age of 68-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included coronary artery disease (CAD) and diabetes. Allergies to medications, food, or other products was reported as NKDA. The patient had received other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received BNT162B2 for covid-19 immunization on 13Jan2021. The patient experienced a lapse of memory and was told that she repeated words three times, consistently for approximately ten minutes on 04Feb2021 at 12:00 pm. No treatment was provided for the events. The event was not serious, and it did not cause life threatening or fatal outcome. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
consumer reports that child reacted to DTP shots which were recvd when pt was 4 & 6 months old; sxs unspecified @ 18mos of age, pt recvd DTAP w/no adverse event reported;pt h/o various allergies to medicines;
severe ache in left arm x 48 hours with fatigue. nausea, body aches, fever/chills x  72 hours
no additional AEs reported; Caller reported 30 year old female received 1st GARDASIL 9 in 2007 and received 2nd GARDASIL 9 vaccine on 10/15/2022.  Lot number and expiration date documented for 2nd dose.  Information for 1st dose is unknown.   No other information provided.  No; This spontaneous report was received from a pharmacist and refers to a 30-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in 2007, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot #, and expiration date were not reported) and on 15-OCT-2022, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered intramuscularly, lot # U019412 confirmed to be valid for formulation syringe, expiration date 30-OCT-2023 (anatomical location was not reported), both for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who was vaccinated with an expired dose of ACT-HIB lot number not reported via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
always get the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves a patient of unknown demographics who always got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she always got the flu (influenza) 7 to 10 days after the patient got the Influenza vaccine.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Excruciating pain all over body (most pain I have ever felt in my life), stiffness and restlessness, terrible headache, diarrhea, vomiting, weakness, freezing all over
Breakthrough case admission after 3 vaccines Pfizer 3/12/21 Lot# EN6199;  Pfizer 4/5/21 Lot# Er8733;  Pfizer 11/1/21 Lot# 30125BA
Symptoms:  Lightheadedness/dizziness; Nausea; Ringing in ears Metallic taste Symptoms got progressively worse from onset until approximately 12/23/2021, at which time the dizziness and nausea abated significantly.  Metallic taste disappeared on/around 12/26/2021.  Ringing in ears has remained at same level until this report date. Treatment:  My PCP evaluated ear canals but saw no sign of infection/inflammation.  He prescribed a course of Methypredisolone, which I took but noticed no change.  I then saw an ENT, which performed further evaluations, but noted no signs of infection, no hearing loss of concern nor any pressure readings of concern.
chills, fever, aches, rapid heartbeat at times on 4/18/2021 evening, headache, tiredness
Her upper lip swelled about an hour and a half after she was vaccinated. He was with his swollen lip until the other day. Benadryl was given every 6 hours, zyrtec twice a day, and pepcid. She also got a fever at night