chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. 2 years after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Non stop crying: 4 hours; low grade fever; loss of appetite; vomiting-----Tylenol infant.
COVID+ 10/15/22 - Vaccination status - pfizer x4   BRIEF OVERVIEW: Discharge Provider: DO  Primary Care Provider at Discharge: MD Discharge disposition: MFB Condition on discharge: Stable.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute kidney injury (HCC) [N17.9] COVID-19 virus infection [U07.1] Generalized weakness [R53.1]   HOSPITAL COURSE: Is a 74-year-old gentleman with a history of AFib on Xarelto, BPH with chronic Foley catheter, insulin-dependent type 2 diabetes, hypertension, sleep apnea, iron deficiency, and bolus pemphigoid on chronic immunosuppression.  He presented to the ER due to generalized weakness and recent fall at home.  Patient had viral symptoms beginning on 10/08.  He had recently started Bactrim, per his urologist, for possible urinary tract infection in setting of new hematuria.  Initial workup in the ER revealed AKI on CKD 4, hyponatremia, and tested positive for COVID-19 on 10/15.  He was admitted to Internal Medicine for workup and therapy evaluation.   Regarding COVID-19 infection, chest x-ray was negative for infiltrates, so patient was treated with supportive care.  He did not require supplemental oxygen.  AKI and acute hypovolemic hyponatremia resolved with IV hydration.  Urinalysis was negative for infection and patient was without hematuria so no further antibiotics were given.  PT/OT evaluated the patient and recommended SAR.  Care manager assisted with placement and patient discharged in stable condition to MFB.   While inpatient he had renal US showing possible renal cysts. Instructed to follow up with PCP for repeat US in 6 months to ensure stability
I noticed a hive forming 4 weeks after second vaccine. it started small and grew almost to the size of my upper arm within a few days (left arm). I also grew an identical hive on the right arm where I had received my first vaccine. They are hot, itchy, swollen (one day), red, painful and sting like fire or glass. Took Benadryl, Claritin, cold hydrocortisone cream and ice packs for the first few days. Got an appointment with my doctor and was prescribed three days (2 pills at 40mg) of Prednisone (steroid) and was told to take 20 mg of Pepcid to tackle the itch and inflammation. I was also told to continue what I was already doing. I still have the hives and it is currently five days after initial sighting. They are also different than my first hives. My first hives were spots around my right elbow. These hives are small spots around the injection site with large areas of redness surrounding them.
Eight days after getting the 1st dose of vaccine I felt a burning sensation at the shot site. Then I noticed I was itching  it. At that time I realized the area had 2 hard "bumps" when I scratched it.  When I looked in the mirror, the shot site was a blotchy-red color and there were 2 "lumps" (or bumps) there that felt very hard.   The next morning (today, 02/26/2021) it is still there, but not as bad.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (also reported as sterile diluent/vaccine) lot # M005714, expiration date 03-OCT-2017, intramuscularly (dose and anatomical location were not reported) after the vaccines went through a temperature excursion (of going up to 49.4 degrees Fahrenheit for 40 minutes), which was other than indicated in the Prescribing Information. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Severe pain in arm, cough, fever, headache, congestion, etc Flu symptoms.
Swelling in the right side of her face after 2nd booster; Pain traveling down her throat after 2nd booster; Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939904, 038A21A and 014M20A) for COVID-19 vaccination.     Patient was totally healthy. She never had COVID disease and never had a positive PCR.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster). At the time of the report, SWELLING FACE (Swelling in the right side of her face after 2nd booster), OROPHARYNGEAL PAIN (Pain traveling down her throat after 2nd booster) and LYMPHADENOPATHY (Swollen Lymph-node under the right side of her chin (Between Chin and Ear) after 2nd booster) outcome was unknown.            Patient did not take  concomitant medications. Reporter stated that his wife did not inform the doctor and she had not taken any medication to relieve the swelling and pain.
Within two minutes of injection: started feeling flushed, light headed, elevated pulse, and tightening of my throat. Waited 30 minutes at site while physician monitored my symptoms. Flushness, pulse rate and feeling of throat tightness diminished over the 30 minute period and I was released to leave. On the way home I bought Benadryl and took 50 mg. I began to feel more normal 1-2 hours post injection.
I noticed sometime in May; the bottoms of my feet feel numb. I had a broken toe in my left foot that had some leftover numbness. I realized that both my feet felt numb, my left side more. In my pads, toes and heels of my feet, I have numbness. The doctor did test feeling via poking my feet and I did feel that. The doctor did a test with a sound bar where she put it on my wrist and I felt it but when placed on my ankle, I did not feel anything. I also have no muscle weakness to accompany the numbness which is usually common. I don?t feel sick at all. It?s just that all of a sudden, my feet are numb with no explanation.  There were blood tests done regarding vitamin deficiency, thyroid, Lyme disease, wheat allergy. I have never smoked, drank. I am not a diabetic or anything like that. I am waiting to get a nerve test in October.
Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate.  pharmacist gave 1 dose of IM EPI in the L thigh
Numbness to right side of face, Hives/bloches red to face & chest. Heaviness to chest, shortness of breath, dizziness, headaches.
fever up to 104.4, difficult to control w/APAP; vomiting 23JUN 4AM; congested sounds in lungs; went to ER; lt leg has small area of bruising; whiney; sleeping 2-3x, irritable; dec appetite;
COVID INFECTION AFTER VACCINATION(DELTA VARIANT); SLIGHT SCARRING UNDER ARMS AND CHEST; STINGING BURNING RASH OF ABOUT 1000 BUMPS LIKE A BABY'S HEAT RASH ON THE FRONT OF CHEST AND UNDER ARMS; ITCHING RASHES OF ABOUT 1000 BUMPS AND BIGGER HIVES ON BACK SHOULDERS AND BACK; This spontaneous report received from a patient via a company representative concerned an adult female. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid infection after vaccination (delta variant), slight scarring under arms and chest, stinging burning rash of about 1000 bumps like a baby's heat rash on the front of chest and under arms, and itching rashes of about 1000 bumps and bigger hives on back shoulders and back. Treatment medications (dates unspecified) included: calamine, and diphenhydramine citrate/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging burning rash of about 1000 bumps like a baby's heat rash on the front of chest and under arms, and itching rashes of about 1000 bumps and bigger hives on back shoulders and back, and the outcome of covid infection after vaccination(delta variant) and slight scarring under arms and chest was not reported. This report was non-serious.
Pt experienced fever of 101 and dizziness next day after shot given. Pt took Advil to lower temp.
Described persistent shoulder pain with some weakness. Pain to UE was still present on 1/09/2015 when pt. came in for annual PE. Stated ibuprofen gave mild relief of pain sx.
I have noticed tinnitus in both ears, a constant high pitch ringing that is non stop and only exacerbated at night. Just a few days after my booster, this side effect began to keep me up at night. I fear hearing loss as a side effect of Covid-19 or its vaccines
Sever body aches lasting a day followed by severe  stiff neck starting on the left side and then moving to the right.  Stiff neck still there on 3rd day.
Patient was administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM (SINGULAIR), NAPROXEN and OMEPRAZOLE for an unknown indication.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. The patient was not known to be experiencing any side effects or symptoms at this time.
Herpes Simplex virus of the eye. Very painful and still not cleared. Began on day 6 after second vaccine. Had this 16 years ago and never again so I assume it is the vaccine or process that reactivated the virus in my eye. Also had lameness for a day, sore arm for 3 days vs the soreness I had for only 8 hrs after the first shot, lower legs burned for about a day
Began to have severe cramps, vaginal discharge, feeling in well, which led to passing of big blood clots and bleeding...my baby no longer had a heartbeat...I was 8 weeks and 1 day pregnant...
Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Imaging procedure: Unknown Results; Magnetic resonance imaging: Unknown Results; Ultrasound scan: Normal in reported cases.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201126704 Same article/ drug/event and different patient.;US-PFIZER INC-202201126706 Same article/ drug/event and different patient;US-PFIZER INC-202201126705 Same article/ drug/event and different patient;US-PFIZER INC-202201126707 Same article/ drug/event and different patient;US-PFIZER INC-202201126708 Same article/ drug/event and different patient;US-PFIZER INC-202201126709 Same article/ drug/event and different patient;US-PFIZER INC-202201126710 Same article/ drug/event and different patient;US-PFIZER INC-202201126711 Same article/ drug/event and different patient;US-PFIZER INC-202201126706 Same article/ drug/event and different patient.;US-PFIZER INC-202201126704 Same article/ drug/event and different patient.;US-PFIZER INC-202201126710 Same article/ drug/event and different patient;US-PFIZER INC-202201126711 Same article/ drug/event and different patient;US-PFIZER INC-202201126705 Same article/ drug/event and different patient.;
Within 13 days of the last booster, He was diagnosed with Type 1 Diabetes. No previous symptoms had been observed.
Despite suspension of Humira, IgG Covid-SARS antibody test on 25May2021 result < 1; Despite suspension of Humira, IgG Covid-SARS antibody test on 25May2021 result < 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) received via COVID-19 reporting system. The reporter is the patient.   A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 11:00 (Lot number: EL9267) at the age of 70 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), from 04Jan2021 (Batch/Lot number: unknown) to 2021. Relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Allergies to codeine" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN; PANTOPRAZOLE; LETROZOLE; SOTALOL. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3249, Administration time: 11:00 AM, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 20Jan2021, when the patient was 70 years old, for COVID-19 immunisation. The following information was reported: VACCINE INDUCED ANTIBODY ABSENT (non-serious), DRUG INTERACTION (non-serious) all with onset May2021, outcome "not recovered" and all described as "Despite suspension of Humira, IgG Covid-SARS antibody test on 25May2021 result < 1". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for adalimumab was temporarily withdrawn on 2021. Therapeutic measures were not taken as a result of vaccine induced antibody absent, drug interaction.  Additional information: IgG Covid-SARS antibody test on 25May2021 result < 1. Patient was on Humira prior to vaccine. Last Humira shot prior to vaccine was on 04Jan2021. Humira was suspended during vaccine period and Humira resumed on 22Feb2021. Apparently vaccine did not provide immunity, despite suspension of Humira during vaccination period. The patient did not take other vaccine in four weeks, did not had COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Mild throat swelling, flushed, slight shortness of breath, symptoms subsided after evaluation
Patient received the Tdap on 1/2/13 and developed an itchy rash all over her body, which improved with BENADRYL short term but persisted. Patient saw a doctor on 1/4/13 and was prescribed methylprednisone and an anti-itch cream.
Started feeling fatigue at work, when got home noticed that arm was red and swollen, was hot to touch.  Not where shot was but below near bicep. Was dizzy and felt "very strange", Got fever of 101 degrees, got chills.  Daughter's pediatrician noticed the swelling and prescribed antibiotic.
Shingrix shot #1 / on 02-Sep-2019. More than 6 months has passed / not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose on 2nd September 2019 batch number 9LG54 and expiry date 25th September 2021, intramuscularly at the retail pharmacy).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. More than 6 months had passed and the patient had not received second dose which led to incomplete course of vaccination. The reporter wanted to know could 2nd dose be given now or does the series needs to be re-started. The reporter informed vaccine administration location same as reporter. The fax number of pharmacy was provided by patient but did not have work email account. No further details was provided. Consented to follow up was unknown.
Patient admitted with palpitations (racing and pounding heart in his chest) with some episodes of nausea and vomiting  and low grade fever 4 days after receiving first dose of the covid 19 vaccine. No chest pain ever reported by patient. These symptoms began a few hours after patient completed a weight lifting workout with caffeine ingestion (approx 300mg) prior to workout and after a night of binge drinking. Patient believed to have suspected myopericarditis given lack of coronary related explanation for elevated cardiac enzymes despite a normal cardiac MRI for myocarditis (believed may have been completed too soon in course). Viral testing negative for potential cause of myocarditis. Patient's heart rate treated with metoprolol resulting in resolution of palpitations. Patient was also treated with colchicine with decrease in inflammatory markers.
Abnormally high blood pressure (I've always had LOW blood pressure), tachycardia, and thousands of PVCs (Premature Ventricular Contractions) per day, fatigue, chest pain and pressure.  Two emergency room visits, multiple cardiac tests. Three different heart/bp meds tried.  None of them control ALL the symptoms, only some.
After approximately nine (9) days a rash appeared at the injection site that became the size of a silver dollar.  On day 13 the rash appears to be going away on its own after turning into a bruise, then light brown on day 25.
Note 01/18/2021 Wife called patient has been ill all weekend.  He is pale, passing out, Arhythmia, no fever, no cough, no SOB (but hasn't been doing much either).  Was going to have pt seen this am, but spoke with healthcare and wants Pt to go to ER for emergent testing. Called wife back and she was notified.  CHEST PAIN, PALPITATIONS, NAUSEA, SOB
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site swelling and pain in arm. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site swelling and pain in arm to be related to BEXSERO. Additional information was received as follows: The age at vaccination was not applicable for this report. The demographic details of the patients was not reported. The physician stated that generally she had several patients who had experienced a sore arm / pain and swelling at the injection site for several days. She also said that in her experience the incidence appeared to be greater than other adolescent vaccines (i.e., HPV, MCV4).
Temperature of 99.6-99.7 F which is high for the patient.; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 625ALIA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills). At the time of the report, PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.6-99.7 (High) Temperature of 99.6-99.7 F which is high for the patient..         Treatment information was not provided.