chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experience severe reactions; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
dangerous and painful symptoms; Headaches; ears ringing; uncontrollable shivers; back pain; joint pain; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach. On an unknown date, the outcome of the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, ringing in ears, shivers, back pain, joint pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient get vaccine and it was the most painful injection followed by all the side affects . The reporter telling everyone about the dangerous side affects. The patient experienced  headache, ears ringing, uncontrollable shivers, back pain, joint pain, upset stomach going on two days. The patient could not get the second shot and should not have to pay and the insurance should not be charged.
Pt.'s mother states that after receiving the 1st dose of the Phizer 06/29/2021, started experiencing symptoms 06/30/2021 of elevated pulse rate, chills, tiredness, fatigue, and eye lid swelling still continuing. Lymphoids swollen, sore throat, headaches, and still continuing. Primary visit -8/05/2021 diagnosed with EBV, recommendation for rest.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycilin, reaction(s): "Known allergies: amoxycilin", notes: Known allergies: amoxycilin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT recvd vax on 18AUG92 & 5 days later noticed an ecchymotic lesion measuring 1 inch by 3/4 inch on rt forearm; It was non-tender & had a brownish center w/blueish periphery;
Warm, tender lump on Rt. Deltoid 11x14 cm, bruise
Ran a temperature of 100.0 one day post vaccination. No signs or symptoms and no fever since.
ACUTE NON ST ELEVATION MI 11/20/2021 -- RECURRENCE OF SAME SYMPTOMS
Subject had received Hep A, Tdap and Vivotif (typhoid) vaccination from another health care provider on 7/14/2008. On 7/28/2008, subject was given MMR vaccine to left arm, YF Vax Vaccine to right arm subcutaneously.  On 7/30/2008 subject was observed to have edema to right axillae which she reports began the morning of 7/29/2008. C/o tenderness to swelling site.  Denies fever, throat itching, other swelling or other symptoms. No redness observed to axillae or area.   Subject reports no previous history of receiving YF Vax, no allergies to eggs, no history of thymus disorder or other immune compromising condition. Subject describes herself as in good health.
Noise started in right ear 2 hrs after receiving vaccine,  1 day later ear is completely clogged,  can't hear anything but ringing in right ear, went to Dr, gave me 5 prescription,  nothing working
Patient presented with her family to Urgent Care for a Covid vaccine. Urgent Care was administering Janssen vaccines only. Urgent Care staff made the Covid Vaccine Clinic known that the patient was presenting for a Covid Vaccine. Urgent Care was then informed that a Janssen vacine was not to be given to the patient because she only 12, and Pfizer is the only vaccine she is allowed to recieve. Urgent Care staff then went to the Pediatric department and retrieved a Pfizer Child syringe, took it back to Urgent Care, and administered it to the patient. Urgent Care staff then contacted the Covid Clinic to provide information so proper tracking and documention can be completed. Upon receiving the information, Urgent Care was then made aware that the patient was 12 and should have received an Adult Pfizer dose, not a Child Pfizer dose.
As a 1a health provider I received my vaccination a weekend half ago resulting in dizziness, difficult mentation eg, administering my clinic, headache, a firey, red, rash over 90% of my upper body and 30% of my lower body, joint pain and muscle ache, worsening  So far all the medical help I have received advices cortisone for the itch but I am really  trying to understand what I need for my immune system and should I, or should I not get the 2nd dose
small red bumps upper torso, both arms, chest and legs, waste and knees. some on one of my feet. it is pretty much all over my body.  they were shiny but seem to be drying up now.  the tone on the red is not as bright as it was. called Dr and was told not to take the 2nd dose
Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4); This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes infection, at a dose of 500 milligram. At the time of the report, HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       List of concomitant medication were not given.
After vaccination, patient was sitting in a chair and got up to say she was feeling lightheaded then fainted. Patient regained consciousness within seconds. Patient was helped up in a seated position in a chair and was instructed to take deep breaths and keep head between knees. Patient was also given water and fruit snacks. An ice pack was also placed on the back of patient's neck because patient complained she was feeling hot. Patient was able to communicate and remember details. Patient did not complain of any pain anywhere on the body. Pharmacy technician was at the patient's side the entire time after she regained consciousness. Patient was able to call her mother to pick her up and drive her home.
Pain in triceps; Redness in triceps; Swelling in triceps; A spontaneous report was received from healthcare professional concerning a 66-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain, redness, and swelling in triceps.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly in the right arm triceps for prophylaxis of COVID-19 infection.  The patient reported that the nurse put it in the triceps instead of deltoid. On 04 Feb 2021, the patient experienced pain, redness, and swelling in triceps. Treatment information was not provided  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, pain, redness, and swelling in triceps, were ongoing.; Reporter's Comments: 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.
Pt was mistakenly given TDAP when was supposed to receive DTAP.  (Medication Error).
Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334 and expiration date 05-OCT-2017, (strength, dose and anatomical location were not provided) subcutaneous. No adverse effects were reported. Data logger was involved. It was reported that there were no previous excursions. The temperature of the reported excursion was 24 Celsius (C) for a time frame of 72 hours. This is one of several reports received from the same source. Additional information has been requested.
Redness amd itching below site of administration. Itching of both arms chest and neck. "head felt foggy".  felt like she was breathing fast.
The first shot threw her out of remission and into an IBD (Crohns) flare with liquid stool about one week after the shot and visible blood in her stool for a week. The second shot caused a fever of 102.5 for about 12 hours and tiredness the next day as well as throwing her into a worse flare where she had liquid stools at least 4 days with visible blood two days after the vaccination. We are still dealing with the flare, so I do not know how long it will last or if she will need steroids to get her back into remission.
soreness under my arm and below the arm pit; my breast got sorer; a lump that was sore and angry; low Vitamin B12; diagnosed a left knob on my left breast and then my right breast probably the same thing; uncomfortable; I had a breast issue with the Pfizer vaccine, with my lymph glands, I had the biopsy and then the other one my other breast is; it is not as severe as 1st one but my other breast I can feel that issue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9269 and expiration date were not reported), via an unspecified route of administration on 10Feb2021 (Age at vaccination was 84 years) as dose 2, single for covid-19 immunization. Medical history included , hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported; vitamin b12 nos taken for an unspecified indication, start and stop date were not reported; vitamin d nos taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9261 and expiration date was not reported), via an unspecified route of administration, on 20Jan2021 as dose 1, single for COVID-19 immunization. On unspecified date in Apr 2021 patient reported that she had breast problems and she attribute it to that and she think her doctors do as well. Patient didn't have the reaction until Apr in her breast, she noticed soreness in under her arm down below her armpit and then in the breast itself soreness for a while and then all of sudden got really sore, patient put that on maybe she slept wrong, or exercised wrong or did something and she had visited Doctor and her Internal medicine Doctor, she sent her to have a monogram, sonogram and they started to do about, they did a biopsy. She was cancer free of course but in her other right breast she felt the same feeling in her right breast, in lower part of her breast right side at 7 o'clock. Patient was wondering and want to know how long this will go on, Do we have any knowledge on what to do, because of the vaccine. Now she had a question in her mind that it was because of reaction to that vaccine and they diagnosed a left knob on her left breast and then her right breast probably the same thing. Her question to Pfizer was how many people are experiencing this. The patient underwent lab tests and procedures which included biopsy with result on it is not as severe as 1st one but her other breast she can feel that issue. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are needed. No further information is expected.
Client with left arm soreness and swelling the night of injection, woke with enlarged lymph node in left side of neck and axillae, with nodule noted left clavicle area.  Client to follow up with her PCP.
Pain with injection, pain in Left Elbow since 3rd Anthrax injection.  Treated with Motrin 800mg tid.
Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable other healthcare professional (hcp; patient for herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, HTN (hypertension), migraines, and blepharitis. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), metoprolol tartrate, lisinopril, colecalciferol (VIT D3), fish oil, and "mul" as reported. The first dose of BNT162B2 (brand Pfizer, lot EL1284) for COVID-19 immunization was administered on 22Dec2020 at 05:30 pm in the left arm. The patient had no other vaccines in four weeks. On 13Jan2021 08:45 pm, the patient experienced fever, joint pain left side, rash on legs and headache. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events fever, joint pain left side, rash on legs and headache were recovered on an unknown date in Jan2021.
sinus infection; mucus; tired; back rash; lost sense of taste; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus infection, increased viscousity of upper respiratory secretions, fatigue, rash and aguesia.       The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, sinus infection, mucus, tired, back rash, lost sense of taste.  Treatment details included azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, sinus infection, mucus,tired,back rash,lost sense of taste was unknown.
Herpes zoster developed 3 days after receiving the vaccine. I am reporting this as I saw two other patients who had symptoms of neuropathic pain in a nerve root distribution several days after receiving flu vaccine. All received their vaccines at other locations as I can't give specifics on vaccines.
Pt. seen in clinic on 8/13/15 with scattered vesicles and one bulla at injection site. She received zoster vaccine at her primary care doctor's office on 8/11/15.
Diffuse rash beginning on cheeks then over abdomen and back. Mild fever (101-102.6).
Pt experienced a morbilliform rash even involving the palms of hands. Pt experienced a fever at onset.
Patient stated she received second vaccine on 3/25/21 and right arm still hurts when she uses it. RN asked if she told her provider and she stated she has not RN stated to call provider and let him know that after two months arm still hurts. She stated understanding.
tingling in the arm at site of injection; slight bruising an pain at injection site.; slight bruising an pain at injection site.; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number: unknown), in the arm, as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in the arm at site of injection"; PANIC ATTACK (non-serious), outcome "recovered", described as "panic attack"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious), outcome "unknown" and all described as "slight bruising and pain at injection site.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, vomiting and diarrhea.   Clear liquid diet.  Rest.  No work for two days.   When lab returned normal,  Lomotil taken for the diarrhea on 12/29/2020.
8 days p/vax pt noted area very white & sunken leading to muscle atrophy of the area;
Headache,severe,developed backache within 12hr of vaccine,fever,myalgia,no evidence of muscle weakness, treatment with 800mg ibuprofen q6-8hr,pt seen within 24hrs after vaccines given
Tightness in chest and throat 4-5 hours following injections. In ER; nebulizer tmt given and cortisone. Rx for Prednisone 20 mg 2 QD x 3 days.
having gotten shingles even though she had previously taken Shingrix/ suspected vaccination failure; shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: having gotten shingles even though she had previously taken Shingrix/ 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 Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2023 The patient took Shingrix shot to prevent shingles in the past and recently got shingles anyway.  This doctor was not her doctor at the time she got the Shingrix shot but he did comment the patient did report having gotten shingles even though she had previously taken Shingrix. The physician requested not to contact him/her.  He was her recent doctor and did not know the exact details of when she had Shingrix or how long of a time had elapsed before she got shingles. 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.
pt seen 26MAY92 routine exam; pt recvd vax 7JUL92 & exp seizures 9JUL92; poss neurological dysfunction, post-ictal period;
Originally admitted for septic shock and liver failure, found to have COVID pna several days in. Fully vaccinated 4/2021. Required mechanical ventilation. Steroids, rocephin, vanc, vit-c, vit-d, cefepime, zinc. Not a candidate for remdesivir due to liver failure. Transitioned to comfort measures and expired.
New onset  generalized seizure, arrhythmia. Patient was sent to ED where labs and imaging were normal. She is now back at baseline and will be seeing a neurologist.
The patient was age 3 days, received a Hepatitis B vaccine, UNKNOWN LOT, UNKNOWN MAKE since it was in the hospital and less than 5 hours later he developed hives on both legs, lower back and his groin lasting about 4 days.
Fever, chills, fatigue, nausea, diarrhea, itching all over (itching has resolved).  All but chills and fatigue have resolved.
4 days after receiving vaccines child developed an intermittent fever and irritability that lasted for 2 to 3 days. Child also developed a rash on abdomen that spread to shoulders and this lasted for 3 weeks. Rash caused discomfort. Decreased appetite for 3-4 days.
Child experienced a seizure after administration of vaccines.  Occurred approximately 10 minutes after the administration of MMR, VZV.
Allergic reaction around injection site. Patient told to take Benadryl 25mg QID, cold compresses.
Approximately 3 days after the booster shot I started having sharp pain in the lower right quadrant of my abdomen and uncontrollable, explosive diarrhea in addition to night sweats and physical exhaustion.  I had the exact same symptoms after my first dose of Moderna vaccine on April 17, 2021 and receiving my second Moderna vaccine shot on Sunday May 16, 2021.  I ended up in the emergency room for a suspected appendicitis on May 29, 2021 after continued pain spasms and inability to retain food and an Urgent Care doctor urging me to go to the ER immediately with a suspected appendicitis.  The CT scan at the ER revealed instead that I had an inflamed ileocecal valve.  The gastroenterologist I went to after that diagnosis assured my wife and I that this was not from the vaccine,  but after experiencing the same bodily response for the third time, I have no doubt that this is a direct reaction from the vaccine.  I am unsure what version of the influenza vaccine I received on January 12, 2022 and only retained my Moderna booster paperwork.