chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours after vaccine, my legs became mottled. My doctor confirmed Livedo Reticularis. No pain swelling or issues, just discolored. It has been visible majority of the day (I am not ?cold? and i wear warm clothes). It has been a week, and has not gone away yet. I also started to get swelling / redness and a lump on my arm exactly 7 days after vaccine was given.
Hospitalization for dyspnea acute on chronic hypoxemic respiratory failure, tachypnea with COPD exacerbation likely due to COVID on dates 3/14/2023-3/17/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
After about five minutes of administering flu vaccine Client started to cry stating her head and neck was hurting. Asked client to have a sit and asked her if she was having a hard time breathing. Client stated no. Client had erythema of her face.
Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific.  Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait.  Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0.   He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated.  As of today, he has had 5 consecutive days of plasmapheresis.  Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3.  Now awake, alert, and oriented.  Eating and ambulating with physical therapy
Information has been received from a health professional concerning a 19 year old female patient who is an employee in the office. It was reported that the patient was practicing the administration of PPD's utilizing "Merck Sterile Water Diluent for Live Virus vaccine" as a placebo. Subsequently the pt developed "an allergic reaction at the injection site." According to the reporter that patient experienced burning, pain and faintness. The pt did not require hospitalization or treatment. The pt pulse oximetry and vitals were normal according to the reporter. Additional information has been requested.
No adverse effects reported; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 12/20/2022.; patient was 15 at the time he was administered PROQUAD; This spontaneous report was received from a healthcare business professional (HBP) (also reported as office manager) referring to a 15 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 20-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 ml, lot # U039261, expiration date 09-JUN-2023; strength and route were not reported) for prophylaxis, which was outside of labeling approved age, and the vaccine had temperature excursion (TE) (product storage error, product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2308USA000495: US-009507513-2308USA000450: US-009507513-2308USA000144: US-009507513-2308USA000469: US-009507513-2308USA000432: US-009507513-2308USA000669: US-009507513-2308USA000185:
R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9 - Pneumonia, unspecified organism
Numbness in feet, severe headaches, nausea, vomiting, stomache aches, shortness of breath 11/23/2009 PCP records for 10/6/2009, patient with c/o's leg pain. no tx noted
Received PPV 23 (Pneumovax) 3-7-07. Seen 3-8-07 with cellulitis below injection site (dorsum of arm swollen, indurated, hot, tender). Treated with Cleocin and Medrol pak and "steroid injection at Urgent Care. T=97.9.
Pt experienced a very edematous and painful injection site and was unable to lift her arm unless using the other arm to do so.
Received COVID Bivalent booster on Tuesday 2/21/23 during annual checkup. The following day (2/22/23) she developed swelling (lemon sized) and burning/ aching pain under her left arm which radiated to her elbow and shoulder. This is the arm in which she received the vaccine. This lasted several days. The swelling gradually improved over several days and resolved on 2/25/23
I have been diagnosed with Gillian barre. I had no feeling in my hands and fingers. Then I had no feeling from my knees down. I went to the ER. Then I had no feeling from the middle of my chest down. They did blood work, MRI, x-ray, lumber puncher, and neuro test. These symptoms are still ongoing as of today and I cannot work.
Passed out; Feeling sweaty; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD.    On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Treatment medication included aspirin and ice pack on injection site.  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.; 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.
Patient started to experience ringing in is right ear several days after getting both vaccines. He states he had had flu shots in the past without issue, so believes the ringing in the ear is due to Shingrix vaccine. He was seen by an ENT ( Ear/Nose/Throat ) physician and a Chiropractor to see if they could help resolve issue of ringing in ear. Both doctors were unable to resolve or make better issue of ringing ear.
administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
RVA given pneumonia on 10/02/2001, localized irritation noted right arm, warm to touch, swollen and tender, hard chills on 10/01/2001. To see PMD 10/02/2001.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 28.52 for dose administered on 03-Apr-2021 . No concomitant medications were reported. On 30-Mar-2021 , the vaccine with batch number 030B21A was moved to fridge. On 31-Mar-2021, 14 vials were moved to the clinic. On 31-Mar-2021 at 9 a.m, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit. On 03-Apr-2021, 20 vials were moved to the clinic. On 03-Apr-2021 at 9 a.m, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 45 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Positive, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 13Feb2023 to 17Feb2023.
I learned that patient was sent to psychiatric hospital and was not able to attend the 2nd dose clinic.  We were not able to give patient her second dose until after the recommended day window.  She received her 2nd dose on 4/7/21.  No further information was disclosed.
2/1/2021 that morning I woke up and my left arm was swollen, a rash from the shoulder halfway down the arm. It was raised and hot to the touch. It was also very sore. The next day, I called the doctor. He had me take BENADRYL and had me put a steroid ointment on it. I stayed I contact with him and it got better after a couple of weeks.
Lymphadenopathy; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lymphadenopathy. Caller stated if it is a reported side effect. Did not wish to provide further demographics. The outcome of the event was reported as unknown.   Information of lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a woman in a doctor's office, a registered pharmacist and a registered nurse, concerning a 78  year old white female who on 10/24/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent in the right deltoid (Lot # 635892/1197K). There was no illness at the time of vaccination. On 10/26/01 (previously reported as within 12 hours of administration of the vaccine), the patient developed an injection site reaction with enlarged , red, hot and painful areas. It was also reported that the patient developed redness and swelling at the injection site, a slight fever and was tired. It was reported that the arm "appears to have reaction similar to cellulitis". The patient was treated with cephalexin (Keflex) (previously reported as ciprofloxacin hydrochloride (CIPRO), acetaminophen (Tylenol) and warm packs. The patient was seen at the physician's office on 10/29/01 and he documented that the injection site was getting better and that the warm packs made the reaction worse. The patient was instructed to use cold packs. It was noted that the patient had since recovered. The pharmacist who supplied the physician's office with the pneumococcal vaccine 23 polyvalent was worried about using the last vial. The records of testing prior to release of this lot (635892/1197K have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected.
7 days after administration developed urticaria, thick tongue, lump in throat, headache, joint pain.
After watching some past videos, I believe my child had a reaction to the MMR vaccine he was given on 12/11/95. By the following December of 1996, we were having his hearing tested, due to an obvious language delay. Within months, we learned he had autism. He was officially dx'd as autistic in 10/98. There was a noticeable difference in behavior by 12/25/95 and we make reference on tape of how sick he had been earlier thus making me believe now, that he had a reaction. 60 day follow-up states the pt still has autism and he has been tested for heavy metals and the level of mercury is 8.
REPORTED REDNESS AND RASH AT INJECTION SITE.  REPORTED FACIAL SWELLING. PT BACK TO OFFICE AT 2:00 PM--NO VISIBLE SYMPTOMS WHEN BACK IN OFFICE.
No additional AE reported; a dose of PNEUMOVAX23 expired on 10/3/2021 and was administered on 10/7/2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 07-OCT-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T021329, expiration date 03-OCT-2021, 0.5 milliliter) for prophylaxis (expired product administered). The vaccine had no previous temperature excursions. No additional adverse event (AE) was reported.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 492 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
At site of MMR developed red, raised, itching ring by next day. Mom gave Tylenol for "low grade" fever and applied Alveeno cream and Hydrocortisone cream. Size of 9cm with white halo around it on 05/14/004. Started to get smaller by 05/15/04. Seen in office 05/17, raised, red, nodule 3.5x3cm, warm.
Pt recvd 2 doses of Hep B vax on 13JUN90 & 17JUL90 approx AUG90 exp bilateral wrist pain, w/pain & heat disseminating to all the joints of body; pt dx has having rxn to vax; MD recommended that pt not recvd 3rd dose;
On June 8, 1999 the pt experienced 50-60 lesions very small behind knees, in crook of elbows and on face. The pt was afebrile. On 6/7/99 she was vaccinated with varicella virus vaccine live. The pt sought unspecified medical treatment. Additional information has been requested.
Temperature; Body aches; Chills; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was provided.
Skin flushing of chest and hands bilaterally, shortness of breath, diaphoresis, numbness of lips.  1/27/2021 at 3:45pm
Information has been received from an employee of the state immunization program regarding 2 patients approximately 12 months old who were vaccinated with MMR. Subsequently, 11-12 days post vaccination, the infants developed a rash. Unspecified medical attention was sought. Additional information has been requested.
redness/swelling/tenderness at injection site: day 7 of injection.   cephalexin 500 QID for 10 days started 06/26/2022
2/14 vaccination 2/14 Evening, I had a HA, severe back ache, chills, fever of 100.3. I was really in so much pain I could barely walk. Lasted for 2 days.  2/16 I went to urgent care. Dr. stated 'normal body just responding to vaccine. You should have waited 3 months to have vaccine'.  2/17 I went back to work. Had severe stomach and back pain. Went to the ER. I had severe stomach infection, abcess in pelvic and I had to go for emergency surgery.  2/25 surgery for emergency colostomy.  *in recovery right now. I go back to have surgery in a month to have things 'reconnected'.  *COVID +; 12/2020 *Medical Center; 3 weeks inpatient  *cannot find vaccine card with Lot ; to cb to VSAFE with #
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Experienced rosacea and acne for the first time in 20 years and disruption in my menstrual cycle.
This spontaneous report as received from a nurse, who worked in the office of a physician's assistant, via a company representative refers to a female patient of unknown age. Information regarding her pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously, as a preventive measure against the herpes zoster virus (the dose, dosage number, anatomical location, lot # and expiration date were unknown). Subsequently, on an unspecified date, the patient developed an injection site reaction which was described in detail but, it was stated that the site was painful to touch. She sought medical attention and received a steroid injection as treatment. The outcome of the events, at the time of reporting, and the causal relationship between the events and the vaccine were unknown. Additional information has been requested.
Patient started to experience swelling, itching, pain. The site of irritation has increased in size and has not decreased in 8 days. Patient was advised to use ibuprofen around the clock and benadryl.  She has continuously been using both with no alleviation. Instructed to consult physician as well and to continue both therapies until further notice.
Information has been received from a pharmacist concerning a 65 year old male who on 26-FEB-2009 was vaccinated with the first dose of PNEUMOVAX (lot n. 661528/0867X).  Concomitant therapy included influenza virus vaccine (unspecified).  The pharmacist reported that the patient experienced soreness and swelling at the injection site 4 hours after administration of his first dose of PNEUMOVAX.  The patient eventually was not able to raise his arm above his head because of pain.  His arm swelled to twice its normal size and became red and warm to touch from injection site area to his elbow.  The patient sought medical attention via telephone.  He had been taking IBUPROFEN and TYLENOL.  The pharmacist stated that the patient receives influenza virus vaccine (unspecified) once a year occasionally has experienced mild swelling at the size of injection.  No labs were performed.  At time of reporting the patient had experienced some improvement with pain and swelling.  Additional information has been requested.
Fever of 100.4 degrees F., Chills, Muscle Pain, whole body Body Aches,  Tiredness, Swollen Lymph Nodes on Left Armpit, Excessive Muscle pain & Body ache on Lower portion of Neck, Left Shoulder, Entirety of Left Arm (including upper arm, lower arm, wrist, upper hand & palm, and fingers).