chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning following vaccination, I had shortness of breath, chest pressure, nausea and fatigue. I called Walgreens pharmacy where I received my vaccination thinking this was not a normal reaction. They told me to head to the urgent care. Once at the urgent care, they ran an ekg, which showed a possible incomplete right bundle branch block. They rushed me in an ambulance over to the nearest ER. Ran a full  blood and metabolic panel, another ekg, and chest x-ray. All came back normal. Over the next few hours symptoms dissipated. Doc mentions the possibility of myocarditis. Tells me to come back to the ER if symptoms return. Symptoms come and go over the week but then come back strong. Check in to the same ER, they run the same tests in addition to an ultrasound on my heart. Tests return back normal. Doc recommends checking in with my primary care doc in a week and mentions that my body is most likely creating some kind of inflammatory response to the vaccine and that if this continues we may have to run more tests. A week later I see my primary care doc, still experiencing shortness of breath but not as severe throughout the week. Doc prescribes an albuterol inhaler and mentions if things don't clear up we may want to try prednisone. The doctor thinks I may have a mild case of myocarditis. Symptoms flared up again, I then startee prednisone. The shortness of breath seems combated, chest pressure/pain continues on and off. Doctor referred me out to a pulmonary specialist.
L shoulder sore and stiff X 3 weeks, no response to ice and ibuprofen; no erythema or swelling now seeking PMD visit and physical therapy offered. Unknown if neuritis at this time.
pt recv vax; 48 hr later,exp severe HA,aching in joints & muscles,fever,sore throat on rt side & gen swelling;was hosp on 10jun95 & 11jun95;to er;MD indicated allergic rxn; as of 17jun95 pt had only mild aches & "was ready to do more";
Patient had some Nausea after vaccine as well as pain in the arm, heaviness and she developed redness below the injection site that is still warm to touch today 3/19/19. Per patient the symptoms started the night the shot was given. The redness, pain and warmness to the area are still present at the time of the visit this morning.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 19-FEB-2014 the patient was vaccinated with a dose of M-M-R (lot # unspecified, expiration date 01-FEB-2014), (dose and route unspecified). No adverse effects reported. Additional information has been requested.
pt recvd vax 22DEC92 & following vax pt devel pain in the inject site, swelling, dizziness, h/a, flushing in upper chest & neck, nausea, arthralgia & pain in the arm & neck areas; also felt warm & then chilled;
After about 5 hours he started feeling like his throat was swelling shut, and his face started to swell.
Following COVID-19 booster shot I experienced extreme urticaria on eyelids, face, neck, arms, legs, and back, and itching palms requiring me to seek medical attention via doctor as eyes were swelling shut and was prescribed 40MG of Prednisone every day for 5 days. Hives have continued to recur when antihistamines are not taken daily. I have not changed diet, soaps, detergent, shampoos, conditioners or any other aspects of lifestyle.  I have since sought out treatment from doctor who has referred me to an allergist.
Pt said he felt really sick and ended up in emergency room. He is better now, but just wanted to bring it under our attention.
developed bruising on inner thighs 2-3 days after second COVID-19 vaccine - received Pfizer as first dose and incorrectly Moderna as second dose 3 weeks later
On January 28th, 2022, I started to feel a tingly sensation on the right side of my face and now it feels numb. I waited to call and went to the doctor on Feb 11th, and saw Doctor. She did an evaluation and examined me and scheduled an MRI for today.
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
After my vaccine, I experienced COVID-19 on 03/27/2023. My symptoms scratchy throat, hoarseness progressed into a terrible headache, runny nose and progressed into a yucky cough. My doctor called a prescription for PAXLOVID yesterday evening and I took my second dose this morning. The runny nose has slowed down, the cough is still croppy, but has decreased in frequency and my headaches comes and goes. We had gone on a cruise and had a slight fever in the evenings at night time, but no fever today. I did two self tests for COVID-19 tests at home on 03/29/2023. I also took the Omicron vaccine on 09/9/2022.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 29 years 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's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information.
SORENESS IN ARM WHERE INJECTION WAS RECEIVED/TENDER TOUCH AT INJECTION SITE; REDNESS AT INJECTION SITE 2 INCHES  WIDE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced soreness in arm where injection was received/tender touch at injection site. On 13-NOV-2021, the patient experienced redness at injection site 2 inches wide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm where injection was received/tender touch at injection site, and redness at injection site 2 inches wide. This report was non-serious.
Patient developed syncope very soon after injection.  We helped  her lay flat and provided wet cloths and ice to keep her comfortable. We monitored her blood pressure and she walked out of store with help from parents about  1-1/2 hours later.
p/vax pt has redness & swelling in upper left arm. treated w/tylenol. in ER given benadryl
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication: Benadryl and Tylenol No concomitant medication reported   This case was linked to MOD-2021-103524 (Patient Link).
This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On unknown date shortly after the patient received the dose of ZOSTAVAX, she developed a "rash on the arm where the ZOSTAVAX was given." The patient sought medical attention by seeing the pharmacist and it was unknown if treatment or lab diagnostics studies were performed for the event. At the time of the report, the patient recovered from the rash on unspecified date described as "the patient was fine shortly after." The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Unusual feeling in arm after vaccination. the next morning she reports red blotches with swelling around the injection site and around bicep towards antecubital area. She reported to me in the morning on 9/24/16 and the swelling was decreased but the red blotches remain. 2 blotches about 4 square inches per blotch.
Chest pain - non-radiating. BPs 131/81 (pulse 74), 119/69 (pulse 67), O2 sat 100%.
Pt recvd vax & exp muscle cramping, liver twinging; lasted for 2 days; did not receive tx;
Angry red bumps on the back of my tongue still there but not as bright red now just pink and not nearly as big now. I've been rinsing with antiseptic. Please note that I was on an antibiotic when I got my vaccine
L Deltoid persistent pain and mild tenderness to palpation, onset with pneumococcal vaccine to L deltoid 4/27/09.
Lump; Itchy thigh; Red ring around itchy thigh; Diarrhea; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump), PRURITUS (Itchy thigh), ERYTHEMA (Red ring around itchy thigh), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (Lump), PRURITUS (Itchy thigh), ERYTHEMA (Red ring around itchy thigh), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache). At the time of the report, MASS (Lump), PRURITUS (Itchy thigh), ERYTHEMA (Red ring around itchy thigh), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Right thigh swollen, red. Patient fussy, slight fever, 99deg; Family Physician prescribed antibiotics. Red and swollen from hip to above knee (inner thigh to hip area); dx: cellulitis
Member had seizure around 1325 on September 19th. Member placed on his side and 911 was contacted. Vitals taken by Medical staff on site member was watched until paramedics arrived Member was taken to the hospital via ambulance.
Rash a day and a half after receiving the vaccination. Rash is on chest and back, and patient communicated itchiness. Patient has been self-treating by applying hydrogen peroxide to affected areas, and is still experiencing rash symptoms (6 weeks after vaccination).
Pt reported mild tachycardia within 15 minutes of receiving the injection with tingling in her legs. She returned to work and did not note the tingling again until the next evening. At that time, she noted tingling and a sense of weakness in her legs, though no manifestation of weakness (i.e. no falling down or legs giving out). Symptoms persisted through the 18th and 19th but were noted to resolve on the 19th.
I felt feverish, fatigue, body ache, muscle ache, and joint pain. I didn't have congestion, runny nose, cough or sneezing. I had a sore throat, cough, joint pain, 99.8 fever, congestion, chest pain. I got tested for COVID-19 on 12/27/2021 at my work hospital. The results came in this morning, 12/28/2021 for positive for COVID-19.
I got all the symptoms I had when I had covid-19 back in Nov.  I was just getting a little smell and taste when I got the J&J shot. After I got the shot, I got the headache, cough, loss of smell and taste, extreme fatigue, cold, aches, etc. I still do not have my smell and taste back.
Patient has had muscle soreness in arm where vaccination received and is still having difficulty moving and raising arm as of 7/7/18. There is no rash, redness, or swelling present.
Extreme pain at injection site.  Fever of 101 all night.  All over aches in my bones
Developed a rash on his right wrist, after so many months that itches and comes and goes.  Patient thinks it's from getting immunized with Anthrax because he never had it before.
day p/vax pt came to ER having suffered seizure, was admitted to hosp. did not suffer another seizure, no other illness detected during stay in hosp
Turned into a vegetable, full blown dementia; First dose hit her hard; Put her in bed for 24 hours a day; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day). At the time of the report, DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.    Treatment information was not  provided.  Before Vaccination although patient had mild dementia and was independent, cooked, cleaned, walked on her own. After 1st dose "all she could do was sit and rock in a chair"   This case was linked to MOD-2021-294412 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received on 24 Aug 2021 included no new information.
elevated fever 104.5 ear; fever broke 16APR94; no theraputic intervention;
Blister below the injection site; This case was reported by a other health professional via call center representative and described the occurrence of blister in a male patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, less than a day after receiving Twinrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Twinrix in an unknown arm and got a blister on the same arm a few inch below the injection site on the same day.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the fever, chills and headache to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, chills and headache after receiving Flu vaccine. This case is linked to case US2019046212, (same patient).
Information has been received from a 64 year old female consumer with diabetes and drug hypersensitivity who couple days ago, on 03-AUG-2009, was vaccinated with a single dose of PNEUMOVAX 23. Concomitant therapy included "allergy shot". It was reported that "after getting the vaccine" she experienced injection site reaction. The arm under the injection site became swollen and red and the muscle hurt. It was reported that she was taking BENADRYL and putting ice on the site and it has gotten much better. The patient did not seek medical attention. There was no laboratory diagnostic tests performed. It was reported that the patient was recovering at the time of the report. No further information is available.
headache, swollen lymph nodes, chills, sore, tiredness, knot on arm
15min after shot client began complaining of itching all over but no difficulty breathing. 25mg of benadryl given to pt. 5min later there was no change. Nurse stayed with client for another 10min and then client reported decreased redness, and itchiness. Pt stated that she felt good. After another 10min client was stable and released to personal vehicle.
Felt dizzy again; Dizziness walking around the house; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness walking around the house) and DIZZINESS (Felt dizzy again) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness walking around the house). On 22-Feb-2021, the patient experienced DIZZINESS (Felt dizzy again). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 08-Feb-2021, DIZZINESS (Dizziness walking around the house) had resolved. At the time of the report, DIZZINESS (Felt dizzy again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.   This case was linked to MOD-2021-026385, MOD-2021-026385 (Patient Link).
Inc temp 103-104 w/vomiting; Mom stated child "was sick allnight"; Seen in ER MD stated child had hx of tonsilitis, strep throat, etc. Did not feel illness related to immun possible viral infect;
The patient is a 59 y.o. male with PMH of afib not currently on anticoag (s/p successful DCCV in May 2021 and has been on off DOAC since that time), non-ischemic CMP w/ improved LVEF w/ medical therapy, CKD3a, HTN, valvular disease that improved w/ medical therapy and LVEF who presents with wheezing and dyspnea.   Patient felt in his normal state of health this past week (recently recovered from PCR proven influenza A infection). He awoke this morning and felt like he couldn't catch his breath. Felt audibly wheezy. Called family for a ride to the ER, but they were taking too long so he called EMS instead for concern of worsening respiratory status. Came in to the ED for evaluation. Upon arrival, he was tachycardic and EKG showed afib w/ RVR. Vitals otherwise stable. Given neb with improvement in respiratory status. Labs w/ mildly elevated BNP, so he was also given lasix 60 mg IV alongside methylpred IV given his wheezing. Stable on RA. His viral panel screen did return w/ a positive COVID PCR. Started on a dilt gtt as well for his RVR and admitted to the GM service. Patient tells me that he has been compliant with his meds. Weight stable, but does endorse more orthopnea. No fevers, chills, sweats, n/v/d, change in taste/smell. No recent travel. No cp or palpitations. Has been coughing today which is new. Never smoker. No hx of asthma either.
her Mother-In-Law became symptomatic; She exposed to Daughter-In-Law on Friday 10SEP2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (her Mother-In-Law became symptomatic), EXPOSURE TO SARS-COV-2 (She exposed to Daughter-In-Law on Friday 10SEP2021) and PRODUCT DOSE OMISSION ISSUE (trying to decide if she should receive the second dose today 13SEP2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPOSURE TO SARS-COV-2 (She exposed to Daughter-In-Law on Friday 10SEP2021). On 13-Sep-2021, the patient experienced COVID-19 (her Mother-In-Law became symptomatic). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (trying to decide if she should receive the second dose today 13SEP2021). At the time of the report, COVID-19 (her Mother-In-Law became symptomatic), EXPOSURE TO SARS-COV-2 (She exposed to Daughter-In-Law on Friday 10SEP2021) and PRODUCT DOSE OMISSION ISSUE (trying to decide if she should receive the second dose today 13SEP2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307321 and 2019SA307322 (same reporter).  This case involves a 72 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the Left Deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency and route were unknown). The temperature excursion for the GARDASIL was found to be unsupported with in-house stability data. No adverse symptoms reported. Action taken and outcome were not provided. Additional information has been requested.