chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling tongue; Bruising injection site; Bruising on shin; facial paresthesia; dysphonia; runny nose; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 13-Apr-2021, the patient experienced PARAESTHESIA (facial paresthesia). In April 2021, the patient experienced DYSPHONIA (dysphonia) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site) and PERIPHERAL SWELLING (Bruising on shin). At the time of the report, PARAESTHESIA ORAL (Tingling tongue), INJECTION SITE BRUISING (Bruising injection site), PERIPHERAL SWELLING (Bruising on shin), DYSPHONIA (dysphonia), RHINORRHOEA (runny nose) and PARAESTHESIA (facial paresthesia) 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 concomitant and treatment medications were provided by reporter.   Reporter did not allow further contact
I have a swooshing sound in my left ear since two days after my first dose of Moderna.
One day after booster, experienced significant aching pain in upper spine and left shoulder blade bone, with "cracking" and "crunching" noises and stiffness. Over next day pain expanded to left shoulder joint and left elbow and forearm. Day 3 this pain continued and also experienced pain and stiffness in neck and back of head, left lower side. Pain remained as a very bad ache, and also began to exist in other parts of the body with periodic aches in knees and calves, right cheekbone, right hip, and minor headaches, all of which came and went over the course of 6 days. Pain in back, shoulder blades shoulder and neck lasted approximately 14 days, progressively feeling better days 11-14. Day 15 much better. I had experienced this same shoulder pain 5 years prior, and on and off before that while playing beach volleyball, and attributed it to some kind of sports related arthritis. However, I changed my diet to an anti-inflammatory diet and had not experienced it since 2017.   I did not have this pain with Vaccine dose 1 or 2. Only after the booster.
Woke up on 5/24/2023 at 7:00 a.m. with minor pain and almost a tingling on areas of right scalp and right side of face/ear. Then about 12:00 p.m. on 5/24/2023 experienced dizziness/vertigo, which passed after a couple minutes, then had fever of 100.4 F. around 2:00-3:00 p.m. Took 2 ibuprofen for fever. Felt very tired and lethargic. Slept off and on most of the afternoon. Took more ibuprofen and went to sleep at 9:00 p.m. Woke up about 7:00 a.m. on 5/25/2023 to blister patch size of a nickel on right side of chin and a large blister on scalp above right ear, and rim of right ear very sensitive.  the blisters burn/tingle and painful to touch. Also lymph nodes/glands in front of right ear and below right jaw obviously swollen and sore.  As of 5/26/2023 still have temperature of 100 degrees F.
This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 31-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M043836, expiration date 17-JUN-2018, orally (dose was not reported) for prophylaxis. No adverse effects were reported.
PER PATIENT'S FAMILY, PATIENT C/O TINGLING ON LOWER EXTREMITIES AND BEING VERY WEAK.  FAMILY CALLED DOCTOR OFFICE TO REPORT REACTIONS ON JULY 31, 2009
One day post vax, the pt experienced a fever of 103 and saw an MD in the office. The pt was dx with clinical pneumonia. Presented to the hospital with febrile seizures, and otitis media. Was seen daily for 3 days and was treated with antibiotics.
Patient states began having a dry cough on 3/9/15. She went to her private physician who gave her a cough medicine with codeine.  On 3/10/15, she began having hives (welp-like and patchy), headaches, fatigue, diarrhea, joint pain, hip pain, and sweating. She went to the ER on the evening of 3/10/15.  She was told at the ER that it was not an allergic reaction to the cough medicine but they didn't know what was wrong. They gave her a Medrol Dose pack.  Her symptoms persist and she is going to see the doctor today due to persistent rash and fatigue.
EXPIRED IMMUNIZATION ADMINISTERED-NO ADVERSE SIGNS/SYMPTOMS REPORTED WHEN PATIENT CALLED BACK ON 07/07/2016.
I have had gastrointestinal issues since the day after relieving the shot, I spent the night in the ER because of it 2 days ago. For 3 weeks I have not been able to eat without being in excruciating pain.
It was reported that an 18 month old female was vaccinated on 11/22/99. On 11/23/99, the pt had generalized hives without respiratory involvement. From correspondence received on 2/15/00, it was reported that the pt recovered from this experience. Additional vaccine and responsible physician information was also provided.
Intense debilitating pain in left shoulder/upper arm ever since the injection. Treatment: MOBIC (meloxicam) 7.5mg 1-2 tablets daily with food. Theragesic cream to the affected area. Warm moist heat. Apply for 20 minutes 3-4 times per day.
Extremely sick feeling, dizzy and seeing stars/everything fuzzy for a short period of time, urge to throw up, dry heaving, burning sense in the face.
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs and 9.3 oz. The patient had 1 sister and 1 brother. Concomitant therapy included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).   On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at left thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524:MSD US-009507513-2206USA007508:MSD US-009507513-2206USA007509:MSD US-009507513-2206USA007510:MSD US-009507513-2206USA007511:MSD US-009507513-2206USA007512:MSD US-009507513-2206USA001254:MSD
It felt as though my heart was beating in my throat for about 30 seconds. I continued to get this heart fluttering feeling high up near my throat for next two days 1/8/21 and 1/9/21 for about 2-3 second at a time approx 6x total.  I also got dizzy on 1/9/21 which lasted for about 30 minutes.
I woke up with lightheaded faintness and could barely walk, I was directed to go to ED. BP standing was 80/117. Have seen multiple specialists including Cardiology, ENT, Neurology, and Neuro therapy. No testing has shown any results as to why this is occuring. The closest diagnosis has been PPPD which i am undergoing therapy for with little success. My blood pressure has remained under 90 systolic and I am unable to walk fast, bend my head backwards or forwards, can no longer drive or go to the store, have increased anxiety, confusion, inability to read, off balance and unsteady at most times. Going out for short times exhausts my energy for days.
PTS WIFE NSTATES NPT REFUSED TO GO TO HOSPITAL AFTER DEVELOPING CHILLS, LOW BODY TEMP @ 95, VOMITING, FATIGUE, WEAKNESS, AND LOSS OF APPETITE. SHE FED HIM CHICKEN NOODLE SOUP, PENTY OF BLANKETS, AND GATORADE. ITS BEEN 1 WEEK AND HE IS STILL ILL AND STILL REFUSING MEDICAL ATTENTION
Pt reports large area of swelling, bruising, some rash and extreme pain in area of injection. Painful for approx. 2 weeks. Described by pt as an area approx. 6" in diameter. Still a small area of discoloration on 8/24/2000.
little burning on arm; little soreness on arm; Very red hot square at the injection site; very red hot square at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (little burning on arm), PAIN IN EXTREMITY (little soreness on arm), VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Complex regional pain syndrome.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BURNING SENSATION (little burning on arm), PAIN IN EXTREMITY (little soreness on arm), VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (little burning on arm) and PAIN IN EXTREMITY (little soreness on arm) outcome was unknown and VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site) had resolved.        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 concomitant product was reported.  Treatment drug include Tylenol before bed the same day of the injection for the symptoms and took compounded cream with Ketamine for her knee.
After administration patient was sitting in post vaccination chair and was passing in and out, sweating very much, pale, high blood pressure, and experienced dizziness and tunnel vision.  after about 30 mins patient  was feeling much better.
Shock-like feeling in left upper back region, happened a few times today (9/28) the date after vaccination
rash initially on 30MAR96 on trunk, neck, legs progressive;no fever;seen in office;
received 3 doses of Shingrix; This case was reported by a pharmacist and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020) and Shingrix (received 2nd dose in November 2020).   In March 2021, the patient received the 3rd dose of Shingrix. In March 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported but the patient was over 60 years at the time of reporting. The pharmacist was looking for guidance because the patient received 3rd dose of Shingrix vaccine which led to extra dose administered. No information was provided about lot number or expiration date. Patient was not immunocompromised. Pharmacist mentioned that this situation was already reported. The reported did not consent to follow-up.
L arm became swollen, red, and painful. 5/9/2012 reports to clinic with c/o swollen, red, painful arm. L arm SQ injection site red, swollen, warm to touch, with darker red, raised center approx. 2 in x 0.5 in. L arm IM site slightly swollen and red. R arm SQ site slightly red. Mom reports using OTC pain reliever and cool compresses without much relief. Advised to see MD. 5/16/2012 f/u call made to mother. She reports MD prescribed Keflex. Before keflex had been started child c/o "itchy feet" and mom noticed "welts" on bottom of feet. Child saw MS again. Diagnosed as "hives." Claritin and a topical cream for feet was prescribed. Hives resolved in a couple of days. Reports little change to L arm. Site still red and swollen, raised area in center looks "red/purple, almost bruised like" not as tender. R arm is "fine" Denies any difficulty with breathing.
Due to my extreme allergies I waited at the facility for 30 minutes.  Before the 30 minutes were over my lips began to swell and my eyes began to itch.   I told the facility but did leave to go back to work.  I immediately took Benadryl once returning to work and kept my epi-pens on my desk.  I messaged my allergist through my digital chart regarding the situation for advise.
Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediately after the injection, lasting about 15 minutes
No adverse effects were reported.; a patient was inadvertently administered with one expired dose of VAQTA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-APR-2019 the patient was inadvertently vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 (units not provided) (route unknown; lot#R006471, expiration date was 02-APR-2019) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) involved.
gave expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received dose of Twinrix that was already expired on 28th February 2022, which led to expired vaccine used. The reporter enquired that what he/she need to tell a patient as he/she gave an expired Twinrix vaccine. The reporter consented to follow up via postal.
Swelling and redness at injection sight the size off the vaccine fluid injection. Over the next 12 hours swelling continued to increase at injection site (IS) to the size of 2inches also starting to get low grade heat radiating at (IS). Slight muscle aches all over body. Over the next 12 hours muscle pain increases especially in whole back. (IS) starting to be painful to the touch and difficult to use arm without moderate pain. Over the next 12 hours swelling at (IS) increased to 3inches heat radiating and extreme pain with limited to no movement. Body pain increased to extreme muscle and joint pain all over whole body. Extreme fatigue, nausea, headache and slight blurred vision. These symptoms continued for 12 hours. Over the next 12 hours swelling at (IS) increased in size to 4inches in diameter with heat radiating and limited movement ability.
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0169), in left arm, on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Known allergies: cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Negative, notes: Had two negative at home tests on 13Jul2022 and 14Jul2022; (14Jul2022) Negative, notes: Had two negative at home tests on 13Jul2022 and 14Jul2022; (16Jul2022) Positive, notes: Positive test occurred on 16Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Rebound symptoms beginning 6 days after completing Paxlovid treatment. Had two negative at home tests on 13Jul2022 and 14Jul2022. Symptoms increased and positive test occurred on 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In July I noticed that I was having problems taking off my pants.  Before I saw the doctor, I noticed that my feet were swollen.  There was no pain associated with this.  I was having tendonitis in my right shoulder at the same time.  I was worried it was something with my thyroid.  We did labs and the doc said my thyroid was fine.  He did give me some prednisone for my shoulder which relieved my shoulder pain.  The swelling in my feet also went away.  We have no idea what the issue was.
About 30 minutes after injection of Hep B, patient went into respiratory distress and needed IV fluids, oxygen, and seapap treatment.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days; Patient received 4 doses of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy and HIV disease. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), EZETIMIBE, HYDROCHLOROTHIAZIDE, LOSARTAN and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days), PRODUCT STORAGE ERROR (administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days) and EXTRA DOSE ADMINISTERED (Patient received 4 doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was reported as rosuvastatin.  It was reported that, all the patients had a clinical history of HIV, and all of them were under treatment for this illness.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-476392 (Patient Link).
02/14/23 presents to ED for "shortness of breath". PMHx of "chronic atrial fibrillation on anticoagulation with Eliquis, comorbidities also include essential thrombocythemia essential hypertension coronary artery disease hyperlipidemia"
From initial information received on 16Jul04 from a health care professional regarding an adverse event occurring it was reported that a four month old male pt received his second dose of ACTHIB, lot number X0689; a second dose of DAPTACEL, lot number C1663AA, a second dose of IPOL, lot number X0772; and a second dose of Prevnar, lot number 495302, administered on 15Jul04. The routes and sites of administration were not reported. Within one hour of receiving the vaccines, the pt began to cry uncontrollably and became irritable for approx three hours straight. The reporter denied fever or any local reactions. The pt has no known allergies. The pt's recovery status was not reported.
the clinic did not administer the second COVID vaccine; hives; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (the clinic did not administer the second COVID vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the clinic did not administer the second COVID vaccine). On 13-Mar-2021, URTICARIA (hives) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (the clinic did not administer the second COVID vaccine) had resolved. Not Provided      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.   Concomitant drugs are not provided. Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Added event information