chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 8th day after receiving my Moderna COVID-19 Vaccine EUA shot, I woke to a red, 2-inch, raised, , itchy rash at the site of my shot.  I looked up the symptoms, which were all related to a condition being called COVID-vaccine arm.   The article said to contact my health provider (Dr.); I did. It futher suggested I report it to the vaccine provider.  I was told to report it on this form.  I am.    The article - and my physician - said to monitor the site and to call if I had other symptoms/the symptoms worsen/the symptoms didn't go away.    The itch went away on the 12th day.  The redness went away on the 13th day.    I still plan to get my 2nd shot.
Breakthrough case after 3 vaccines  Pfizer 1/12/21 Lot# El9261;  Pfizer 2/11/21 Lot# EM9810;  Pfizer 11/18/21 Lot# FF2590
Baby born with left kidney hydronephrosis with blocked drainage or  kinked ureter requiring surgical repair. Problem was detected in utero.
I had severe congestion and diarrhea. My wife was also ill. This  prompted me to take the at home test and tested positive. I was advised to rest and drink a lot of water. I was checking my O2 levels also but was more concerned about my wife. We were sent to get an infusion on that Thursday after testing positive. The doctor did a video appointment with me prior to the appointment and set it up. I have completely recovered.
After 10 min waiting she felt tightness in the throat, as if something was stuck in her throat, she went to the bathroom to throw up, the nurse went to check her and she realized it was the allergic reaction, she was taking to the nurse's room, by then which she was showing symptoms of difficulty breathing, that was when the epi pen was administered.    A nurse stayed with her for observation. EMT came into the building bringing more equipment. Once her condition improved, the nurses suggested her that the next step should be going to a hospital to follow up and to be under care and observation. She declined, then the EMT offered her to take her in the ambulance to the hospital, which is the protocol, but she declin
I had a mild/moderate reaction to the vaccine with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) 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, the patient experienced VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses). At the time of the report, VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) outcome was unknown.      Concomitants were not provided. Treatment was not given.   This case was linked to MOD-2021-294219 (Patient Link).
Pain beginning on day 6 in right index. Inability to bend finger completely. Pain lasts all day with few moments of relief. Blood tests and x-ray show no visual problems. Pain is not getting any better or worse and has been the same since day 6. It impairs me daily from my activities.
Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech dose number: 4; Moderna dose number: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown), 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. Patient had no known allergies. Patient was not pregnant. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2022 at 17:00, outcome "unknown", described as "Pfizer/BioNTech dose number: 4; Moderna dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 11Dec2022 to 16Dec2022 as COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events interchange of vaccine products, drug ineffective, COVID-19 and the suspect drug cannot be excluded.
patient called letting us know that she woke up  the following morning with flu like symptoms, and red rash/hives around the neck.
Vaccine failure. Has 6-8 pox on trunk and 1 on forehead.
Vomiting, itching, hives; acute onset 5 minutes after vaccine administration. BENADRYL given PO and EPI 0.15 mg IM. Transported via EMS to Emergency Room.
An adverse symptom has not been reported.  But a vaccine was given outside the 12 hour window of expiration (less than 24 hours).  The company is contacting the manufacturer and clinical team to determine the correct course of action.
fever 100 degrees, full body aches,nausea, lasting 48 hours,the sickest I have ever been, including shingles vaccine.
A large red area developed at the injection site 10 days post injection, with severe itching and burning for a few hours. A small welt developed at the injection site. Reaction was gone by the following day.
Mild flu like symptoms started 1/5: low grade fever of 99.3-100.5, sore arm at injection site, body aches, fatigued. 1/6: Fever and body aches gone. Hot flashes/sweating for half the day and tired.  1/7: all better, no more symptoms.
Pt complained of fever 102.5 approximately 8 hours after immunizations, with swelling and redness.
fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.7) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D24C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure abnormal. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and ATORVASTATIN for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 101.7). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Body temperature: 101.7 (High) 101.7 degree.     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 medications include blood pressure medication.
PATIENT LOSS CONSCIOUSNESS FOR LESS THAN 10 SECONDS WITH SIGNS AND SYMPTOMS OF SEIZURE (MUSCLE RIGIDITY/SPASMS, EYES ROLLED BACKED). PRIOR TO LOSING CONSCIOUSNESS, PATIENT WAS PALE AND SWEATY AND CLAIMED TO FEEL LIGHTHEADED. PATIENT REGAINED CONSCIOUSNESS AND GIVEN WATER AND CRACKERS. ASKED TO LIE DOWN FOR ABOUT 5-10 MIN.  EXPRESSED A TINGLING SENSATION AFTER REGAINED CONSCIOUSNESS AND A CONTUSION FROM WHERE HE FELL.  GIVEN IBUPROFEN 200 MG TO HELP WITH THE HEADACHE. ALSO APPLIED COLD WET TOWEL TO PATIENT HEAD. COUNSELED PATIENT TO REMAIN IN PHARMACY FOR ABOUT 20-25 MIN UNTIL HE WAS WELL ENOUGH TO LEAVE.  PATIENT EXPRESSED THAT HE FELT FINE TO LEAVE AFTER RESTING, REPORTED NO MORE TINGLING SENSATION, AND ABLE TO SPEAK CLEARLY AND WAS ABLE WALK AROUND. PATIENT DOES NOT HAVE PRIMARY CARE PROVIDER FOR REPORTING. PATIENT REFUSED EMERGENCY RESPONSE/AMBULANCE. WILL FOLLOW UP IN ABOUT 2 HOURS.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 17-SEP-2015, the patient was vaccinated with GARDASIL 9, intramuscularly in the dorsogluteal muscle (dose, frequency, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Left thigh cellulitis. Vaccines given day prior. Redness, induration, tenderness. Given Augmentin x1
Erythematous. Macular and papular rash at abdomen, neck and back started on 7/5/14. (about 9-10 days after vaccination). Associate symptoms includes fever (last night at maximun 99 degrees F). Negative for lymphadenopathy, painful rash, vomiting and wheezing.
Patient lost consciousness for approx. 10-15 seconds 1-2 minutes after receiving the immunization. She regained consciousness and I monitored her vital signs until EMTS arrived. She was given IV fluids, had a low BP of approx 80/50 and was taken to a local ER.
On 7/17/07 patient diagnosed with shingles and pain. Information has been received from a nurse concerning a 74 year old female with history of Hodgkin's disease and chemotherapy, six years ago, who on 04-JAN-2007 was vaccinated SC on the left arm with a first dose of ZOSTAVAX (Merck) (lot# 652947/1411F). Concomitant therapy included lovastatin (manufacturer unknown). FLOSNASE. ALLERGA. GLUCOPHAGE. On 17-JUL-2007 the patient developed shingles on the first flank area. At the time of the report the shingles was spreading. Medical attention was sought and treatment included DEMEROL for pain, DARVOCET and VALTREX. At the time of the report the patient had not recovered. No additional information was provided. There was no product quality complaint involved. Additional information from another nurse indicated that the patient was enrolled in the program: the program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. The specimen was collected by the physician and was being sent for evaluation. Follow up information was received it was reported that the PCR sample was damaged during delivery and the HCP would not be resending another sample. Additional information has been requested.
I received the Moderna vac and got really sick both times; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I received the Moderna vac and got really sick both times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I received the Moderna vac and got really sick both times). At the time of the report, ILLNESS (I received the Moderna vac and got really sick both times) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment information was provided.   This case was linked to MOD-2021-413612 (Patient Link).
Pt presents to ER from prompt care after having reaction to covid vaccine. Pt states he received first dose of Pfizer vaccine at 0930 and starting itching at approx 1010. Pt states he also feels like there is a pill stuck in his throat. Pt was given epinephrine at prompt care and then sent to emergency deparment for further evaluation and treatment. No swelling of tongue or lips noted.
Mom noted immediate fussiness, then suspected loss of hearing- patient would make noises (repetitive), almost as if trying to see if she can hear herself. Specialists noted that she would not turn to noise in either ear with banging on pots. Another office noted similar findings with clapping. Mom notes that she started responding again to noises in the right ear the week of 5/15 and in the left ear 5/25/12.
Gave Pfizer for second dose when patient received Moderna for first dose. No reaction during patients observation.
This is a spontaneous case, initially received on 24-Sep-2018, reported by other health professional (nurse), concerning a 79-year-old, elderly, female patient. The patient's historical conditions included: hypertension, cerebrovascular accident, arterial aneurysm, post-menopausal osteoporosis, mitral valve prolapse, lumbar spinal stenosis, major depression, osteoarthritis of the knee and prolapse of uterus mucosa. The patient's current condition was hyperlipidaemia (reported as medical history). The concomitant medication included: LIPITOR for an unknown indication. Since an unspecified date (reported as Saturday, 1 o'clock until this morning at 7 o'clock), the suspect vaccine FLUAD TIV underwent temperature excursion for 42 hours (explicitly coded as incorrect product storage). The average room temperature was reported to be 72-degree Fahrenheit. On 24-Sep-2018, the patient was administered FLUAD TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 250791 and expiry date: 30-Apr-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after the vaccination. The reporter assessed the case as non-serious.
Pt c/o (L) arm pain x 7 days after injection then burning to left arm with increasing severity. Loss of strength on Sat. Diagnosed with possible Brachial Plexis irritation (L) arm pain.  1/8/08 Reviewed clinic medical records which reveal patient seen 12/21/07 with left shoulder pain x 7 days.  Exam revealed limited flexion/extension of left shoulder w/pain.  DX: myalgia, myositis.  Returned to clinic on 12/27 s/p ER visit for left shoulder/arm pain, sore throat & runny nose.  Dx in ER w/brachioplexy.  Referred to neurology.  Exam on 12/27 revealed positive impingement sign w/decreased left arm strength. FINAL DX: brachial neuritis.
- Rash after Zoster vaccine administer (Mild Herpes Zoster, left abdomen)
For second vaccine high fever of 105.3 noted at 2300 day of vaccination. Tylenol was taken at 2030 day of vaccination due to body aches and no fever noted at that time.  Went back to bed woke at 0130 with fever of 105.3, body aches and chills.  Took cool shower applied cool compresses and went back to bed fever went down to 101.  Woke at 0300 and fever back  to 104. Went to er. Er gave Advil and sent me hone. Alternated Tylenol and advil. Fever still present without fever reducers.
Severe and chronic asthma and allergies emerged, INCLUDING bronchiolitis, wheezing, asthma
Allergic Reaction to the COVID-19 mRNA vaccine. Reporter to primary care in clinic. High severity reaction - angioedema.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
5-10 minutes after vaccination, child suffered seizure-like symptoms including loss of consciousness, stiffening of arms and leg joints, eyes rolling back.  These symptoms lasted 1-2 minutes.  Child regained consciousness and was able to sit up and speak.  Paramedics were called and child was evaluated.  The mother opted not to take the child to emergency room.  Mother was contacted on December 9 in the morning, and stated the child was well and she sent her child to school.
Herpes zoster diagnosis in a one-dose varicella vaccine recipient. Child was in remission from leukemia. Also has history of eczema. Hospitalized from 5/14-5/23/15. Painful rash in multiple dermatomes.
This spontaneous report as received from a physician via company representative refers to a 64 year old female patient. The patient did not have any medical history and drug reactions or allergies were unknown. On 09-SEP-2015, the patient was vaccinated with a one time injection of ZOSTAVAX (subcutaneously, lot# and expiration date were not reported). No concomitant therapy was reported.  In approximately March 2016, 6 months after vaccination, the patient experienced viral encephalitis which caused her to be in and out of hospital. It was reported that the patient had mental status changes and was positively tested for herpes. Unspecified treatment was given for the event. Patient sought medical attention, she visited a provider on 04-APR-2016. The outcome of the events was not recovered/not resolved, the patient was not doing well. Causality assessment was not reported. The reporter considered the event of viral encephalitis to be disabling. Upon internal review, the event of viral encephalitis was considered to be medically significant. Additional information has been requested.
This non-valid spontaneous report was received from a medical assistant, and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, (lot # N021101 with an expiration date 28-FEB-2019), for prophylaxis, (dose, frequency and strength were not provided), that underwent a temperature excursion of 34 degrees Fahrenheit during a time frame of 2 hours and 30 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect were reported and no product quality complaint (PQC) was involved. Follow up information has been received from the physician on 15-MAR-2018 referring to a 2 months old male patient. On 12-FEB-2018, the patient was vaccinated with the second dose of improperly stored ROTATEQ (lot# N021099 with expiration date 02-FEB-2019 (previously reported as lot # N021101 with an expiration date 28-FEB-2019)). The patient had no illness at time of vaccination. No reaction noted.
Narrative:  72yo male pt died on 10/2/21 in home hospice care. Death caused by Progressive metastatic prostate cancer. Pt had received covid vaccines on 02/17/21 & 1/19/21. Death is not related to vaccines.
In mid-April I began to notice very mild neurological symptoms in my right arm and leg - pins and needles, shooting pain down the extremity, numbness, very slight weakness. I have a history of radiculopathy and lumbar spinal arthritis but no recent history of injury or falls, so I attempted home treatment for a while but when that was ineffective after 2 weeks and symptoms were gradually and slowly worsening, I scheduled an appointment with my physician. I saw my physician on 05/21/2021 and he ordered x-rays (taken 5/26/2021), lab work, and an EMG/neurology consult (scheduled September). After the x-ray, the numbness, tingling, and pain in my R arm and R leg worsened and is now causing significant sleep disruption. Also now accompanied by similar symptoms in my R flank/side and pain in my spine from neck to tailbone. On 05/27/2021, I noticed that the right side of my face appears to be affected as well, with muscle spasm/jerking in my right cheek when I smile broadly. No facial drooping, difficulty speaking or swallowing, or respiratory involvement is noted at this time.
swelling around the injection site; Hot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.