chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash developed on left shoulder; Rashes appeared at waist line, and hip with itching/ Rash itches; Rash has bumps; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 23Mar2021 at 12:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles as teenager one time and remained dominant and asthma and Penicillin allergies. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and nature plus gold vitamin all are received for unknown indication and since unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 13:00, 1 week after shot the patient experienced red rash developed on left shoulder. On an unknown date in 2021, 1.5 to 2 weeks later the patient experienced rashes appeared at waist line and hip with itching. Rash has bumps, rash itches at night. Therapeutic measures were taken as a result of adverse events and included treatment with over-the-counter creams and meds did not help or do antihistamines. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red rash, itching and raised rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination was updated to 62 years, Penicillin allergy was updated to relevant medical history, not past drug event and updated narrative "1 week after shot" was added and "meds did not help but do antihistamines" was updated to "meds did not help or do antihistamines".
had a severe allergic reaction/having a rash yesterday; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history included drug allergy to sulfa medicatoins. The patient's concomitant medications were not reported. On an unknown date the patient had a rash and her HCP stated she had a severe allergic reaction and not to get the second dose of the vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
nauseous, vomited, faint, then ambulance went unconscious within 15 minutes of vaccine.  Then one week later inverted T waves and hospitalized, recovered then about a week or two later Transient ischemic attack unable to speak recovered.  then have been having abdominal pain/pelvic pain.
Next morning I woke up, neck was sore and the lymph nodes across my neck were painful and swollen again. Was extremely tired that weekend after the booster. I was in the hospital with my son at that time, so I didn't call anybody about it. May have taken some Aleve or my meloxicam for the pain. I don't remember exactly but it took about 2 weeks for the swelling to go away.
Facial Flushing and warmth. Complained of itching feeling in lips and mouth. Given 50mg BENADRYL orally at 10:07. Complained of chest pressure, nausea. Given 80 mg SOLUMEDROL IV at 12:10, ZOFRAN 4mg at 12:10, TORADOL 30mg at 13:16.
received the vaccines which were exposed to below freezing temperatures; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 03-OCT-2023, the patients received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: received the vaccines which were exposed to below freezing temperatures).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 04-OCT-2023 Nurse states that Flulaval was exposed to 29F for 3 hours and was then administered to some patients yesterday, 03 October 2023. The patients received a dose of Flulaval QIV after exposed to 29F, which led to incorrect storage of drug. The reporter consented to follow up.
Burning up; Shivering; Feverish 104.6; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6). At the time of the report, BURNING SENSATION (Burning up), CHILLS (Shivering) and PYREXIA (Feverish 104.6) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from an administrator refers to multiple patients of unknown ages and genders. On an unknown date in 2016, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD (lot # L017140, expiry date: 13-NOV-2016; lot # L051101, expiry date: 17-JAN-2017; lot #M0011660, expiry date: 08-SEP-2017; lot #M004889, expiry date: 25-JUL-2017, lot #L042817, expiry date-26-APR-2017, lot #M006107, expiry date:01-AUG-2017 (route: subcutaneous) throughout the temperature excursion beginning 06-JUL-2016 (incorrect product storage). The outcome of the events was unknown. Additional information has been requested.
Numbness/tingling in left arm and hand. No other symptoms. Baseline BP is elevated at home & BP elevated here, asymptomatic. Neurological exam benign. No fever, no swelling, respiratory exam benign. Stable s/s on exit from clinic
got the flu really bad; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional social media.  This case involves a patient of unknown demographics who got the flu really bad (Influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date of 1973, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported got the flu really bad (Influenza, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for flu, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Nurse reported an adverse event 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again 100 adult male patients were involved.  Treatment information was not provided.  This case contains information for 77th of 100 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient presented with signs and symptoms consistent with cellulitis of the LUE after administration of the flu vaccine 2 days prior. There was a well-demarcated, raised area with erythema and increased warmth approx 10in wide and 5in high. TTP. Symptoms started that morning and was seen at approx 2:30pm. She was treated with cephalexin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 4 (four) times a day for 7 days.
Mom reports pt got siblings vaccines MA (Medical Assistant) does not feel so. 1 yr old due for MMR, varicella, hep A. 2 yo due for Hep A. ? Vaccines switched. Offered mom 1yr to get MMR + Varicella again. Did on 8/30/21.
Patient's arm is swollen and red and itchy. Patient already took Tylenol for her fever. I advised patient to take Bendryl.
Child described to me the following: feels sick and icky, tummy hurts. As the parent, I observe itchy skin on belly, child keeps itching. Child has about 12-15 sores on legs, arms, behind neck and is itching a lot. Mucus draining, sneezing, runny nose. Child is extra-hyper since the day of the vaccine. For example, when I am reading a story to him he is moving his head all over and acting odd for my child.  Having trouble focusing more than usual. Cranky and irritable. Increased arguments with siblings.
-- Myocarditis, i.e. inflammation of the heart myuscle and area surrounding the heart -- Inflammation/pressure around my ears/head, leading to headaches/dizziness/disorientation  I have confirmed this with both my primary care doctor and my cardiologist. It has been 3 weeks and I am not feeling better at all. I have a pounding heartbeat, and a pounding headache.  At this point the vaccine has been worse than the disease itself. I hope you stop misleading the public and communicate that myocarditis and severe inflammation IS 100% A SIDE EFFECT THAT IS CAUSED BY THE VACCINE RESPONSE. I know because I am experiencing it, and you've ruined the last 24 days of my life. Thank you.
After patient received vaccine and sat down in waiting area he proceeded to lose consciousness and bump his head on the side table. He reported no injuries and was feeling fine approx 30 minutes later.
This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with (oka/MERCK) VARIVAX (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Soreness in left arm, fever with chills, aches, and shakes lasted most of the night after the dose. The next day, had mild chills and moderate aches. Symptoms improved and I was mostly able to do regular daily activities by the afternoon. Fever broke the 2nd night. I have felt fine since.
Sneezing; swollen, itchy eyes; swollen throat, difficulty swallowing, rash
Increasing pain, weakness, numbness. Pt felt was related to existing lumbar issue, but continued to worsen so contacted MD. Continued pain medicine and started physical therapy.
Vision problem; Dizziness; Distorted vision; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's parent) reported for a 14-year-old female patient (reporter's daughter) that: A 14-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 12Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her daughter received the first dose on 12Jun2021 after getting the first dose her daughter experience vision problem, dizziness and distorted vision. "Not just the dizziness but she was getting distorted vision also." And the reporter was asking if this is one of the side effects of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information was expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: FK9894) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: 027EZZA), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9264), in left arm and on 27Feb2021 as dose 2, single (Lot number: EN6201), in left arm for covid-19 immunisation. The patient's relevant medical history included: "slightly overweight" (unspecified if ongoing), notes: BMI about 25 so slightly overweight; "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: NATURE MADE VITAMIN D3, start date: 01Sep2020; D MANNOSE, start date: 01Sep2022; VIACTIV [CALCIUM], start date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 25, notes: BMI about 25 so slightly overweight; SARS-CoV-2 test: (22Dec2022) Negative, notes: testing negative on Thursday, 22Dec2022; (30Dec2022) Positive, notes: tested positive again on Friday, 30Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300071007 Same patient/vaccine, different dose/event;
This patient received HBV, in the right deltoid at approximately 2:00 PM on 11/16/00. At approximately 6:00 PM the patient noticed his right lateral palm was numb "like paresthesia" numbness and tingling has continued.
Following vaccine, developed a large lymph reaction (softball sized) in the left axilla area.  Felt feverish and ill for a few days and it took about 4-5 days for it to go down.  Following that developed left breast pain, radiating to 6:00.  Lasted for 10+ weeks (waited to see a provider through 2 menstrual cycles to confirm it was not hormonal).  No lump located at 6:00, but sent for a diagnostic mammograms and ultrasound.  Located a small lump at 1:30, underwent biopsy and it was diagnosed as dense fibrotic stroma.  Was required to go back in 6 months for repeat U/S to confirm no growth or change.  Also saw a Breast Oncologist who reported nothing can be done about pain--- which continues to this day.
On day 10, large oval rash, hot, red, swollen and itchy. Dr advised to use topical antihistamines
doses given after temperature excursion; The vials had 20 mins of temperature excursion; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion). In 2021, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The facility had 20 minutes of excursion in the freezer with the Moderna COVID-19 stored vials. The excursion was on Sunday and the other health care professional was not informed until the doses were vaccinated.   Reporter did not allow further contact
Pt claims that about 4  hours after receiveing her 1st covid shot, she developed Shortness of breath. Denies any hives or facial swelling. She contacted emergency room, they told her to come in. She didn't want to.  The sob resolved on its own.
First night I had night sweats and chills and the next morning I had aches all day and a general weak feeling.
stage 3 Chronic Kidney Disease; igA and igG are elevated as well as her polyclonal antibodies; igA and igG are elevated as well as her polyclonal antibodies; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with stage 3 chronic kidney disease (CKD). She clarified she had no reaction to the vaccine and that she had the intention of getting the 2nd dose. Her healthcare provider (HCP) also recommended that she get the 2nd dose, but delayed it due to being diagnosed with CKD on an unspecified date. The patient mentioned that she had done several tests and found out that her igA and igG were elevated as well as her polyclonal antibodies on an unspecified date. The patient asked if her high polyclonal antibody did suggest that she had a good immune response to the 1st dose. She also asked that since both her igA and igG were elevated, if those showing too much of an immune response already and did that mean that her overreacting to the vaccine or the CKD. The patient asked if she still needed to receive the second dose even with the high polyclonal antibody found on her test. The patient further asked what would be the recommendation, since she was already way past beyond the recommended 3-week interval of the 2 doses. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Mother presents to clinic today on 01/13/2016. States she discovered the patients left arm to be swollen, reddened, taut and warm to touch yesterday on 01/12/2016 at 12pm. He also developed a fever of 99.8. She administered "Nurofen" and his fever resolved. She also applied an ice pack to the left arm for 5 minutes.  Currently, mother denies noticing any symptoms of fever, however he is complaining of mild pain on his left arm. Physical assessment shows let arm to be reddened, swollen, taut and warm to touch. Mother denies bringing him to ER or UC. Advised to bring patient to UC or PMD for evaluation of left arm.