chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) at age 84 years (as reported), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included warfarin sodium (COUMADIN). The patient previously received shingles vaccine (believes it was more than four weeks before getting the COVID vaccine). It was reported that the day after (26Jan2021), the patient experienced sore arm like everyone else. The sore arm has gone away, but does not know what day it went away. The day after the vaccine the patient had a swollen face (26Jan2021) and today it is worse; it is more swollen. On 01Feb2021, the patient experienced an itchy nose and sneezing. The outcome of the event sore arm was recovered on an unspecified date, the event swollen face was not recovered, while unknown for the events itchy nose and sneezing.  Information on Lot/Batch number has been requested.
pt devel nodule @ the inj site following vax;pt was treated w/ATB
Swollen, erythemotous arm, warm to touch. Beandryl, Motrin had no improvement. Severe local reaction to DTaP.
35yo G2P2 s/p term spontaneous vaginal delivery  @ 38 wks gestation. On postpartum day #2, complained of pain and palpable varicosity behind lateral left knee. Doppler studies revealed superficial venous thrombosis, no DVT. Patient discharged on postpartum day #2 on prophylactic Lovenox daily. Patient Rh-negative - received Rhogam 1/22/21 during pregnancy and again  after delivery. Otherwise, had no maternal complications this pregnancy. After the fact, pt notes that she has a sister with a history of unprovoked DVT in the past.
COVID arm; a red rash underneath of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Red rash, Vaccination site pain and Vaccination site rash.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (COVID arm) and VACCINATION SITE RASH (a red rash underneath of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Carcinoembryonic antigen: other (Inconclusive) 3.7 ng/ML.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   This case was linked to MOD-2021-080891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Email Response On 25-May-2021: No specific follow-up information recorded.
This patient was admitted to Medical Center at 37 weeks gestation. History of prior cesarean x 3. She reported low back pain and her stomach tightening but no abd pain. The patient had a prolonged fetal heart rate deceleration while in triage. Biophysical profile was 2/8. Emergency cesarean section performed. Uterus full of 300-400 cc port wine colored blood upon hyterotomy. Abruption suspected. Infant was rescucitated but was pronounced deceased a few hours later.
Went to the emergency room experienced chest tightening, shortness of breath, stomach pain, nausea. Ambulance was called they checked my vitals and monitored me for twenty minutes, determined an irregular EKG and took me to the nearest hospital. The hospital checked vitals and determined I was having an allergic reaction to the vaccine.
suspected vaccination failure/I got the shot and still got it real bad; still got it real bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and still got shingles really bad. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
groggy night of vaccine; 6 yr old received Flublok which is licensed for 18 yrs and older; very tired; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 years old female patient who was very tired, had groggy night of vaccine and received flublok which is licensed for 18 yrs and older while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient had no medical history, concomitant disease or risk factor.    On 21-Sep-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine lot UJ887AA (with an unknown dosage, strength, formulation, expiry date) via intramuscular route in unknown administration site for Flu.  On 21-Sep-2022, the patient had developed a non-serious events groggy night of vaccine (somnolence), very tired (fatigue) and received flublok which is licensed for 18 yrs and older (product administered to patient of inappropriate age) latency same day following the administration of influenza quadrivalent recombinant vaccine. Patient reported that Back to baseline by following morning.  There were no lab data/results available.  Action taken - not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved in September 2022 for the event groggy night of vaccine and for the event very tired, was Unknown for the event 6 yr old received flublok which is licensed for 18 yrs and older .  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 the 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.
he got a mouth sores or the cancer; He got a mouth sore; Couldn't eat nothing; the vaccine gave him like immunity stress or something; my shoulder stiff or something; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 29Apr2021, as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. On an unspecified date, the patient got a mouth sores or the cancer, couldn't eat nothing, the vaccine gave him like immunity stress or something, shoulder stiff or something. Reporter stated that We both complete our 'immunity' (Further clarification was unknown), the second dose was on 29Apr2021, it was stated that of course he had some like side effect but the main thing was after like a week, five days to seven days, he got a mouth sores or the cancer, which he never get before, the reporter don't know if this was related to the vaccine or not. It's like so stressful, like the first month he couldn't eat nothing, it was stated that had to make the food like very soft and then the doctor put him on the antivirus medicines (Further clarification was unknown) and it's getting little better, so he could eat right, after completing the medication after a week, it came back again, he couldn't eat nothing, now it's getting better but some-times like (voice not clear) and 'here and there' they don't know what's wrong, he never had this in his life so reporter wanted to know is this related to the vaccine or maybe the vaccine gave him like immunity stress or something. His (incomprehensible voice), looked like a cancer (Since reporter was unsure, hence cancer was not captured as event). Anyway, they put him on an antiviral medication (treatment) or whatever. The doctor came out helpful that is why reporter felt like a (in-complete sentence). The event Neoplasm malignant was considered as serious (Medically significant). The outcome of the events was unknown.   No further information was provided.
Complaints of pain in left arm beginning day of vaccine then becoming what patient described as debilitating pain in arm, requiring visit to an urgent care center 8 days after vaccine. Temp 100, no redness/swelling. Was diagnosed and treated with possible cellulitis.
Patient developed a rash on her elbows and blisters on her lips 3-4 days after getting her Moderana Vaccine #1. She tried benedryl cream orginally which helped a little with itching. She was evaluated 3/30/21 for continued rash and itching with redness around her nose and corners of her mouth. Provider noted red spots on her arms, anterior elbows, chest and hairline face/neck. She was started on prednisone. She was seen again 4/8/21. She had been feeling better after taking the prednisone but after being off it for a few days, symptoms returned. She noted some lip swelling to her upper lip. She also had her itchy rash again inside her elbows, and itchy almost blistery rash on chest with hives on her neck.  No SOB, trouble breathing or swelling of tongue or throat. She was started back on prednisone and betamethasone cream which did help. Pt was reevaluated 6/29/21 by her primary provider and is doing much better but continues to have some irritation on her chest and her hands but much better. PCP request VAERS report be filed.
Initially, had pain and soreness at the injection site. Within 12 hours, developed a low grade fever (99.6) and fatigue. At around 8pm started to feel dizziness and by 9pm was experiencing severe vertigo (feeling like the room was wrenching violently to the right, not just spinning) and near constant dizziness. I was advised by the nurses who administered the vaccine to "over-hydrate" which I have been doing since leaving the Vaccination Pod; hydrating has had no positive effect on the vertigo.
little bumps all over her body that started on her hand after the first dose.  Between doses she noticed more bumps on small of back and chest. After the second dose they came out on her arms, entire back, torso, legs, a few on her forehead; itches really really bad; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She received the second dose on 18 March 2021. She reports breaking out in little bumps all over her body that started on her hand after the first dose. Between doses she noticed more bumps on small of back and chest. After the second dose they came out on her arms, entire back, torso, legs, a few on her forehead.f It itches really really bad. She took some Benadryl and this morning there is still a little itchiness. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of little bumps all over her body that started on her hand after the first dose. Between doses she noticed more bumps on small of back and chest. after the second dose they came out on her arms, entire back, torso, legs, a few on her forehead, itches really really bad. The outcome of the event little bumps all over her body that started on her hand after the first dose. between doses she noticed more bumps on small of back and chest. after the second dose they came out on her arms, entire back, torso, legs, a few on her forehead was unknown and itches really really bad was not recovered.  Information about the lot/batch number has been requested.
Dizziness when the getting the vaccine injected; Her arm swelled up; Soreness of arm; She developed a big hard lump in her injection site; Injection site was painful.; She had muscle pain all over her body; Headache; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site) and VACCINATION SITE PAIN (Injection site was painful.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         The patient didn't take any medications to alleviate their symptoms.  The patient post receiving the vaccine experienced the huge lump in their arm lasted about 3 weeks.  No Concomitant product use was reported.   This case was linked to MOD-2021-180135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up was received on 27-May-2021 and contains outcome of the event.
patient called reporting a rash at injection site today (date 8) patient is not signed up for vsafe.
Patient taste was not lost but most things did not taste right; Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well; This spontaneous case was reported by a patient and describes the occurrence of LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well) and TASTE DISORDER (Patient taste was not lost but most things did not taste right) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ENZALUTAMIDE for an unknown indication.    No Medical History information was reported.   On 22-May-2020, the patient started ENZALUTAMIDE (Oral) 160 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2020, the patient experienced LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well). On 22-Mar-2021, the patient experienced TASTE DISORDER (Patient taste was not lost but most things did not taste right). The last dose administered for ENZALUTAMIDE (ENZALUTAMIDE) was on 01-Sep-2022. At the time of the report, LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well) outcome was unknown and TASTE DISORDER (Patient taste was not lost but most things did not taste right) had not resolved.  No concomitant medication information was provided. On 01-Sep-2022 the patient had been advised by the doctor to hold Enzalutamide for 3 months due to unknown reason. No treatment medication were provided.
Dizziness episode lasting about 30 seconds. I was seated, so I don't know if I'd have been able to stand w/o falling/fainting.
Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Fever lasting more than 2 days.  Average temperature 102.7 Sore throat.  Abdominal Discomfort
Patient, received immunization, proceeded to post-immunization section for 15 minute observation. RN and EMT personnel noticed that individual appeared to lean in chair and then leaned forward as if experiencing dizziness.  RN approached individual at which time she appeared to be on verge of fainting, and sounded incoherent, her pulse was at 45, and she was dizzy, at which time an Epinephrine pen was utilized. As patient became more coherent she indicated she felt nauseous and proceeded to vomit. She was monitored by EMT and RN for about 30 minutes and was offered further medical assistance which she declined. Patient indicated that she had history of experiencing dizziness after a previous TB immunization.
about 18 hours after vaccination, I felt feverish and had chills. 24 hours after vaccination, the fever reached 103.5 degrees.
Pt reports severe chills starting around 3-4am. Symptoms then changed to pain, specifically in her joints. Symptoms are improving at time of call (1010am), but still lingering.
Case number PHEH2015US017927, is an initial spontaneous report from a pharmacist received on 11 Sep 2015. This report refers to a 45 years old female patient. Medical history and concomitant medications were not reported. On 10 Sep 2015 the patient was vaccinated with FLUVIRIN PFS (batch number: 15754P) that was out of temperature range at 34 F for 10 minutes. No adverse event was reported.
Received PPD followed by Varicella; when needle removed from left deltoid, patient became limp and jerking motions, skin cool and clammy.  Blood pressure: 80/50.  Thready, weak.  After 2 min. patient alert pulse 8, blood pressure 90/60.  After 5 min, alert pulse 72, blood pressure 100/80.
vaccine had expired on 08-Mar-2020 but was administered to a patient; Initial information received on 25-Mar-2020 regarding an unsolicited valid non-serious case from a pharmacist in the.  This case involves a 64 years old female patient who was vaccinated with a expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot: U5882AA, expired on 08-Mar-2020) on 25-Mar-2020, via an intramuscular route in the left arm.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient did not experience any adverse event.  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.
The pinched nerve in my left arm is a pinched Ulnar Nerve. From the elbow down to the pinky and ring finger have been very painful since August. This is a numbness and tingling and then pains when I have to bend my elbow; like when I have to brush my hair or teeth anytime it is bent for a long time it creates pain.  I was given Prednisone to try and help and was sent to occupational therapy as well for my hand which did not work. I was sent to neurology to do a nerve conduction test which came back normal. I was then sent to an orthopedist to do an ultrasound on my arm and area to see what is causing the pinched nerve. They gave me Voltaren Gel 1% to help with this as well. I am still having this issue today. The ultrasound showed enlargement of the nerve and the muscle around the area that was is pain and I am having a following up this week on that.
Right upper arm swollen from axilla to below elbow. Mother states redness has decreased after Ibuprofen administered and cool compresses applied. No history of reaction.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-MAY-2013 the patient was vaccinated with a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown). The Healthcare worker reported that RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
January 7th: Sudden onset of hives, intense itchiness with redness, swelling went to urgent care next day perscribed otc antihistamines 2xqd, benadryl to assist at night.. currently on 1 claritin in am a 2 benadryl at night. has improved significantly but still persists