chrisvoncsefalvay/vaers-outcomes huggingface dataset:
recvd vax;eve devel severe pain in back;could not move/walk;devel intermittent numbness of legs,feet;devel flu like sx w/ T 103-104;2 days later,to MD who tx w/ motrin,muscle relaxants;pos HLA;MD dx ankylosing spondylitis;unrelated to vax;
Cerebrovascular accident; Hemiparesis; Neurological symptom; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and HEMIPARESIS (Hemiparesis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     There is no relevant medical history reported.  Concurrent medical conditions included Penicillin allergy. Concomitant products included VENLAFAXINE, FINASTERIDE, TRAMADOL, PARACETAMOL (TYLENOL), ASA, CYCLOBENZAPRINE, ALPRAZOLAM, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), MULTIVITAMIN [VITAMINS NOS], FISH OIL, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), NAPROXEN SODIUM (ALEVE) and OMEPRAZOLE for an unknown indication.   On 24-Feb-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) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion medically significant), HEMIPARESIS (Hemiparesis) (seriousness criterion medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident), HEMIPARESIS (Hemiparesis) and NEUROLOGICAL SYMPTOM (Neurological symptom) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Magnetic resonance imaging: light stroke but dissolved by itself.. On 24-Feb-2021, Ultrasound Doppler: unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.  Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Mother reported Fever 104-105F, rolled eyes, started shaking, apnea. Diagnosed at ER as febrile seizures. Fever continued until 10/8, but not as high as 10/4.
2nd dose  -  on 6pm onwards , fever and headache for the 4 days, Extremely fatigue and nauseas for 2 and 3 days. After day 4 I felt a lot of fatigues for about 10days. 4 days and hives on right side of face and eye. Did not spread. Called doctor and got cream and two months later had hives and tried steroids it clears and comes back. As soon as I stop the medicine the rash come back. My eyes started itching and burning inside of the eye and need eye drops.
Seizures - Patient was hospitalized two days after given vaccines. Was hospitalized for a week. Medical tests/labs results showed an unclear diagnosis but showed patient is now developmentally delayed, has a seizure disorder including infantile spasms, microcephaly and FTT.
Information has been received from a registered nurse concerning a 38 month old male patient who on 21-Jul-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 19-Aug-2003, the patient developed a "severe" case of chickenpox with lesions on his trunk, groin area, in his mouth and ears. The patient had not been seen by a physician and the information was based on the patient's father diagnosis of the condition. Medical attention was not sought and treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Patient was administered TDAP, MCV4 and HPV vaccine -within 15 minutes of the vaccines, she had a syncopal episode and fell forward from her chair on to the ground, then had shaking of limbs that lasted no more than 3 seconds. When picked up she was back to consciousness. She was allowed to remain in observation for another 15-20 minutes, after which she walked out of clinic unassisted. No serious injuries occurred except for a bruise of the forehead.
Lt. deltoid area swollen, red, hard and warm to touch. Treatment and outcome unknown at this time.
Patient was given first dose of Moderna on 9/6 after previously receiving J&J Vaccine on 7/16
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sudden onset severe dizziness, serious nausea (I didn't vomit, but I came close), tiredness.  I managed to fall asleep, and when I awoke about 2 hours later, I felt fine.
Aches for 2/5 days which kept me home and inactive, low fever first day, red rash and itchiness below injection site that lasted 5 or more days, the itchiness continued into the second week but the rash was gone.
24hr progression of pain/warmth/swelling & redness @ inj site w/low grade fever;started on augmentin orally w/gradual resolve over 48hr;suspected vial contamination;
Dizziness, headache, back pain, and difficulty taking a deep breath occurred about 1 minute after injection. Administered BENADRYL and patient started to feel better within a few minutes. Patient resumed normal feelings within 5 minutes.
The patient experienced very bad arm stiffness, fatigue and Bell's Palsy after immunizations.
Not feeling well, fatigue, sleeping a lot, cloudy thinking- finally noted increased urination and thirst in June called PCP obtained urine for possible UTI found glucose +1000 returned for blood glucose 430 and HGA1C 12.5 (for 3 months back) notably HGA1C in Feb 2021 was 5.6 (normal). Asked for antibody test to find out if type 1 DM (as I am not typical of a type 2- active, eating etc) It was positive for Type 1 DM. Taking Metformin and Lantus waiting for an apt with endocrinology to start meal time insulin and plan of care.
11/02/2021 ED physician's note: "Patient states that she has had diffuse abdominal pain associated with nausea and vomiting has been constant in nature over the past x1 week after getting her flu shot.  She also reports dysuria and diarrhea as well as sore throat and chest pain.  She has not been eating well since her sx onset.  No shortness of breath or lightheadedness noted.  Noted to have fever but denies any ill contacts.  States she is fully vaccinated for Covid.  No modification factors of her symptoms". Treatment: decadron, duo-nebs. Pt is still hospitalized.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 09-JAN-2023) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint 90000192454.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Patient received an expired dose of Rotateq/expired 10 days ago; Did not experienced any adverse event; Information has been received from a consumer via a company representative concerning to a 2 month old patient. No medical history, concurrent condtions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. Even lot number and expiration date was not unknown, it was reported that had expired "10 days ago"). No adverse event was experienced.
I was diagnosed by my Dermatologist with Dermatographism shortly after I received Moderns booster shot.
PATIENT CAME IN FOR HER 4 YEAR VACCINES.  RECEIVED DTAP, HEPA, IPV, MMR, & VARIVAX.
pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for an unknown indication.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
administration / of the first adult dose / to a pediatric patient; administration / of the first adult dose / to a pediatric patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 12th May 2021, the patient received the 1st dose of Engerix B adult. On 12th May 2021, unknown after receiving Engerix B adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were reported as follows: The age at vaccination was not reported however it could be 19 years. The pediatric patient received adult dose of Engerix B adult on 12th May 2021 which led to adult product administered to child and overdose. No events were reported. The reporter did not asked for consent to follow up.
elevated temp of 100.6 did not respond to APAP; 3SEP94 PM parents took pt to hosp ER MD prescribed Erythromycin tonsils swelled; blisters in mouth very stiff neck; malaise;
Early in February, prior to the holiday, I developed what seemed like a cold. I had laryngitis and a sore throat and some other cold related symptoms. The Laryngitis hung around for several weeks, and the symptoms seemed to evolve. For 3 to 4 weeks I had a lot of phlegm in my lungs which caused me to hack and cough, which I can still feel to this day. We were traveling during that period and I had a tele-visit on 2/9 and he gave me amoxicillin before we left but I wasn't satisfied with that. I went to an urgent care and they gave me prednisone tablets and an albuterol inhaler. I had a procedure on my toe and he continued my amoxicillin 3 more days. I went on vacation afterwards and visited a lot of people and thankfully no one got sick but I was hacking the whole time. I went to the urgent care  locally and they took a chest x-ray, which was unremarkable. They gave me a prednisone shot and pills and some more amoxicillin. At some point someone recommended ALLEGRA-D, which I did take for a few weeks. The last urgent care wanted to see me back after 5 days to take another chest x-ray. When I went back a different person at the same urgent care, they said it was too soon for another x-ray, and gave me a different steroid shot and recommended taking a probiotic and also prescribed amoxicillin-clav for 7 more days. Got home, symptoms continued. I've been to the doctor twice since then and he stressed that I should use the inhaler more regularly, which I have since done. Monday, 3/20, I had the worst day. I was lethargic, and achy, hacking, headache. I already had a follow up appt tomorrow, 3/24, but I was able to get in at another place sooner and got another chest x-ray Yesterday was a better today and I'm feeling better today but still hacking and wheezing. No results yet. So far it seems like its long COVID, but hopefully I'll learn more tomorrow.
I tested positive for the virus ten days following my Moderna booster shot. I had no symptoms, however I developed a skin rash. It was a mix of itchy hives and welts that would appear randomly on my body and disappear within a few hours only to pop up in other places. It covered almost every inch of my body at separate times. I still have the rash 26 days later.
At 7:30 am- 6/23/04 patient started crying- inconsolable. Had increased temperature. Brought to physician's office. Seen approximately 10:30 am. Still crying. Temperature of 101.6; 102 at home prior. Tylenol administered appropriate dose for weight. Re-examined 2 hours later- crying subsided; child taking bottle.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's roommate called and stated she fainted briefly and asked what she should do. We told her to take benadryl and and to the ER but they didn't. We called back to try and see how she was doing and she never picked up the phone again.
Sore throat. Cough. Phlegm. Fever 101.5. Treated with Paxlovid started 05/26/2022. Symptoms began to subside 05/28/2022
blistering rash started 24 hrs after vaccination on hands- hands then swelled and an erythematous rash appeared on body Rash persisted for 2.5 weeks; hands swelled so much he could not use pencils
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Woke up in the middle of the night and fainted. Fell and hit her head requiring medical attention. Developed severe rash on arm and down torso.
Tested positive for Covid, had no symptoms; Pain at the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (Tested positive for Covid, had no symptoms) and VACCINATION SITE PAIN (Pain at the arm of the injection) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the arm of the injection). On 02-Mar-2021, the patient experienced ASYMPTOMATIC COVID-19 (Tested positive for Covid, had no symptoms). On 12-Feb-2021, VACCINATION SITE PAIN (Pain at the arm of the injection) had resolved. At the time of the report, ASYMPTOMATIC COVID-19 (Tested positive for Covid, had no symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she thought she had Covid some days before she was tested  No concomitant medications were reported.  No treatment information was provided
Approximately 4 days after Hep B immunization right thumb and pointer finger became numb, within a week numbness traveled to slightly above right elbow. Felt lethargic. Family physician referred her to doctor neurologist MRI showed lesions on brain. Neurologist referred patient to doctor MS Clinic doctor.
15MAY2008 - Patient showed signs of malaise, fever, and swollen axillary lymph nodes. Patient prescribed with Naproxen 500mg tabs.    16MAY2008 - Localized Secondary Cellulitis on the left upper arm. Patient prescribed with Keflex 500mg tabs.
recently recovering from COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (recently recovering from COVID-19) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (recently recovering from COVID-19). At the time of the report, COVID-19 (recently recovering from COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Left arm swollen, red down to elbow. Tender at injection site. Used Ibuprofen and cold compresses the first 24 hrs but didn't go away. Pharmacist called her MD and advised pt to got to urgent care.
Information has been received from a 69 year old male physician with hypercholesterolaemia, hypothyroidism, benign prostatic hyperplasia, penicillin and sulfonamide allergy and a history of stent placement 2 years ago who on 15-NOV-2006 was vaccinated IM, into the right arm, with a dose of Pneumovax 23.  Concomitant therapy included LIPITOR, ezetimibe (MSD), SYNTHROID, atenolol (MSD), FLOMAX and AVODART.  On approximately 17-NOV-2006 the patient developed paresthesia and neuropathy in his right arm and right leg.  He reported that the experience is not constant but rather, "it comes and goes."  Unspecified medical attention was sought.  At the time of the report, the paresthesia and neuropathy persisted.  Additional information has been requested.
Subject with recent complicated hospitalization 8/23/2022 - 9/21/022 for bilateral pulmonary embolism requiring heparin drip with right IJ thrombus (not removed) complicated by mesenteric hematoma, atrial fibrillation during this hospitalization. Patient medical history consists of: BPH, bilateral renal cell carcinoma, kidney transplant 2013, Graft failure 2022, Hypertension, bilateral pleural effusions, Hypothyroidism, hematuria, covid19 August 2022. Subject presented to the emergency department on 10/16/2022 due to 3 episodes of syncope at home. He described each episode similarly as him standing up from a seated position, not preceded by any prodrome. He blacked out for a few moments before regaining consciousness. ECG in the ED revealed frequent premature atrial contractions in a pattern of atrial bigeminy. After the episodes he is not had any neurologic or extremity weakness. After the fall he said he laid down a bit but felt dizzy. He still feels dizzy since this morning and had a low blood pressure in the morning. He denies fevers/chest pain/palpitations/abdominal pain. During this hospitalization, his metoprolol was increased from 25 mg daily to twice daily, with improvement to atrial contractions. The syncopal episodes were suspected to be secondary to orthostatic hypotension due to hypovolemia. Nephrology was consulted for management of his dialysis regimen. He was also found to have a TSH of 80. Endocrinology was consulted and the patient was started on IV levothyroxine for 2 days with good response, and subsequently transitioned to oral. 10/18/2022 Subject feeling well and was discharged to home with instructions to continue his medications including metoprolol succinate 25 mg twice daily, furosemide 80 mg daily, apixaban 5 mg twice daily, continue hemodialysis as per usual routine and follow up with endocrinology as an outpatient. Causality per study site P.I. is not related to study medication.
12:30AM body aches  3:30 AM fever, chills, severe body aches, GI problems  12:30 PM starting feeling better  6:30 PM fever, chills, tiredness, severe body aches, GI problems, extreme night sweats  8:00 AM Sunday- starting feeling better
red, hot area, swelling of arm, fever of 103, could not eat, body pains, very tired,    was given shots to conter act swelling, reddness, and hot area of arm requiring 2 separate drs. visits 24 hours apart.  Given prednisone.
13 April 2021/day after receiving 2nd vaccine she had headache, body aches and fatigue for less than 24 hr then resolved. then 3 days later (15 April 2021) she developed headache again, nausea, vomiting, diarrhea.
Body aches, headache, fever of 100 F. This was the second dosage. These symptoms all occurred in the first dosage, too.
I had begun to develop a lump in between the left collarbone and left armpit, swelling up to the size of a large lemon, along with a relative soreness and weakness with the arm in general.  An icepack was used, and went to the emergency room.  It is quite a bit smaller but is still semi visible.  Four months later it has been recommended that we seek physical therapy and we are in the process of finding a physical therapist to have therapy with.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 25-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.