chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous consumer report (initial receipt 21-AUG-2014) concerns a 54-year-old female patient. The patient had a medical history of asthma, high blood pressure and diabetes. The patient received flu vaccines every year and tolerated it in the past.  On 08 JAN 2013, five minutes after vaccination, the patient's hands began to feel icy cold as if the fingers would fall off. She wore gloves and returned to the clinic, 10 minutes later. Her vitals were evaluated, which were normal. After leaving the clinic, she noticed that her hands , arms, stomach and chest were painful and would burn. She had burned marks on these areas that resembled chemotherapy burns from cancer treatment.  The patient confirmed that she never had cancer. These burned areas of the skin occasionally will tighten-up causing additional pain. There were some marks on her face as well. These burned areas of her skin had not changed since she received AFLURIA. She was sent to a dermatologist for evaluation. She received a cream to use only when the tightening sensation occurred on the skin. The burned areas were dry and she had to use a Vaseline to assist with dryness.  The outcome was reported as recovered with sequelae for the event of icy cold hands, however, the other events had not recovered.
After 3-5 minutes after injection felt anxious, shaky, lightheaded and stated he "felt off". Patient in chair and notified observation staff who notified POD manager RN. Patient stated he had not eaten today, given water, peanut free snack and room temperature made cooler. At 1535, patient states all symptoms are resolved.
This spontaneous report was received from a pharmacist who was informed by the patient's husband, a currently 56 year old female patient. Concurrent conditions or pertinent medical history were not reported. On 13-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (lot # K020802, expiration date 31-JAN-2016) 0.65 ml, for the prevention of herpes zoster. Concomitant medications were not reported. On an unknown date in 2015 after receiving the vaccine, the patient experienced an unspecified reaction (adverse event following immunization), and it was started that at the time of the report, the patient still had 'discoloration" that looked like a bruise at the injection site. It was stated that the patient did not sought for medical attention, that no intervention to prevent serious criteria was necessary, that the patient did not die or was hospitalized, that there was not any significant disability or incapacity and that the events were not life threatening. At the time of the report, the outcome of the adverse event following immunization and administration site bruise was unknown. The relatedness of adverse event following immunization and administration site bruise with ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Extreme chest pain that subsided after five minutes.  Very winded during even a  short walk for a month after the event. Still having random palpitations over a year later.
Urinary tract infection symptoms. Feeling of urination urgency, burning sensation, testicular inflammation. Diagnosed as acute right epididymitis by urgent care clinic. Treated with a single shot of Ceftriaxone plus 7 day treatment of Doxycycline 100mg twice per day. Still under treatment, symptoms improving but still present.
Worsened swelling in toes and fingers and hand pain, felt to be pesudogout.
Client was in the office for catch up vaccinations. This nurse miscalculated the client's age to be 6 months old, when in fact she is 5 months old. The needed vaccinations were determined to be PEDIARIX, Hib, PCV13, and Flu. This nurse discussed these vaccines with patient's parents before being prepared. RN assisted this nurse with administration of the Flu and Hib vaccines for the comfort of the client. The Flu vaccine is made by Sanofi, Lot UT4118CA, dose 0.25cc, given IM to the right thigh on 9/19/11 at 1340. The clients were advised to wait in the lobby for the 15 minute waiting period, during which time, no adverse effects were observed or reported by patient's parents. The next day as the immunization secretary was verifying the vaccine information inputted into the system, she noticed the miscalculation of the client's age and reported it to this nurse. This nurse then reported the error to the Region Supervisor. This nurse attempted to contact patient's parents via several phone numbers from the Administration Record, the chart, and information from her listed primary provider's office. All the numbers were disconnected or were message numbers that did not respond. A contact letter was sent to the address listed on the Administration Record requesting patient's parents call me at the office when they received the letter. The primary provider listed in the chart is Dr. of Pediatrics office. Her office was notified by this nurse who spoke with Dr.'s nurse. Nurse reports the Dr. is listed as the client's primary provider, but they have not seen her as of yet. Dr. did advise to repeat the dose and then do the booster dose a month after the repeated dose when the child is 6 months of age. This nurse will verify how the client has been followed with for well-child check ups and will have the parents notify Dr.'s office with the same information. This nurse will write out all the calculations of age in future to avoid any further miscalculations.
I have an elbow (left arm which vaccine was given) with fluid in it and am not sure what to do about it.  I have never had this before I got the Covid Vaccine.
14FEB92 5AM temp inc continued thru 16FEB92; rash appeared same time on face to feet; 21FEB according to MD approx 30 spots were present & atypical of what an allergic rxn to measles would look like;
left arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Latex. The patient's concomitant medications were not reported. On an unspecified date, after the 1st shot the patient experienced.  left arm soreness and fatigue. The outcome of the events was unknown. The patient received treatment for the events. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient received second dose of bnt162b2 (lot number: EL3247) on 04Feb2021.   No follow-up attempts are possible. No further information is expected.
day p/vax pt exp diarrhea, liquid stools, approx 10-12 a day. crying w/stooling, otherwise happy, alert, active. increased gas noted.  changed formula
Arm pain at site of shot the same day. 1.5 days after shot, headache and dizziness started.  Have had dizziness and headaches since Friday 9/17
The following day I woke up with a fever of 101 degrees, muscle aches, fatigue and unable to do anything except sleep. The fever broke during the night - then I awoke the following day feeling back to normal.
24-36 hrs after mom describes hives x 4 d. 7 d after abdominal pain - felt due to constipation.
Moderna Covid-19 Vaccine EUA swelling and redness on arm around injection site fatigue
Moderna COVID-19 Vaccine EUA  slight nausea within a couple hours of getting shot yesterday. Gone by this morning.  Around 9:00 this morning, I noticed I was having trouble typing.  Looked down at my hands and both hands were severally swollen, to the point that  I could not even make a fist.  This swelling lasted about three hours.  Swelling started to subside around noon and is completely gone now, at 2:30 in the afternoon
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. Patient took COVID 19 Treatment of Paxlovid from 30Dec2022 to 05Jan2023. No known allergies. Device timestamp: 12Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a woman in a medical center concerning a 2 month old male who on 3/9/00 was vaccinated and that same day, the pt became lethargic. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, Loss of L shoulder abduction, flexion Narrative:  Other Relevant History:
reconstituted with a sterile diluent instead of the supplied AS01b diluent; reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter was clinical operations manager reported that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They were not sure which patient it was that received this dose, they had it narrowed down to 4 patients.  The dose was given sometime between 5th August 2023 to 22nd August 2023. At the time of reporting, no repeat doses had been administered. The reporter consented to follow up. This was 1 of 4 case, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116986:same reporter US-GSK-US2023116324:same reporter US-GSK-US2023AMR116985:same reporter
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 79-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, weakness, nausea, diarrhea and muscle pain. On 22nd April 2018, the outcome of the tiredness, weakness, nausea, diarrhea and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness, weakness, nausea, diarrhea and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was tired, weak, experienced severe nausea and muscle ache. No follow up was requested. No further information was available.
Redness and swelling of site. Also headache and fever. Next day patient left work early. Went to the Dr. Took IBU and Tylenol #3.  Returned to Dr. 5/12/2017. Was administered steroids. Patient still had a fever.  Went back to the Dr on 5/14/2017 complaining of worsening swelling down to the elbow. Patient was given Keflex. Today patient is feeling better and has no fever, but can still feel a 'knot' at the site.
Fever 102.2 - 103.5 -  no redness at site received HIB, PCV7, PEDIARIX 8-5-08 at Dr office vomiting yesterday and today
DEATH; BREAKTHROUGH COVID CASES; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient by other company (Pfizer Inc.) received on 23-JUL-2021 and concerned multiple patients. No past medical history or concurrent conditions were reported. The patients 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, 1 total administered for prophylactic vaccination. Concomitant medications included bnt 162, and mrna 1273. It was reported that there were 4450 breakthrough Covid cases. Among 4450 cases, 247 patients were hospitalized for suspected Covid 19 infection and 79 patients died among the population who were fully vaccinated by Pfizer or Moderna vaccine both doses or Janssen vaccine one dose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of breakthrough covid cases and suspected covid 19 infection was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:20210756412-covid-19 vaccine ad26.cov2.s-death,breakthrough covid cases. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210756412-covid-19 vaccine ad26.cov2.s -suspected covid 19 infection. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.; Reported Cause(s) of Death: CONFIRMED COVID-19 INFECTION
I got a bad headache for about 30 hours. I also had body aches and naseau and difficulty sleeping.   I am currently pregnant and was 12 weeks pregnant on the date of the second dose of the vaccine (est date of delivery 10.21.21)
pt recvd vax 5APR93 & on 6APR93 pt devel fever & itchiness all over which lasted approx 24 hrs; pt was not administered any medications & subsequently recovered; No further details were provided;
24 hours after 2nd vaccine -- chills, flu like symptoms.  36 hours after 2nd vaccine covid arm appeared.
Pain on my arm for many weeks, little swelling, when arm healed,  my back began hurting and I developed a rash, was told it was nerve pain began 4/27/2021 Diagnosed with shingles on may 6th I still have some residual muscle pain as of 05/26/2021
This spontaneous report received from a pharmacist refers to a female patient of unknown age. On 31-OCT-2013 the patient ws vaccinated with ZOSTAVAX (dose and route not reported). The reporter stated that the patient was being prescribed prednisone on 15-NOV-2013 for an unspecified reason. It was unknown whether the patient sought medical attention or not. The outcome was unknown. Additional information has been requested.
left arm itchiness 15 minutes after vaccine.  No other reactions. No rash, sob, chest tightness etc
On 2/4 it began with severe pain from behind my left ear radiantly upward to the top of my head.I have numbness on the left side of my face with mouth distortion (only opens to right side)My left eye does not blink or close.I tape it close nightly per MD.
The area where I received the booster still hurts a month later. It hurts to the bone and stings to the touch.  Immediately after the shot, the left arm, which didn't receive the shot, hurt more than the injection site.
One week after the vaccine was given, I suffered from a rash at the injection site. It was not itchy just red and warm to the touch. I had no fever or any other symptoms. A week after this (1/25) I suffered from an irresistible itch on my upper inner thighs and groin area (external, vulva) and on my chest between and under the breasts. I scratched and it made the area swollen, red and raw. I have taken Benadryl and that helped calm the swelling and itching. I've applied creams, petroleum jelly, coconut oil and keep the area clean. As of today (2/10) I have no swelling but my upper inner thighs are still red and peeling skin, I still suffer from itchiness but it's tolerable. Chest area rash has diminished.
I am currently on 60 MG of Prednisone and suffer from extreme fatigue and loss off muscle function , severe rash to varies areas on my body. Difficulty swallowing, weight loss, fatigue among other symptoms.
I received a series of 3 anthrax vaccinations at unknown dates during this time period.  On the first and third administrations, I briefly lost consciousness within 5 minutes of receiving the vaccine.  I also felt nauseous for the rest of the day and weak for about two days.  On the second administration, I remained reclined after receiving the vaccination and did not pass out.  However, I did feel nauseous the remainder of the day and weak for about two days.  During the time after receiving the vaccines, I felt generally weaker and had unexplained pains and dizziness.  My physical fitness test scores dropped markedly even though I was doing the same amount of exercise and conditioning.  Over the course of the last decade, I have sought treatment for chronic fatigue on several occasions.  All lab tests, such as thyroid tests, came out normal.  Within a few months receiving the vaccine, I suffered a hypomanic episode followed a few months later my a moderate depressive episode.  These episodes intensified and became more frequent in the next ten years.  Eventually I had a full manic episode with psychotic features, and was diagnosed with Bipolar I disorder.  I have been treated with individual psychotherapy, bupropion, Abilify, Seroquel, divalproex, Prozac, Lexapro, Celexa and Zoloft.  None of my relatives has been diagnosed with or shown symptoms of bipolar disorder, and I did not suffer any mood events or psychological problems prior to receiving the vaccine.
#AB659 is a legacy vote and legislators should know what Merck knows but is hiding from the public in their sealed documents; This spontaneous report was received from a consumer on a social media via Agency, regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unspecified date, the patient was vaccinated with either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strengths, dosages, dose numbers, vaccination scheme frequencies, routes of administration, anatomical sites of applications, lot numbers and expiration dates were not provided) as prophylaxis (reported as "Help protect against certain HPV-related cancers and diseases").  On an unspecified date, the patient experience unspecified adverse event and the legislators wanted more information from the manufacturer.  At the reporting time, the outcome of the event was not reported. The causality assessment between the event and the company unidentified HPV vaccine administered was assessed as related.
approx 10 mins post injection, staff called for client to have medical eval.  Client has c/o slight tingling in left leg
Redness, pain, warmth, burning at injection site and pain in left arm starting 11 days after receiving vaccine
On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy).  Had to have help to & from wheelchair and bed.  Much worse Thur, Fri.  By Sat. he could not move on his own from chest down.  Convinced him to go to ER on Sunday.  Paralyzed by PM 10-05-08.  Transferred to hospital 10-05-08, put in ICU AM 10-06-08.  Code blue (heart failure 10-10-08).  See med. reports (Also I kept diary) too numerous.  9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis.   Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired.  10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
Sore glands in neck, headache, muscle aches, shortness of breath that started approximately 5 hours after injection. Symptoms subsided by this morning.
Pt received Hep A in right arm, Hep B in left arm. Pt experienced mild pain upon injection in right arm followed by more severe pain the next morning. Left arm pain started several days later. Pt went to ER on 5/24 and was evaluated and discharged with rx for ibuprofen and note to be off work. Pt returning to dr on 6/22 for reevaluation of continuing pain.
Swelling at the site of injection, headache, brusing, itching, feeling ill.
Whole body was trembling like she was in shock, Parkinson's like; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Whole body was trembling like she was in shock, Parkinson's like) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lung disease and Neurological disorder NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TREMOR (Whole body was trembling like she was in shock, Parkinson's like). At the time of the report, TREMOR (Whole body was trembling like she was in shock, Parkinson's like) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 7.5 (Inconclusive) antibody test results were 7.5..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resulted in unable to work 3/16/2021 and 3/17/2021.
A patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 25-APR-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)  (LIQUID PEDVAXHIB) one dose, lot # R021078, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # R028189, expiration date 06-JUN-2020 , for prophylaxis (strength, dose and frequency were not reported).  The temperature excursion was of 52.5 Fahrenheit degrees (°F), during 4 hours 40 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.