chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First 24 hours just mild pain at the injection site. The second night after the vaccine had moderate to severe pain around injection area that woke me from sleep. This persisted the following day and I began to have some systemic symptoms including decreased appetite, mild body aches and fever (100.5 F). The next morning (3 days after the injection) I awoke to find erythema and swelling around the injection site which progressed through the day, this was accompanied by more severe myalgias, decreased appetite, joint pains, moderate to severe headache, neck stiffness, and general malaise. I also had a higher fever, highest recorded was 101.3, but clinically I believe may have been higher at some point. Today is day 5 after the injection, the systemic symptoms have decreased in intensity with steroid (solumedrol 125mg IM on 11/30/10, and prednisone started today). Have developed some mild facial erythema today (after steroids) and the injection site continues to be erythematous and tender to touch.  I am a physician myself and am interested in any follow up information regarding similar reactions if they have occurred in the past. I read less than 1% of people have a more severe reaction to the PPSV is this still accurate. It should also be noted that I got the meningococcal vaccine on the other arm the same day and that has not produced any tenderness/redness etc.
had cold sores (oral herpes); This case was reported by a consumer via other manufacturer and described the occurrence of cold sores in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) solution for injection (batch number unknown, expiry date 30th April 2022) for asthma and atopic dermatitis.   Concurrent medical conditions included asthma and atopic dermatitis.   On an unknown date, the patient received the 2nd dose of Shingrix and Dupixent (subcutaneous) 300 mg weekly. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. The action taken with Dupixent was unknown. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The age at vaccination was not reported. On an unknown date, the patient started taking dupilumab injection liquid (solution) at 300 mg dose every other week (strength: 300mg/2ml; with an unknown batch number) and varicella zoster vaccine RGE (CHO) (with an unknown dosage, frequency, indication, route and batch number).  In the context of COVID19 crisis, the batch number was not requested. The patient reported that she had adverse reaction, onset and latency was unknown while on Dupilumab and after her second varicella zoster vaccine. The patient experienced dry red patch quarter size to injection site, injection site rash, injection site erythema twice over the last month that resolved on its own.  The patient also had cold sores (oral herpes) unknown date in 2019 and latency was unknown a couple of times over the last year. The patient got quarter size spots on her belly from the syringe that was why she wanted to try pen. On 25th June 2021, the product technical complaint was initiated for dupilumab and investigation was still in process. No lab data was reported. It was not reported if the patient received a corrective treatment or not. It was unknown if the reporter considered the cold sores to be related to Dupixent. The consent to follow-up was requested.
pt recvd vax; petechia on lt wrist on extension surface of elbow;lt knee pain & limp;sxs started approx 7 days p/ vax;
19AUG-23AUg fever to 102.5max, sl runny nose;22AUG97 rash red blanching macular;23AUG97 rash w/watery non bloody stools;24AUG97 fever resolved,rash now mac pap & petechia;
Racing heartbeat. Resting rate was between 87 and 100 bpm. No other symptoms occurred.
Uncontrollable itching from the knees down on both legs; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. Medical history included chronic pain, depression and gastroesophageal reflux disease (GERD), and known allergies with Latex. The patient's concomitant medications were not reported; the patient had multiple medications in two weeks. The patient had no other vaccines in four weeks. The patient has no COVID prior vaccination and was not tested for COVID post vaccination. On 25Jan2021 at 16:30, the patient had uncontrollable itching from the knees down on both legs. No treatment was administered for the event. The event had not resolved.   Information on the batch/lot number has been requested.
Patient reports feeling fatigue, chills, body aches, nausea,  and left arm soreness 12 hours after receiving 2nd Moderna vaccine.
I just kept having bowel movements and I already had one this morning, I mean it was just liquid/ diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the vaccine (COVID 19 vaccine by Pfizer) on the Thursday (04Feb2021), but Friday I had a bowel movement which is normal for me, but then yesterday (06Feb2021) I don't know what was wrong I just kept having bowel movements. And I already had one this morning, I mean it was just liquid. I don't know if it had anything to do with it or not. So I am trying to find out if that shot has been doing with the person having diarrhea?" Consumer confirmed the vaccine name as Pfizer COVID 19 vaccine and stated, "Yes, I had that shot on Thursday." Consumer stated, "What question, okay it's fine, I will just call them and find out. I just wanted to know if that or may be something I ate it, I got to figure out what it is." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
PT developed ST and fever 102.7, nausea and body aches yesterday; she got a second COVID vaccine, Pfizer, 2 days ago, she feels better today, able to eat and drink, but needs tests for work.
patient came in to ask Pharmacist on duty to look at her arm where she previously received Shingles vaccine. It appeared that the vaccine had been given SQ on the back side of the patients arm. the back side of the arm was bruised with redness and swelling. the Pharmacist on duty asked the patient what area of the arm She received the vaccine and she said on the back of her arm. Patient was advised to take acetaminophen and use heat or ice to relieve discomfort.
The patient has always been in extremely good health, and outwardly still appears the same.  The patient has been having complete blood work and carotid artery (CIMT) scans every six months for the past 5 years with the result that his arterial system intimately-media had the thickness of a person 20-30 years younger in terms to chronological age.  One month after the second Pfizer vaccination his arteries are now the thickness of a person on ly 10 years younger.  The vaccine may be resulting in endothelial inflammation.
Developed hives within 6 hours, then flu-like symptoms the following day. Developed nausea at around 36 hours which persists to present day. At day 5, developed sleep disturbances characterized by sudden nausea, racing heart, buzzing sensations, and involuntary eye movement. Lost 15+ pounds within the first 45 days. Seven plus months later, sleep episodes persist with diminished frequency a few times per week instead of nightly. Meal-related dyspepsia (including nausea, burning, fullness, bloating, distention, and belching) persists and occurs reliably after every meal. Symptom severity corresponds to meal size. Eating a single normal-sized meal produces severe symptoms within an hour and lasts for days. Placing weight on chest while horizontal exacerbates symptoms, even just resting a book there. Treatments that did not work: several courses of PPIs, SSRIs, elimination diets.
no adverse effect reported; second dose of GARDASIL 9 about a week ago after was administered first dose of GARDASIL 9 about a year ago; This spontaneous report was received from a pharmacist via company representative refers to a 19 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not reported.   Approximately on an unknown date in October 2018 (reported as "about a year ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), first dose (strength, dose, route of administration, lot/batch # and expiration date were not reported) for prophylaxis.   Approximately on 09-OCT-2019 (reported as "about a week ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), second dose (strength, dose, route of administration, lot/batch # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The patient experienced no adverse event. No product quality complaint (PQC) was reported.
Severe Pain in left arm beginning the night of the vaccine and continuing 2 days.  I could not move my arm. After 2 days I could move the arm slowly to pull a shirt over my head but still could not sleep on that arm. After 2 weeks the pain remains at a reduced severity .If I use the arm for lifting or sleep on it the pain intensifies.
On 11/5/99, the pt's lab results revealed a negative measles antibody titer and a positive rubella antibody titer. The pt's mumps antibody level was not tested.
Nausea, extreme headache, chills, fever, fatique (24 Hours) followed by cold symptoms (chest/head) (on going)
Chills/fever/extreme muscle, bone, joint aches/headache/nausea/tiredness
Diagnosed with possible Covid long haul on 6/15/2022 Tested positive for Covid on 8/2/2022- recovering at home.
severe pain in my right leg; could not walk; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in my right leg) and GAIT DISTURBANCE (could not walk) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MELOXICAM for an unknown indication.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in my right leg) and GAIT DISTURBANCE (could not walk). At the time of the report, PAIN IN EXTREMITY (severe pain in my right leg) and GAIT DISTURBANCE (could not walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided
got the shot on wed 3-17-21. Got flu like symptoms on Thursday and Friday the following days. On Saturday felt better but developed a rash all over my body. On my arms, back, neck, head, chest, legs, feet, waist. It started on Saturday the 3rd day after the vaccine and currently still have it. It calms down during the day and activates at night just before bed around 8pm.
Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid; Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 01Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "G6PD deficiency" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 31Dec2009, stop date: 19Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of Covid symptoms and positive rapid test four or five days after completion of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (unspecified date) Negative, notes: positive rapid test four or five days after completion of Paxlovid and negative test; (Jun2022) positive, notes: positive rapid test four or five days after completion of Paxlovid and negative test. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti-viral details was reported as Paxlovid with start date 9Jun2022,and stop date 14 Jun 2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hospitalization for failure to thrive, fall injury, COVID-positive, thrombocytopenia, Atrial fibrillation on dates 9/4/23-9/8/23.  Treated with no COVID-19 medications (asymptomatic).
positive Covid; positive Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2020 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Jun2020 at 09:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: I got Covid symptoms; (24Jun2022) Positive, notes: Got positive Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient did not receive any other medication in 2 weeks. After taking Paxlovid. The patient recovered from Covid. And one week later, she got Covid symptoms and got positive Covid again. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
INR went very high. 5.6 and Warfarin dose had to be suspended for two days. I also started to have blood in my urine.
Pt admitted for acute chest pain with NSR EKG and no ischemic changes.  Pt states that he had symptoms of COVID 2 weeks ago with headache, weakness, fever and chills without shortness of breath.
had shot and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Pt was feeling tired and had lost some weight. Her blood sugar and ketones were tested on September 17th 2021. Blood sugar was almost 500 and ketones were in the dangerous level (dark brown/black in rapid test). We took her to the emergency room where the tests were done again, verified and the diagnosis turned out to be Type 1 diabetes. She was treated in the hospital for four days and is now on an insulin regimen to control her glucose levels.
Pt devel fever & crying 11FEB92 cont Wed late Wed night early Thursday morning; Seen in ER t105.8;  14FEB91 pt still hot & fussy;
Extreme shoulder and arm pain after vaccination with limited movement of L arm for 3-4 days and slow improvement thereafter.
Patient reports onset of "ball in throat" sensation and metallic tasted in mouth after 1 minute of vaccine injection.  This was followed approximately one minute later with tongue numbness, tingling, swelling.  She did not report difficulty breathing and dismissed her symptoms as "anxiety".  She continues with sensory loss on the right side of her face with paresthesia around the right eye. She has seen her PCP for this condition at time of call.
N/a - none.  Expired vaccine was given (8 days expired) without an adverse reaction, or event, with the exception of the patient needing to be re-vaccinated.
The issues started about 15 minutes later with dizziness and nausea. My Dr. prescribed nausea medication in preparation for this dosage of the vaccine since the same thing occurred when I took the first dose.
Chills/ Fever/Body aches x 3 days.  Cervical lymphadenopathy x 1 week- extremely painful and swollen. Ice pack ATC and ibuprofen.
Received vac 8/5/03, developed rash, reported to employee health nurse 8/11/03, sent out to occupational health at hospital. Rash spread from shoulder to hand, treated for pain with acetaminophen hydrocodon. 8/15 rash and blisters complained of pain/aching in arm. 8/20 follow up Amitriplyline/pain meds, blisters often, weeping, has follow up 9/12. 8/28/03 blistered areas dry/red. No complaints at present.
many patients have reported flu like symptoms after getting the second dose of Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of  patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: Many patients have reported flu like symptoms after getting the second dose of Shingrix vaccine. No other details were provided. This case has been linked with US2020079554, reported by same reporter.
ulcerative colitis; lack of drug effect; joint pain; vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 18-Apr-2021.    This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included No adverse event (No medical history provided.).   On 16-Nov-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis) (seriousness criterion medically significant), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain). In March 2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. At the time of the report, COLITIS ULCERATIVE (ulcerative colitis), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact