chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having trouble sleeping; Both arms severe aches and pains; Extreme fatigue; A spontaneous report was received from a female consumer of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme fatigue/Fatigue, both arms severe aches and pains/Pain in extremity, having trouble sleeping/ Insomnia,  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) Intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events extreme fatigue, both arms severe aches and pains, having trouble sleeping. Treatment details included None given.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, extreme fatigue, both arms severe aches and pains and having trouble sleeping was unknown at the time of this report.; Reporter'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.
C/O sensation of bugs crawling over skin, started at 9:00pm. Pt was wide awake talking crazy until 4:00am. On wasy to pick up dad, saw a horse sitting on tree, a skunk, a racoon, a guy riding a bike, none were seen by mom.  Pale color
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium
Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.
Right side of lip started swelling about 7:30 pm on 12/31/2020.  Took Benadryl and picked up Epi pen at pharmacy.  Swelling increased overnight up into right cheek and jaw.   Right side eye and cheek and mouth drooping with a crooked smile. On 01/02/2020  started itching from up under right ear down towards neck with redness and hives.   Got RX from pharmacy for Prednisone and am currently taking that
Severe chills, fever, nausea, brain fog, soreness on arm, exhaustion
This case was reported by a lawyer and described the occurrence of skin lesion(s) on multiple body sites in a male subject aged between 50 and 59 years old who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included back pain. Concurrent medications included Anti-inflammatory, Unknown (Epidural), Aspirin and ALEVE. In 1999 the subject received unspecified dose of LYMERIX (unknown). The subject reportedly stated that he believed that he received 3 LYMERIX injections, three months apart, but this was not confirmed. In 1999, immediately after vaccination with LYMERIX, the subject experienced chills, headache, fever, joint pain, joint stiffness, swelling of toe and swelling of fingers. Within a few days after the first dose of LYMERIX, the subject developed skin lesion(s) on multiple body sites, sleep disturbance, hot flashes and facial pain. Between the 1st and 2nd doses of LYMERIX, the subject developed arm pain, knee pain, shoulder pain, finger pain, ankle pain, foot pain, loss of strength, loss of energy, limited mobility and loss of his grip. In spring of 2007, the subject developed intense pain and paralysis in the feet, hands, shoulders and elbows. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
felt a bit feverish; mild body aches; headache; This case was reported by a consumer and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 14th December 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 15th December 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were unknown.   The reporter considered the fever, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the fever, general body pain and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of Shingrix and Flu vaccine on monday, after that on tuesday patient experienced bit feverish with mild body aches and a headache. Patient was informed that these symptoms were good thing,showed that patient's body was beginning to build immunity to these viruses.
Bilateral lower extremity weakness, numbness, tingling, absence of reflexes, MRI and EMG findings consistent with Chronic Inflammatory Demyelinating Polyradiculopathy, treated with IVIG 1g/kg x2, then 10mg of prednisone daily until neurologic followup appointment in 3-4 weeks.
welts/got welts on her neck; painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via unspecified route of administration on an unknown date as first dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient got the first covid vaccine. Last 2 days she got welts on her neck. It was painful. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
suspected vaccination failure; shingles sores; arm hurts ever since; rid of the pain; rid of the pain & blisters; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm, pain and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain in arm, pain and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received a shingles vaccine in 2019. The patient's arm hurts ever since, not to mention the shingles sores were still with the patient. The patient asked what could be done to get rid of the pain and blisters. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Signs and symptoms: Came from nursing home to ED on Nov 4th, with known history of COVID positivity status on October. Respiratory distress. Altered mental status. Diagnosis: COVID test.   2D echo  Chest X-Ray. Treatment:  Intubation.  Vancomycine.  Cefepime.
Patient's son received varicella vaccine on 7/16/10.  Patient was out of town for few days after vaccine was given.  Upon returning home, patient noticed that son had small rash on his chest, that went away after few days.  On 8/1 pt noticed red rash on right arm near her elbow, which spread to her right upper arm, chest, rib cage, and flanks on both sides over next several days.  Patient had had last chemotherapy approximately 2 weeks prior to admission.  WBC on admission was 12.7 and platelet count was 125,000.
Lightheaded, nausea started about 24 hours after shot. at 16 hours, fever started and lasted about 12 hours (went up to 103 even with Tylenol and Advil). Sore arm at injection site. All symptoms except sore arm resolved within 36 hours.
Information has been received from a physician concerning an 12 year old female who on 20-JUN-1999 was vaccinated with the first dose of MMR II (HSA), and the second dose (HSA) on 13-FEB-2002. On 15-NOV-2009 the patient developed mumps. Date of mumps diagnosis reported as 15-NOV-2009. The patient had right parotitis. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
After covid vaccine, unable to move arm for 8 days, slowly subsided. Likely SIRVA. Patient requesting I report this for her.
All shots stopped shingles except the 3rd booster which I developed shingles again every month. Shingles shot never worked was getting shingles every month about same time. After Pfizer 1st shot shingles stopped but started back after 3rd booster every month now.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Approximately on an unknown date in 2012 (reported as over one year ago) the patient was vaccinated with doses 1, GARDASIL (lot #, expiration date and route not reported). Approximately on an unknown date in 2012 (reported as over one year ago) the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported). The patient was new to the office. The patient received dose 3, GARDASIL (lot #, expiration date and route not reported) on 26-MAR-2013 (reported as today) which was late. No symptoms reported. Additional information has been requested.
Mom called office approx. 15 minutes after receiving # 1 dose of PCV 13 mom noticed a rash, like hives on face & neck with no re resp difficulty. CPNP spoke with mom; who reports rash looks like small bump like "goose pimples" initially red in appearance then more skin colored. No urticaria, no SOB. Mom denied follow-up appointment.
symptoms began about a month later, noticeably. fainted at church. felt internal jitters, heavy legs, palpitations. high blood pressure, rapid heart rate out of nowhere, autonomic nervous system disfunction. debilitated- felt like body stuck in fight or flight mode.  high cortisol, symptoms worst early in the morning. brain fog, sensitivity to light. random muscle twitching. collagen damage. -put on blood pressure medication to try & calm body down -took antibiotics for what we thought was Lyme disease(false positive) -Hydroxychloroquine & Ivermectin -numerous supplements & followed a spike protein detox.  -acupuncture & chiropractic care  -hyperbaric oxygen therapy -peptide therapy & nutrient IV's
PATIENT COMPLAINED OF AN ITCHY RASH ALL OVER HER BODY. THE RASH BEGAN SEVERAL HOURS AFTER THE VACCINE WAS ADMINISTERED.
This spontaneous report was received from the mother of a 12-month-old female patient without drug reactions, allergies or pertinent medical history. On 06-OCT-2014 the patient was vaccinated with VARIVAX (Merck) (lot # K003420, expiry date March 2016. Strength, route and dose not provided). There was no concomitant medication. On 14-OCT-2014, 9 days after onset of therapy, patient developed a rash on her abdomen, which eventually spread all over her body. Patient also experienced swelling of her arms and legs, and became cyanotic. These issues resulted in hospitalization on 15-OCT-2014, during which daughter was diagnosed with urticaria. Lab diagnostics performed included full blood count (CBC) and chest X-ray, both with normal results. Treatment included ATARAX and ranitidine, which reporter stated were ineffective at suppressing the rash and were discontinued. Additional treatment included unspecified intravenous (IV) steroids and an unspecified antiviral medication. Patient was discharged from the hospital on 16-OCT-2014. Reporter said everything resolved except the rash, which, at the time of the report, was still persistent. No further information provided. Upon internal review, urticaria was considered as medically significant. Additional information has been requested.
Awoke 1 1/2 days p/vax w/t105.6; no nausea or vomiting; to MD office adm to hosp to r/o spinal meningitis; all test came back neg; on IV fluids & ATB while in hosp;
This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. On an unspecified dates, the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot number and expiration date were not reported). On an unknown date the patient was vaccinated with GARDASIL third dose, 0.5 ml, intramuscular (lot # not provided) and she was pregnant with last menstrual period (LMP) "around" 15-MAR-2014 and estimated date of delivery (EDD) of 20-DEC-2014. It was reported that the patient was also given on 14-MAY-2014 unspecified "meningococcal oligosaccharide with diphtheria conjugate (manufacturer was Novartis). There was no adverse effects reported and no PQC involved. The outcome of pregnancy was pending. Trimester of exposure, gravida, para, date of conception, foetus demographics were not provided. Urine test and Human Chorionic Gonadotropin (HCG) test for pregnancy were performed. The results were not provided. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates, the multiple unspecified patients were vaccinated with GARDASIL, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that he multiple unspecified patients were administered GARDASIL that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
< than 24 hours after injection, redness approximately 3" across at immunization site, no fluctuance as yet.
Symptoms: Nasal congestion, Fullness in ears, Intermittent shortness of breath, Vertigo. Most symptoms persisted for 1.5 weeks. Vertigo present a couple of days. Treatment: Amoxicillin 7-day treatment
Patient called in to pharmacy stating that a few days after his arm pain from the vaccine subsided he started to experience sharp shooting pain in his left arm (the injection had been in his right arm) and a tingling sensation on the left ear that slowly started to get better by the time of his call. The patient was told that this was not likely due to the vaccine and sounded like a medical emergency. He was told to go to the ER immediately.
Information has been received from a female patient of unknown age referring to herself. Patient's medical history, concurrent condition and drug reactions/allergies were not reported. Patient reported that she took the vaccination with ZOSTAVAX back on an unknown date in Septmeber 2014. And according to her, the vaccine caused her to break out all over her body (vaccination failure) on an unknown date. The outcome of vaccination failure was unknown. The patient got called to get a compensation for taking the ZOSTAVAX. She did not wished to reiterate information on what happened. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information is not expected, no contact details were provided.
Fever up to 101.8 few hours after immunization. May have had higher fever the night before seen by MD but Mom did not take temp. PE ok, WBC 14.5, 62% Lymph. Fever gone 11/9/06 and patient with congestion.
Administered Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Patient received second dose of covid vaccine on Thursday.  Friday, patient woke up with hives on face, neck, chest, legs and back with itching.  Throat is scratchy and difficultly speaking.  Patient was taking famotidine and diphenhydramine at home with significant improvement.  Patient is treated with epinephrine, diphenhydramine, dexamethasone and famotidine.  Patient discharged home with steroid taper.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 21-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 21-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
TE for unopen, unused QUADRACEL,DAPTACEL,VAXELIS, MENQUADFI,ADACEL,PENTACEL and IPOL.Excursion started when products were transferred.total time out of range is 39hrs with a min temp of negative 9.1 F.Reported as Medication error due to TE; This non-serious spontaneous safety report, with reference number 2023SA265316 (Inquiry number), was received by the partner on 30-AUG-2023 and forwarded to agency on 31-AUG-2023, from a health professional.  This case was considered non-valid due to no patient identifiers provided (temperature excursion only).  Due to the nature of the event, the causality between the event " TE for unopen, unused QUADRACEL, DAPTACEL, VAXELIS, MENQUADFI, ADACEL, PENTACEL and IPOL. Excursion started when products were transferred. Total time out of range is 39hrs with a min temp of negative 9.1 Reported as Medication error due to TE" and Vaxelis was not applicable.  No further information is expected.
anterior uveitis - dual eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6208) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EN5318,, prev dose lot unknown: False, prev dose administration date: 19Feb2021, prev dose number: 1, prev dose vaccine location: Right arm), administration date: 19Feb2021, when the patient was 36 years old, for COVID-19 immunization.The following information was reported: IRIDOCYCLITIS (non-serious) with onset 17May2021, outcome "not recovered", described as "anterior uveitis - dual eye". The event "anterior uveitis - dual eye" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of iridocyclitis.  Clinical Course: Facility type vaccine was other. There was No other vaccine in four weeks and no other medications in two weeks. Treatment received for AE was steroid eye drops. There was no COVID prior vaccination. COVID tested post vaccination with Nasal Swab and test result was found as negative.  No follow-up attempts are possible; no information is necessary.
Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days; then Diarrhea & bloating for 24 hrs; then prior symptoms gone but very weak & tired  - for 4 days  (the first day had low blood pressure); then general malaise for 1 week
Two doses of the Moderna vaccine within 3 days; A spontaneous report  was received from a Healthcare professional (HCP) concerning one of her patients, of unspecified age and gender, who received Moderna (mRNA-1273) and who experienced two doses of the Moderna vaccine within 3 days.  The patient's medical history was not provided. Concomitant product use was not provided.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date for prophylaxis of COVID-19 infection.  HCP reported that one of her patient got two doses of the Moderna vaccine within 3 days (Inappropriate schedule of product administration), and would like to know how far they are supposed to be spaced out. When should the true second dose should be given.  Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event two doses of the Moderna vaccine within 3 days was resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, unknown lot number with no associated AEs. Causality for this medication error is not applicable.
AFTER RECEIVING THE VACCINE SHE FELT WOOZY. ONS ITE EMS RESPONEDED. HER VITALS ARE BELOW. SHE REFUSE FURTHER EVALUATION AND CARE AND WENT HOME
10:45 pt reported not feeling well; He complained of feeling nauseas and weak. Assisted pt to lie down on cot;  Nursing assessment done, vital signs taken, pt offered water, history taken from pt and wife; mental status assesed; 911 called;RN    stayed with pt until EMS took pt to hospital via ambulance for further evaluation.
pt recv vax; c/o HA, fatigue, n & inc warmth; tx w/ dph; instructed to go to er;
I had 2 episodes where I got really weak, and I went in to be seen in the ER. I advised them that I was weak and they did a CAT scan. I got a fever of 100.4 and I was admitted on November 18, 2022. They did a COVID-19 PCR, and it came back positive Sunday Morning I was given 3 days of remdesivir. I started Occupational and Physical therapy on November 19, 2022. I residual weakness. I remained in the hospital for 1 week and acute rehab for 1 week. I am still in physical rehab. I covered from the COVID-19 but not from the stroke.
2/27/03: TD, Hep B, MMR vaccines for INS 3/27/03: Hep B, Varivax 4/10/03: Tetanus booster for needle stick 4/8 4/12/03: Rash - seen 4/14 - Dx chicken pox. Not ill, no fever, more than 20 lesions.
On 11/19/2015 patient was seen in ER for bursitis from reaction to flu vaccine on 10/29/2015. Patient advises recommendation for therapy twice weekly.
Patient reports pain in her shoulder after receiving vaccine. She is unable to move her arm, and feels pain, especially when lying down, lifts her arm, rotates her shoulder, and when lifting objects. Her range of motion is limited.