chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning sensation from rash; Bumps where rash has occured; Reddish rash from toes to torso; Rash from toes to legs; Itchy from toes to legs; sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and RASH (Rash from toes to legs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 12-Mar-2021, the patient experienced PRURITUS (Itchy from toes to legs) and RASH (Rash from toes to legs). On 13-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured) and ERYTHEMA (Reddish rash from toes to torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch and Rash, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and RASH (Rash from toes to legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event reoccurred after being resolved when treated with Benadryl.
Both hands were pink; This is a spontaneous report from a contactable consumer (patient, reported for self). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date (on Thursday, it was about 12:00pm), as single dose for COVID-19 immunization. Medical history included redness. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date: UNKNOWN) administered in arm right on an unspecified date (on Thursday), as single dose for COVID -19 immunization (because she doesn't want to get sick) and stated both her hands and palms were very red color, like beet root, she had problems with her brain and experienced discoloration of her arm. Reporter stated the first time when they gave her the shot, both of her hands went red and it just spread through her blood and both of them became red. Reason for no lot number: Reporter stated she lost the application with that on it. On an unknown date, after second dose of vaccine the reporter stated her both hands were pink, just a little bit. Reporter stated she still has a little bit of redness, but its fine, she actually has it from school or kindergarten, the redness. She confirmed that she has recovered. Reporter stated no its not from the vaccination, the blood vessels, its a norm from her, it's from school. Outcome of the events was recovered.   Information about lot/batch number has been requested.
Received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015m20a and 011a21a) for COVID-19 vaccination.     The patient's past medical history included Alcohol use and Placenta previa (Live, pre-term birth). Concurrent medical conditions included Gestational diabetes and Cerebral palsy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 31-Oct-2020 and the estimated date of delivery was 14-Jul-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient was subjected to ultrasound scan two times.
Pt had received a dose of Moderna on 4/9/2021. Pt is incarcerated. Unable to check accuracy of information. Received a dose of J&J while at clinic.
This spontaneous report was received from a patient's wife and was assigned manufacturer report number 2016US015482 for XTANDI on 28-NOV-2016, referring to a 67-years-old male patient with pain (details unknown). The patient received XTANDI, capsule, (160 mg, start/stop date unknown) (lot# reported as 1539683PC; 1543982PC; 1553886PC), orally, once daily, for prostate cancer with metastasis. On an unspecified date, the patient developed loss of appetite, joint aches, fatigue (first episode), headache and there were no changes since starting on XTANDI. In July 2016, the patient experienced fatigue (second episode), hot flashes (ongoing), bruising (ongoing) that came and went and patient seemed depressed sometimes (ongoing). On an unspecified date in October 2016, the patient developed fatigue (third episode) (ongoing). In October 2016, XTANDI dose was reduced to 120mg daily due to the event fatigue. On 07-NOV-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not reported) and influenza virus vaccine (unspecified) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On unknown date in November 2016, patient had soreness in his arm and achiness at the injection sites. No lab test was performed. At the time of reporting, the patient did not recover from soreness in his arm and achiness at the injection sites. Action taken with XTANDI due to the event was unknown. The events Soreness in the arm and Achiness at injection sites were not related to XTANDI. The causality between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), influenza virus vaccine (unspecified) and the events were not provided. Additional information is not expected.
Fever 102-103 - No other symptoms - 3 day after vaccine viral illness.
Pt recvd 3 doses of Engerix-B & failed to sero-convert; Booster dose of vax is planned;
Client was fully vaccinated with Moderna vaccine for Covid on April 14 and May 15, 2021.  On 7/23 she was asymptomatic but decided to get tested because she travels by car for work within a tri-state area.  PCR test was positive on that date.  Reported because this is a case of breakthrough Covid in a fully vaccinated individual.
Initially left chin and lower cheek were numb/tingling/Numb feeling spread up left side of face and also to left leg and left arm; Initially left chin and lower cheek were numb/tingling; Nausea; Slight dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration in arm left on 21Mar2021 at 13:15 (at the age of 55-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included prone to migraines. The patient had no known allergies. The patient was not pregnant at time of vaccination. Allergies to medications, food or other products was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications received within 2 weeks of vaccination included dexlansoprazole (DEXILANT) taken for stomach acid issues. Previously patient received omeprazole for stomach acid issues. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 14:00, the patient experienced initially left chin and lower cheek were numb/tingling/ Numb feeling spread up left side of face and also to left leg and left arm, nausea and slight dizziness. This occurred about 40-45 minutes after vaccine. Called CVS and primary doctor, both advised going to emergency room. In a 13-hour emergency room visit had CT scan, blood draw and MRI as well as physical evaluation. No stroke related concerns identified. Post emergency room, left side facial numbness remains, all other issues have subsided. The events resulted in emergency room/department or urgent care. The reporter considered the events as non-serious. On 21Mar2021, the patient underwent lab tests and procedures which included blood draw, CT scan, MRI and physical evaluation, all were resulted as no stroke related concerns identified. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
This was a booster shot. The area below the shot became read the second day and was raised with heat.  On the third day the area was larger and there is a reaction to the area around where the shot was given.  This area is raised a little and red.  Itching is only on the larger area. I had a similar reaction to the first shot a week later.  These symptoms lasted 5 days.
Had bloating; Severe stomach/abdominal pain; Severe stomach/abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 24Apr2021 at 14:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. On 26Apr2021 at 04:00, the patient experienced bloating and severe stomach/abdominal pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bloating and severe stomach/abdominal pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. On 13th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. This case is for 2 of 2 linked patients. Additional supportive information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022133245:Same reporter
Round flat pink/red circular area at the site of injection. Has enlarged to 2 1/2 cm over 1 wk. Slight warm to touch, but not tender.
Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 21Feb2021 (Lot number: EN5318) at the age of 56 years as dose 2, single and administration date 31Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary embolism" (unspecified if ongoing), notes: Recurrent Pulmonary embolism. Concomitant medication(s) included: XARELTO taken for pulmonary embolism. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills".  Additional information: Prior vaccinations (within 4 weeks): none.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101699575 same patient/drug, different event (Booster dose).
ALMOST DIED; SOBBING FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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 subject experienced almost died, and sobbing for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from almost died, and sobbing for 3 days. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
At 600 p.m. his throat started tightening up and stayed tight until the following morning wound 1200 (noon).
I contracted COVID-19 on 05/23/2022 with symptoms of headache, sore throat, ear ache, and body aches. I did not seek medical care. I was ill for 6 days before my symptoms began to resolve. I was fully recovered after 7 days with no lingering symptoms.
On 3/5 woke up with chills, achiness all over, stomach ache, had a fever (did not take temp) and total fatigue. Symptoms lasted for 3 days until 3/7. By the 3rd day it was just the stomach that bothered her. TUMS did not do anything. Feels fine today.
I had been to the doctor and my blood pressure was very high, which is unusual for me. I began feeling heart palpitations and random pain in my chest. Over the course of the next week, that all kind of came and went. I had been suffering through my third sinus infection. I had fractured my knee in mid-December. I had initially been taking ibuprofen for the swelling in my knee. On 02/03/2023, I was at a spinning class and my heart rate was up at 105 BPM before even peddling. I eventually went to the emergency room because I was having pain in the left side of my chest and in my back by my scapula. They did an x-ray of my heart and other testing. It turned out to be an accumulation of ibuprofen. My blood pressure was at 180. They sent me home after around two hours and also suggested that I may have an ulcer from the medication I had been taking. They advised that I stop taking ibuprofen and prescribed something to line my stomach and esophagus. I don't feel that any of these events are related to my COVID-19 vaccine, but I suffer from tinnitus, and I do feel that it has gotten worse since my fourth dose.
pt states that her left arm was sore for about 4 days after getting the covid vax.  The next day she developed severe brain fog and fatigue.  She also had chills no fever, SOB, lost of taste, and nauseated.   These symptoms lasted one week.  The second week she began to have dizziness, lightheadedness, change in voice to where she has trouble speaking.  Some days she cannot taste.  She has hair loss and red rash bumps on left leg, chest, and back.  Pt states she had a covid like illness from Feb 2019-mid summer 2020 and she is having the same symptoms now that she had then. Pt contacted her PCP regarding her symptoms.  Pt says she is much better but still has brain fog periodically and her voice is still not normal and she can hardly speak.
Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husband 'I don't feel well'. Immediately my eyes rolled back and convulsions started. Then I passed out. EMTs were called over to car and started to administer oxygen. I woke up about 6:30pm cognizant of surroundings. BP was normal. No fever, no rash, no chills. I was just tired. Then 2 hours of vomiting started. Last vomit about 8:15pm in ambulance. EMT unable to administer IV. After waiting in ER waiting room for 45+ minutes, a bed was available (around 9pm). ER doctor gave me ondansetron ODT 4mg Once. Released at 10:12pm to go home. Next 3 days symptoms of lightheadedness and dull headache.
Dose 2 within four hours into her shift running 101. fever 103.5 fever 3-4 days. Brain fog and new diagnosis of asthma since having COVID March 2020. Joint pain and constant fatigue and was very active and 12 hours of sleep from 6 hours a day. One shift a week sleep 2-3 days on and off. Constant headache. Used to work three 12 hours a shift or 40 hour work week and unable to perform at this level since vaccinations. Seem pumalogy since the vaccination and the diagnosis of Asthma was diagnosed in 2021 after the offices re-opened. Urgent care in 2021. X-ray and referred to pulmonology, was put on asthma medication and was advised with note that she had difficulty with wearing a mask. Advair, Singular and Trilogy. X-ray and referred to pulmonology, was put on asthma medication and was advised with note that she had difficulty with wearing a mask. X-ray, EXG, dye contrast, blood clots test, and put her on Trilogy Summer 2021.
pt recvd vax & devel fever & generalized raised bumpy rash w/in 24hrs of vax;It was noted that the rash was not varicella-like;2 pts were reported & given WAES95110709 & 95110710;no further details were provided;
Severe tinnitus in both ears,  hissing, high pitched whine Nausea Chills Body aches  Joint pain in hips and knees  Headache Fatigue  Diarrhea  Malaise
Had shingles, had the shots to/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles, had the shots to/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and had shingles 5 years ago.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
itching; noticeable discomfort; small rash-like bumps; swelling, injection puncture (raised edges, "Donut"; This is a spontaneous report from a contactable consumer, the patient. An elderly male patient of an unknown age received second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ER8731) via an unknown route of administration at Arm right on 13Apr2021 at 07:45 as single dose indicated for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: Unknown) via an unknown route of administration on 23Mar2021 at 07:45 as single indicated for COVID-19 immunisation. The medical history of the patient included Atrial fibrillation (Aib), and penicillin allergy. The patient did not take any concomitant medication. The patient did not receive any other vaccine in last four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-10 since having the vaccine. On 15Apr2021 (Thursday), the patient started to notice swelling, by Friday or Saturday, noticed change in injection puncture which had raised edges like a Donut. By Tuesday 20Apr2021, small rash-like bumps appeared, which had itching and noticeable discomfort. The treatment given for the events was unknown. The clinical outcomes of all the events were not recovered at the time of this report.   No follow-up attempts are possible; No further information is expected.
COVID-19 rapid POC test positive; COVID-19 rapid POC test positive; the amount of vaccine given as 1 cc; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a 52-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 17Dec2020 at 1 mL, single dose for COVID-19 immunization. Medical history included ongoing hypertension diagnosed when she was 33 years old. There were no concomitant medications. The patient got the vaccine on 17Dec2020. The patient stated that the amount of vaccine given was 1 cc. She took a COVID-19 rapid POC test on the 28Dec2020 and tested positive. She wanted to know if she should have the second dose of the vaccine. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.