chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
At 4 months and 6 months shots, mother states baby ran fever 103-104 into emergency room day after shot. Hx of vomiting and consolable crying.
This is nothing as serious as hospitalization or worse, but my son has never reacted to a single immunization in 4 years, and he has had a very very tough time with the Prevnar 13 vaccine. He complained for more than 24 hours about pain/soreness at the site of the shot. He did not sleep through the night as he almost always does. He had a low-grade fever for 24 hours (100.5.) He complained of a headache and he did not eat well. When I called the pediatrician, they said they have received a lot of feedback from parents about increased soreness at the site of the shot with this new vaccine. In talking to friends, I have also learned that other children had a hard time recovering from this vaccine. I don't know if these side effects are worth reporting or not, but since my son has never reacted this way to a vaccine, and has been so miserable for more than 24 hours, I felt I needed to report it for your recordkeeping.
Pt reporter high fevers, chills, delerium after 3 hours of receiving vaccination to point she couldn't leave  couch. Pt family member contacted physician stated fromHD flu shot.
pt recv vax 1JUL97 mom noticed Wed PM arm was red & sore;erythema 80mmx95mm;today arm sore to touch (lt deltoid);
PENTACEL dose was given, but not the complete dose. Only Dilunt was given, but it was not reconstituted making it incomplete.
Approximately 14 hours after immunization, patient woke up with nausea, vomiting, diarrhea, anorexia, and increased fatigue. Symptoms lasted for 7 days.
Janssen COVID-19 Vaccine EUA - almost exactly 6 hours after my vaccine I started feeling sick. All flu-luke symptoms- fever (102), chills, aches, nausea. The intense symptoms lasted for 12 hours and then eased up a little. Fever broke with acetaminophen and dropped to 99/100.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Within 20 minutes after the vaccine, I got heavy feeling in chest and that is a sign for me that my asthma is having issues. So I used two puffs of my albuterol inhaler. So then I talked to the nurse and told her I was having asthma symptoms. She wanted me to wait a little longer. I left about 40 minutes after the vaccine. I left to go home because I was feeling better. On the way home, I noticed my lips starting to swell and I didn't feel good. I took 10mg of Zyrtec when I got home and I took 40mg of Pepcid and then I felt a little better and I had to go to work and I'm a HCP. Later in the afternoon, my throat was itching. I called my primary care doctor and got an appt for Wednesday morning. I didn't feel good the rest of the day. I came home and was using my inhaler every four hours. I took 50mg of prednisone which is my rescue dose that they leave for me. I went to bed. My lips were still tingling and swelling. I got up the next morning, and I used my inhaler. I went to doctor and doctor said I was wheezing and I haven't wheezed in years. He prescribed me more prednisone and I went home and felt really horrible the rest of the day. My lips felt like they were swelling for the next 14 days. I was on a prednisone taper. I had to start using my Flovent inhaler. After that I had to use my nebulizer for a few days. I felt bad for 14 days plus. It really messed up my asthma bad. In February (about two weeks after the vaccine when I got my Adderall refilled I told my doctor that my heart was beating rapidly) I had a problem with my heart beating rapidly for two months after that. I had to go back to doctor and had two more doctor visits because of that. I had some pineapple about a month and a half ago and it made my lips swell up for three days afterwards and it flared my asthma which it has never done in the past. Usually (before vaccine) I could eat up to 5 or 6 pieces before it caused an allergy issue. This time it was about two pieces of pineapple and I got this reaction. I have never had that happen before. In April or May, I was having breast pain on the left side of my body. Last night it started hurting a little but by the end of May and beginning of June, I thought it was pretty much gone. The pain in the breast was painful to the touch and really tender and it was only on the left side of my body. It was really weird. A couple of weeks ago, I talked to co-workers and they said they had lumps in their breast too after the Moderna vaccine. I have an infection, an abscess in my navel area. I have never had one before. That started in April, I noticed it was swelling. I was watching it. May I went to the doctor for it. They cultured it and nothing came back but yet it was getting redder. And so I saw my primary care doctor, they gave me cephalexin for it. It's better but I need to go back and see him again and probably get more antibiotic. I have been using Bactroban ointment for it. Note: I refused to go to the ER because I'm a HCP. I saw that a week or two after I had the COVID vaccine, they recalled doses for adverse reactions.
Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day; Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day; my right arm where I received BOTH Covid-19 Doses STILL gives me pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 12:00 (Lot number: FF884) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Motrin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 03:15 PM), administration date: 13Oct2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (medically significant), HYPOAESTHESIA (medically significant) all with onset 04Nov2021, outcome "not recovered" and all described as "Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day"; PAIN IN EXTREMITY (medically significant) with onset 04Nov2021, outcome "unknown", described as "my right arm where I received BOTH Covid-19 Doses STILL gives me pain". The patient underwent the following laboratory tests and procedures: pain assessment (0-10): (04Nov2021) 6-9, notes: lasts anywhere from 5-10 minutes to half an hour at times. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia. Since his 2nd Covid-19 vaccine dose, that he had took on my right arm he had been experiencing tingling and numbing as well as a pins and needles sensation feeling coming from his bicep, tricep, arm, hands and into my fingers in waves throughout the day. The waves come and go throughout the day at least 8 times a day so far. The pain level, when it comes, ranges from a 6-9 out of 10 and lasts anywhere from 5-10 minutes to half an hour at times. He purposely slept on his left arm to reduce the pain, but his right arm where he received both Covid-19 doses STILL gives he pain. He woke up and go to sleep with the numbness and pins and needles sensation. It feels as if her arm was "asleep" but also aches and felt very sore. There was no Covid tested post vaccination.
Red face; Tingly tongue and lips; I did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose). At the time of the report, ERYTHEMA (Red face) and PARAESTHESIA ORAL (Tingly tongue and lips) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment drugs were not reported by the reporter.
after administration of vaccine, pt was waiting out her 15 minutes in a chair in our waiting area. Pt started experiencing a vasovagal response to the vaccine where she lost consciousness and started to twitch for around a minute. Two pharmacists responded and immediately supported her upper body and raised her legs to get blood flow back to her head. The patient came to where she was given water and we monitored her for an additional 30 minutes until her partner came to pick her up.
No other AE occurred; Patient received a dose of VAQTA after it was stored outside of the recommended storage range.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication, drug allergies and reactions were not reported.   07-JUN-2021, the patient was vaccinated with an improperly storage dose of hepatitis a vaccine, inactivated (VAQTA) lot # T035721, expiration date was reported as 15-APR-2022 (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature of 51 °F for 1 hours. No previous temperature excursion was reported. No adverse effect was reported. The report was received due to a data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Information has been received from a mother concerning her son who was vaccinated with a dose of varicella virus vaccine live, when he was supposed to be. It was reported that fatigue and an off and on low grade fever started on 02Feb06. One itchy spot was noted on 04Feb06. 3-4 spots were noted on 06Feb06. The pt's mother spoke with a physician on 06Feb06 who diagnosed chickenpox. The physician told the pt's mother to use diphenhydramine hydrochloride (Benadryl) cream and/or oral diphenhydramine hydrochloride (Benadryl) for itchiness and acetaminophen (Tylenol) and ibuprofen (Advil) for aches and/or fever. The symptoms were ongoing at the time of the report. Additional information has been requested.
This case was reported by a consumer and described the occurrence of asthma-like symptoms in a 6 week old subject of unspecified gender who was vaccinated with hepatitis B vaccine for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. Concurrent medical conditions included fever at birth and neonatal jaundice. On an unspecified date before 7/12/05, the subject received a dose of hepatitis B vaccine (dose number not provided). On an unspecified date on or before 7/12/05, the subject experienced respiratory problems manifested by asthma-like symptoms, shortness of breath, and wheeziness. The outcome of the events was not reported. Comment: Asthma-like symptoms was assessed as medically serious (OMIC).
17 year old male patient received expired dose of Menactra with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 23-Mar-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U654343AA and expiry date: 23-Feb-2021) (Frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that the description: Office manager states that staff gave expired dose within a month of expiration date and asks if there is potential harm, how potent the vaccine is, and should another injection be given.  Reporter relationship: health care professional (HCP) Product used: used Still using product: no   At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient is a 58y.o. male with PMHx of Alcoholic cirrhosis of liver with ascites, liver transplant candidate, NASH, ?new CKD requiring HD, esophageal varices, HTN, HLD,  COPD, DMII and HFpEF who presents to the ED with c/o dizziness. Patient states he was so dizzy he couldn't see anyone. States he has recently been admitted to facility, however states that whenever he gets discharged from there he has to go right back in, prompting him to present to Hospital. Patient states that this morning he began experiencing dizziness - states he was unable to walk or see. Upon arrival patients blood sugar was 46. Patient states he felt better after receiving dextrose. Patient states he has been admitted for acute on chronic heart failure and AKI requiring HD. States he was receiving HD Tuesday, Thursday and Saturday while hospitalized, and was due to attend his first outpatient session tomorrow. Patient states he is also on the liver transplant list. Denies any fever, chills, dizziness, lightheadedness, vision changes, chest pain, palpitations, shortness of breath, abdominal pain, nausea, vomiting, diarrhea or constipation. Denies any tobacco, EtOH, marijuana or illicit drug use.   Seen by me this am. Wants to be available to his family for his Dad's funeral scheduled for noon today. Made aware of need for isolation and people avoidance d/t pos Covid status. Asymptomatic. Feeling at baseline this am.  Cleared for dc by nephro and cardio. Discussed this am. Patient denies CP/SOB. No Dyspnea w activity. No new Gi or Gu complaints.  No fever/chills.   Will allow for dc before noon, though he is advised to ISOLATE/ covid. Aware of his personal risk  w Covid.  Aware he could be a candidate for Monoclon abs this am. He insists dc today.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Night after 1st shot, patient had some chest pain/pressure on/off that lasted for 3 days. Very mild & no difficulty breathing. Patient had COVID in February & had chest tightness/pressure during that infection. Patient didn't require any treatment & recovered on her own.
Arm pain, body aches, headache, fever, chills, night sweats, fatigue.
AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL). In 2021, IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL) had resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of after first and booster vaccine did not feel well with skyrizi(risankizumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623129 (Patient Link).
It was reported that a pt (1 of 2) received a Tripedia vaccination. Reportedly, sometime after the vaccination, the pt developed a large local reaction. No specifics were provided. From additional correspondence Received on 12/6/00, it was reported that the pt's local reaction consisted of a large hot area, the size of a small chicken egg. Reportedly, the pt recovered from this experience.
Localized reaction to DTaP. Red, warm to touch no cellulitis. Tylenol or Motrin, Benadryl.
Nine hours after the injection, I had a fever with some chills. I don't have a thermometer, so I couldn't take my temp. I also developed a strong headache, muscle aches some joint pain, and a brief instance of nausea.  All but the headache faded significantly by late afternoon of the next day.
local site reaction with redness, swelling, induration, rash - started 12 d post vaccine, Mild