chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rash on both forearms; Rash with extrem itiching; decided not to take secound dose; redness; hives; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hand dermatitis (Allergy to preservatives.).    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives). On 22-Jul-2021, RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on 22-Jul-2021.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received 0n 11 AUG 2021 contains significant information about patient i.e;   reporter mail ID added, patient race and ethnicity, allergies and events added. On 03-Sep-2021: Follow up received contains no new information.
Patient was due for 2nd dose of Bexsero, but was given a 3rd dose of Menactra instead.  Once this was realized, patient was administered the 2nd dose of Bexsero.
A fever of 101, chills, exhausting, headache, body aches, fatigue, and finger swelling.  I still have swelling of my hands and get brain fog
lot of arm soreness for the first 3 days; first day it was hard to lift the arm up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) and MOBILITY DECREASED (first day it was hard to lift the arm up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CORTISONE for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) and MOBILITY DECREASED (first day it was hard to lift the arm up). On 02-Jun-2021, MOBILITY DECREASED (first day it was hard to lift the arm up) had resolved. On 05-Jun-2021, PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Mild dizziness. Tachycardic, mildly hypertensive. Appears anxious. Given water. Heart rate & dizziness resolved, stable, released from vaccination site.
General sleepiness, fever lasting about 12 hours recorded highest at 101.6 measured under the tongue. General feeling of being hit by a truck and headache.
Previously healthy 34 year old black female has had progressively worsening neuro, GI and muscular skeletal symptoms since receiving 7 Anthrax vaccines. After 1st shot, had migraines with 15 to 22 medical visits from 3/19/98 to 6/11/01. She has chronic fatigue; was a runner prior to 2/98 but now barely able to run/walk 1/4 mile. Fibromyalgia, generalized with migratory muscle spasm and pain poorly controlled. Elavil recommended on 7/12/01. Paresthesias with migratory hypesthesia. Anemia with Sickle Trait. GERD with trial of Prilosec with partial relief. She has recurrent symptoms of Vaginitis; self treated with OTC at least 10-12 times/year; candida or bacterial vaginosis documented in chart, never prior to 1998. Situational stress; fear of loss of health, job, quality of life. Anthrax vaccine temporarily exempted X 1 year starting 8/01. She also has GI pains.
Development of Blisters on tips of fingers. Started within 12 hours of receiving the vaccine.    Still present today 6/7/21 .  Not limiting his activities
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu-like symptoms (fever, muscle aches) beginning ~6 hours after vaccination.... and black/blue bruise around injection site (developing 24 hours later and still somewhat apparent (faint dark-coloring on skin) about 2 weeks later.
102.8*F fever, Severe fatigue, chills, myalgia, sore arm
04/20/07 approx 8 AM. Mother noticed red, warm, tender, swelling on right upper arm of child 04/20/07 approx 1 cm size of above lesion 8 1/2 x 9 1/2 cm treatment. Cool compress. Motrin/Benadryl
Sick and achy for three days. Both hands randomly going numb, and everything taste sour.
Very rapid, pounding heartbeat for about 20 minutes, then felt queasy, shakey.  By the time I saw a doctor, about an hour later, all was normal (pulse, blood pressure, ECG).
HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart palpitations was not reported. This report was non-serious. This case, from the same reporter is linked to 20220113961 and 20220114079.
lethargic; tired; little headache; face got red; felt flush; skin was itching; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and LETHARGY (lethargic) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (little headache). On an unknown date, the patient experienced LETHARGY (lethargic) and FATIGUE (tired). At the time of the report, ERYTHEMA (face got red), FLUSHING (felt flush), PRURITUS (skin was itching), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), HEADACHE (little headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 161/100 (High) 161/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 included no new information.
Woke up during the night gasping for air. Throat felt like it was closing in heart, racing.  Duration several hours.
I have developed tinnitus after receiving the vaccine. My husband received the same vaccine at exactly the same time and has also developed tinnitus.
Began with a sore throat, progressed throughout the day to headache, severe body aches, chills, and a fever of 103.8. Took to clinic- strep and flu test were negative (strep culture sent out) called primary and was advised to continue ibuprofen 3x day and add Zyrtec for 1 week- was said to be having a reaction to vaccination.
expired dose of Tenivac inadvertently administered, no advesre event; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown demographic patient who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number U5854AB and expiration date 30-Jun-2020) as prophylactic vaccination on an unknown date via unknown route at an unknown administration site.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient began experiencing left sided chest pain around 1300 on 4/25. He had 2-3 brief episodes of fainting, each lasting 2-5 seconds. RH 41 and SpO2 98-99%. His parents took him to the Emergency Department at hospital and he was admitted to the ED at 1320. 4/25 in ED, he had blood drawn for labs, EKG twice, and CKR, had elevated Troponin and was started on IV Heparin, then was transferred via ambulance for direct admission for cardiology evaluation at hospital. 4/25 in hospital: repeat EKG was WNL, CT of lungs showed no PE/clots; repeated Troponin (3.2ng/ml) and other labs. His chest pain stopped around 1900-1930.  4/26 in hospital: Troponin peak 4.9 4/26 in hospital: Troponin peaked at 4.9ng/ml with AM labs, then dropped to 4.2 later in the day; had echocardiogram and heart CT with contrast, no wall abnormalities, no valve abnormalities, no clots, no arrhythmia (does have occasional PVCs); Heparin was stopped later in day. 4/27 in hospital: Infectious Disease doctor was consulted due to elevated inflammatory marker level in bloodwork. Doctor drew viral labs to evaluate for viral myocarditis. Patient was discharged from the hospital at lunchtime.  5/6/21: follow up with Doctor, virtual visit, released Patient from cardiology care/follow-up 5/12/21: follow up with Doctor, he informed Patient his viral lab tests were positive for Coxsackie virus B3and B4, and diagnosed him with viral myocarditis and no further follow-up 6/10/21: follow up with PCP, recommended further cardiology and repeat bloodwork in the next 2 months, due to correlation of myocarditis with COVID vaccine.   Patient had no illness symptoms the month prior to receiving dose #2 of Moderna vaccine. He had chills, sweats, and mild body aches beginning 4/25/21 and lasting until the night of 4/26/21  Doctor, infectious disease specialist  Doctor, cardiology Doctor, Internal Medicine/PCP
Patient passed out after receiving janssen covid-19 vaccine. There was no injection site reaction, no wheezing, or rash/hives. Patient had vision loss, dilated pupils, sweaty, unable focus or respond to use questions being asked, and  was having trouble hearing-said he had ringing in his ears. We were able to lay him on the floor without injuries-he did not fall. I was fanning him and we were talking to him. He got a little worse but then got better. When he was better, he said that he had passed out before when having blood taken. He did not mention this to me before the vaccine was administered. I do not feel that the Janssen COVID shot was the cause, I think he just passes out from injections or needles. We did call 911 when he was getting worse. By the time they got here, he was better but they did check him.
Developed a fever of 101, pain and swelling in my shoulder, sluggish feeling.  Fever was gone the next day.  The only residual was pain in the shoulder.
After 6 minutes I developed chest tightness/heaviness.  I had an odd sensation from mid chest to back of throat.  The back of my tongue became tingly and numb. The back of my tongue swelled a little about 3 minutes  after initial symptoms.  I developed itchiness at about 12 min. The chest heaviness progressively  worsened. I was taken to the ER. My vitals were taken. My BP was 126/80s, afebrile.  I was told to sit in the waiting room. After being in the ER and not evaluated by a medical doctor I self treated. I carry allergy meds. I took a swig of liquid Benadryl and 2 puffs  on my Albuterol inhaler. I waited a bit longer,  Noone called me back so I left..  About 1.5 hrs later I took Loratidine 10mg. That evening  I took Singulair  10mg and used my symbicort inhaler. I'm a RN
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had not known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Instantly felt chest tightness and difficulty breathing, Lasted around an hour.  Also couldn't use arm for over a week, and felt like crap for days.  Did not report to nurse, just got up and went home.  Had no choice. Had a handicapped son with me and he had wandered outside.  He cannot be left alone.  Got home the feeling lingered.
Hospitalized 9/20/21 from skilled nursing facility, SARS-CoV-2 positive 9/20/21,  acute hypoxic respiratory failure due to Covid 19 Pneumonia
Day after the 2nd dose, I had the following symptoms which lasted about 1 day: Chills Fatigue Body aches Nausea Brain fog
Initial report was received from a consumer, who was also the patient's parent, on 30-December-2011. A 16-year-old male patient had received an intramuscular injection in the right deltoid of MENACTRA, sanofi pasteur Inc., lot number U4040AA, in the morning on 01 December 2011. On the evening of the vaccination, the patient became sluggish. The next day, by the afternoon, the patient could not get up off the couch, all extremities were weakened, the patient had a migraine, difficulty swallowing and redness, swelling and pain from the shoulder to the elbow on the left arm. The symptoms were gone by Sunday, except for redness and swelling of arm. The patient was seen by a pediatrician and was diagnosed with reaction to vaccine. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
diffuse red macular rash-small spots on torso, face & extremities; low grade fever
developed rash 6 days after vaccination. Saw urgent care doctor who thought related to recent vaccine. Came to my office for follwup and rash looked most consistent with erythema multiforme.  Labs ordered to see if a possible recent illness could explain the rash or cause the erythema multiforme. Rash is still present.
compromised breathing after the first dose; a heart thing; lethargy after the first dose; general achiness after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient's friend). A 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (age at vaccination: 79 or 80 years) (Lot number and expiry date was not reported) as dose 1, single for COVID-19 immunization. The patient past Medical history included COVID-19 from Dec2020 to Dec2020 and asthma. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. The patient has not received other medications in two weeks. On an unspecified date, after the first dose of the vaccine, his friend had compromised breathing and his wife took him to the emergency room for his breathing or a heart thing. He was in and out and my have not been related. He was checked out and released. He also experienced lethargy and generalized achiness the day after getting the vaccine on an unspecified date. The compromised breathing lasted for about a week. He started experiencing lethargy the day after getting the vaccine. This lasted for about 8 days. The day after getting the vaccine he felt general achiness. This also lasted about 8 day. The patient underwent lab tests and procedures which includes, tested positive for COVID in Dec2020. The event outcome was recovered for compromised breathing, heart thing after a week and lethargy and general achiness recovered after 8days on unspecified date.   Information on the batch/lot number has been requested.
Pt recvd vax & exp pain both arms, from deltoid area through fingers; MD put pt on Pred 6 days w/relief; was off Pred for 2 wks & had repeat severe bilateraly upper extremity pain; seen by neurologist;
tested high risk positive for a (unknown) strand of HPV a couple of weeks ago/ tested possitive for HPV; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; therapy start date: August 2013/ therapy end date: August 2014.; when my daughter received the first two doses of GARDASIL she almost passed out, had to lie down, she was seeing light and she looked gray; This spontaneous report was received from the patient's mother, referring to a currently 23-year-old female patient. The patient had none concomitant medications, pertinent medical history, concurrent conditions, or drug reactions or allergies.  On an unknown day in August 2013 and August 2014, the patient was vaccinated with the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) as prophylaxis, route of administration was reported as "shot" (anatomical location was not reported; lot number and expiration date were unknown by the reporter) (inappropriate schedule of product administration).  When the patient received the first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she almost passed out, had to lie down,  she was seeing light and she looked gray (dizziness). The patient chose not to get the third dose because she almost passed out.  On an unspecified date (also reported as "a couple of weeks ago"), the patient was performed a colposcopy. The patient tested high risk positive for an unknown strand of human papillomavirus (HPV) (also reported as "tested positive for HPV") (human papilloma virus test positive).  The patient sougth medical attention in the doctor's office. It was reported that the patient did not received treatment for the events.  The outcome of the human papilloma virus test positive was reported as not recovered. The outcome of both episodes of dizziness was not reported.   The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the aforementioned events was not provided.
Pt became pale approx 1/2 min after injection. Asked if he was OK and he did not answer. Assisted to exam table to lie down. Gave cool compress. Pt BP 130/80 P 88. Offered water and orange. After 10 min had pt slowly sit up and he was fine. VSS.
Minor soreness the day of the vaccine but have had continued are pain at the injection site and surrounding muscles for almost three weeks.  Saw my primary and she said it could be they gave it too high and irritated the shoulder joint.  She is concerned about "frozen shoulder".  It wakes me in the night and no position lasts without pain after 30-45 seconds.  Take one extra strength Tylenol before bed and administer Sagely 250 mg. BD cream on upper arm and part of neck where pain exits.  Last night I drank 3 glasses of red wine so I could sleep a few hours and today I have had no pain!   little weakness and I'm trying not to aggravate it, but hopefully the site pain is resolving.
Complained of severe headache, dizziness, chills.  Had sore body, body aches and fever 101.8.
no adverse reaction to vax was reported to clinic; pt death was seen in newspaper; copy of autopsy & death certificate to follow;
First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/2021: no immediate adverse reaction other than soreness at injection site & general feeling of unwellness. Days after, tingling in the fingersuntil the 17th, rib and back pain began. Pain radiated and worsened over the next two days. Was seen by PCM 04/20/2021, sent for XRAY, CAT scan, and ER, immediate diagnosis of Pulmonary Embolism in the right lung, as well as lung infarct in lower portion.
Large erythema to the left arm/hard knot from inj site. Diphenhydramine 50 mg BID.
he felt like he had the flu for 3-4 days; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate (Fluticasone Diskus) inhalation powder for asthma and reactive airways disease and salmeterol xinafoate (Salmeterol Diskus) for asthma and reactive airways disease.   The patient's past medical history included knee pain. Previously administered products included Advair Diskus (received 1 puff twice dailyand started in 2000). Concurrent medical conditions included asthma and reactive airways disease. Concomitant products included ipratropium bromide, salbutamol sulfate (Combivent) and glucosamine.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Fluticasone Diskus at an unknown dose and frequency and Salmeterol Diskus at an unknown dose and frequency. On an unknown date, less than 4 months after receiving Shingrix, less than a year after starting Fluticasone Diskus and an unknown time after starting Combivent and glucosamine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix and Fluticasone Diskus.  Additional details were received as follows: The patient received the 1st dose in September 2019 and had the flu for 3 to 4 days. For tolerance to 2nd dose, refer case US2020AMR022223.
Patient called complaining of lymph node swelling on the left side (same side as both injections) moving into his jaw.  I recommended emergency room visit.
Fatigue Joint pain  Headache  Swelling at injection site  Itchy at injection site