chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unkonwn gender. Since 02-APR-2015, the unspecified patients were vaccinated with GARDASIL (lot # K005881 and expiry date: 14-JAN-2017) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Asymmetric Sensorineural Hearing Loss (SNHL) in right ear,  Profound deafness. Tinnitus,
Mental fogginess, ataxia, lower extremity tremors, ocular migraines.
I could not breathe. My lungs was not getting air. I went to the ER. I had scar tissue in my lungs. Two weeks later my feet started burning. Nerve test was recommended.
did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of did not feel well in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 010M20A and 0062G21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ADENOSINE, METOPROLOL and ELIQUIS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced did not feel well. At the time of the report, did not feel well outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Heart rate: 135 beats per minute (High).         Treatment information was not provided.    This case was linked to MOD-2021-311007, MOD-2021-311047 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes On 13-Sep-2021 Significant Follow up, Concomitants were added.
pt recvd MMR vax 11 days ago & devel low grade temp 2 days ago & moribiliform rash (scanty) over the body yesterday; today face seems clean but pt still irritable a little;
3 hours after the vaccination I developed the worst headache I had ever experienced thus far in my life.  This headache began to decrease in its intensity after one day and gradually got better until after 2 weeks it was gone.  Since the vaccination, I find it much harder to sleep, and as a result of my inability to sleep, I have painful headaches every few months that last weeks at a time.
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 28-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 02-Jan-2011. On 28-Feb-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 04-Apr-2011 and incorporated into case: no late occurring adverse events.
After dose 2 not many symptoms till June 2021, had lupus many years. Severely anemic went to the doctor and then to ER July 2, 2021, in hospitalize hematinic anemia related lupus, blood transfusion and steroids. I still must get blood work checked regularly with Rheumatologist and hematologist. Medications were given to feel better.
Breakthrough case admission after 5 vaccines Pfizer 1/27/21 Lot# EL9261;  Pfizer 2/17/21 Lot# EL9265;  Pfizer 9/26/21 Lot# FF2587;  Pfizer 4/5/22 Lot# FK9895;  Pfizer 9/20/22 Lot# GJ5342
Positive for Covid using RT-PCR test with symptoms runny nose and cough; Positive for Covid using RT-PCR test with symptoms runny nose and cough; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 14:00 (Lot number: FF2589) at the age of 58 years as dose 3, (booster) single, administration date 15Mar2021 15:30 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 15:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021 14:00, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovering" and all described as "Positive for Covid using RT-PCR test with symptoms runny nose and cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive for Covid using RT-PCR test. Patient experienced symptoms such as runny nose and cough. Patient received no other vaccine in four weeks and did not have Covid-19 prior vaccination. Patient had no COVID prior vaccination. Patient was tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Immunization on 7/23/12 at 0900 and woke up next morning red, swollen RT arm to elbow. Itchy, no pain, moves it normally. Called 7/26/12 at 0900 swelling gone, redness resolving.
Dizziness: right after shot   Arm soreness and couldn't lift my arm, facial flushing, chills : after approximately after 5 hours Severe facial itchiness with red patches  on the face and neck: started next dat and last 3 days
Information has been received from a registered nurse concerning a 36-month-old white female patient with no pre-existing allergies or medical conditions, who on 17-JUL-2003 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 645049/0198N). Concomitant vaccine therapy included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 645406/0133N) administered SC in the right thigh. The patient was not ill at the time of vaccination. As per the patient's mother, on 05-AUG-2005 the patient started with one possible chickenpox on her hand. As of 08-AUG-2005 the patient had about 28-30 lesions over her body. She did not have a fever. It was noted that none of the lesions were infected at the time of the report. It was also noted that the patient had not been to the physician's office. It was noted that the patient's mother feels it is a breakthrough case of chickenpox. There were no relevant diagnostic studies or tests performed. The patient recovered. No additional information is expected.
This pt appeared to have a seizure, her eyes rolled back, crossed legs, pulled elbows, rigid spine, up under neck, after about 50 seconds, she became aware of her surroundings. Her pulse was 88 and resp. 24, blood glucose was 101, and she was pale.
5:30 pm dry cough, wheeze fast heart beat, chest tightness,  6:30 pm rash shoulder to shoulder chest took 1 Benadryl, called MD friend at approx 7 pm.  8pm sweating took 2nd Benadryl, 1-2am woke up eyes, lips swollen, rash worse and vommited three times, morning of 12/2 lethargic but no rash, no cough.
elevated resting heart rate, as high as 113, started about 8 hours after he received the booster shot.  Heart rate would spike whenever he moved.  His breathing was a bit shallow, but he said his breathing wasn't actually bothering him.  We called his pediatrician's after hours number, and they advised us to take him to ER.  ER gave him an EKG, but otherwise didn't do much after triage because they were very busy.  He went home after about 5 hours.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 23 years old patient who received vaccine FLUZONE HIGH DOSE lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Developed nausea that lasted 20 min and was improved with emesis and laying down. Patient was observed by EMS and patient made full recovery.
That night about 11 pm, my neck felt like I had scratched it, but I could find nothing. The next day, about noon, I felt stinging pain, as if I had been stung. I had some welts. As the afternoon progressed, I had more and more welts. They are pencil eraser size. I am taking BENADRYL, and using Cortisone-10.
Looks like a sunburn at the injection site extending to top of shoulder. Then turned white around injection site. Difficulty lifting or raising arm.
Patient reports redness, swelling and painful to touch at injection site on arm where PREVNAR was given.
Info has been received from an RN concerning a male child who was vaccinated with the 2nd dose of MMRII. The RN reported that in early 11/05, the pt developed mumps. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further info is available.
Warm to touch, redness, swollen deltoid. Treatment: cold compress to affected area.
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health care system as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 06-SEP-2016, the patient was treated at a health care system for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
99.9t x 4days;screaming began 1hr p/inj & cont until 3:30am;extreme tenderness cont approx 10days;MD notified but not seen;16AUG95 pt recv DT per MD orders;
No adverse reactions were/are seen as of 6/1/2023. Patient was given .5 ml of bivalen booster instead of the .3 ml that is indicated to be given.
pt has been crying uncontrollably for >3hr;appetite dec;leg sore;advised to give APAP or Ibuprofen;will not give pertussis in the future;20FEB97mom states pt no longer fussy no concerns;
This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with improperly stored doses 9exposed to 31.1 F for 8 hours 10 minutes) of LIQUID PEDVAXHIB (Lot # not reported) on an unspecified date. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested,.
Pt due for booster (half-dose) of Moderna, but I inadvertently administered 0.5ml by mistake. Tried to reach pt to tell her about it but no phone number available. Also called her insurance and they do not have a phone number either. Will get in contact with her doc to find out her number soon.
Flu shot administered approx 4:45 11/30/17. At midnight patient woke with vertigo/dizziness. Continued when sitting up until 12/4/17. Feels better. Instructed pt to contact MD if further dizzy. Left message w/pt after initial contact. Never called back.
It was Saturday (09/03/2022) night when I first start feeling a fever, then I woke up the next morning on Sunday (09/04/2022) with a high fever of 102 degrees and I was soaking wet with aches and sore throat, I decided to take a home COVID-19 test and tested positive, then I called my doctor and she prescribed Paxlovid as well as an anti-nausea drug that she advised me to take an hour before I take Paxlovid. By the next day of taking Paxlovid I went from feeling miserable to just feeling bad, I tested positive for 16 days straight and I also experienced chest wheezing , loss of taste and coughing for 10 weeks straight.
Hives started on 11/22/2022 After treatment of predisone, skin irritation returned; saw (dermatologist) who diagnosed dermographism.  Dermographism  requires me to take 2 Allegra a day to avoid significant flair ups.
there was general malaise; feeling a little sick; fever with booster; sore arm; pain in arm; I did get a headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (there was general malaise), MALAISE (feeling a little sick), PAIN IN EXTREMITY (pain in arm), HEADACHE (I did get a headache) and PYREXIA (fever with booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma (The patient had a history of lymphoma for which she is on a maintenance infusion.). Concomitant products included PRAVASTATIN, PANTOPRAZOLE, DEXAMETHASONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL), RITUXIMAB (TRUXIMA [RITUXIMAB]), COLECALCIFEROL (VITAMIN D3), CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN), MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and ONDANSETRON for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (I did get a headache) and MYALGIA (sore arm). On 14-Sep-2021, the patient experienced MALAISE (there was general malaise), MALAISE (feeling a little sick) and PYREXIA (fever with booster). The patient was treated with PEDIALYTE FREEZER POPS [ASPARTAME;CARMELLOSE;CITRIC ACID;FRUCTOSE;GLUCOSE;POTASSIUM CHLORIDE;POTASSIUM SORBATE;SODIUM BENZOATE;SODIUM CITRATE] for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, MALAISE (there was general malaise), MALAISE (feeling a little sick), HEADACHE (I did get a headache), PYREXIA (fever with booster) and MYALGIA (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody test negative..         The patient was also taking Cagament and Hygil concomitantly. The patient was again tested for antibodies after receiving the 3rd dose, which was also negative. The patient didn't had side effects from the first two doses. The patient experienced a fever, headache, and sore arm after receiving the 3rd dose. She said that the pain in the arm and headache started the same evening of the shot. The feeling of general malaise, fever, and feeling sick started the following day. The headache lasted for 1 - 1.5 days and the sore arm lasted for a couple of days. All other symptoms only lasted for a day after which she felt fine.
(PEDS) PEDIATRIC VIAL WAS NOT DILUTED-PATIENT OK.
This case was reported by a pharmacist and described the occurrence of injection site tenderness in a 70-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Diltiazem, Lisinopril + hydrochlorothiazide, Pravastatin and GLIPIZIDE XL. On 26 October 2011 "in the morning about 11:00" the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 27 October 2011, 1 day after vaccination with FLULAVAL, the subject experienced injection site tenderness. At the time of reporting the event was unresolved. The pharmacist considered the event was probably related to vaccination with FLULAVAL.
The patient came into the pharmacy on 4/18/22 @ approximately 2:20pm and received their 4th Moderna vaccine booster. At the time of vaccination all the proper SOPs were followed and the patient did not report any side effects to the pharmacy staff prior to leaving after the vaccine. The pharmacy staff was later notified that the patient had passed away at approximately 6pm later that day. The family did not provide/disclose if a cause of death had been determined.
Swelling, warmth, redness where shot was given.  Persisting 5 days (so far). Slight itching ocurred also.  No treatment.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug information was reported. Patient age was reported as 21 years and 6 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number code was reported as 80777027399. No treatment drug information was reported.
1. Day 1 -- Immediately started feeling dizziness,  weakness and  sickness. I can not think clearly. My body was cold.  Too weak and dizzy to walk. I stayed in a bed for about 40 minutes. Couldn't drive, At that night I had pains all over my body. 2. Day 2 -- Still felt dizzy and had mild allergic reaction: my eye areas were reded, swallowed a little  and itchiness on my eyes and around them. See floats. Still couldn't drive cos of the dizziness. 3. Day 3 -- Still feeling dizzy and tired. Floats are almost gone.
Patient experience redness and blistering at site of administration. Just over 24 hours after injection.
Patient felt itchy and developed a rash. Rash was red skin discoloration. Rash was not consistent with hives. Patient was given benadryl and offered transport to the hospital. Rash improved with benadryl within 10 minutes. Patient refused transport to hospital.
Bronchitis 2 wks after 1st shot. Joint Pain after 2nd shot. Pneunomia after 2nd shot 1 1/2 month later. Respiratory Problems 4 months later. Muscle and joint pain continuously now. Short term memory not good. Diagnosed with Gout now.
Experiencing chills, fever over 101 degrees, soreness  and redness just above left leg ankle area.  Also soreness/ pain in upper inside thigh area Just took 3 ibupropen about 11 am
My skin is itchy all over my body. From my head to my feet. Hives on my elbows and thighs.  Began taking Benadryl on 9/20. Doctor prescribed me prednisone on 9/21.
Pt recvd vax on 23MAR92 & the next day, devel serum sickness w/severe arthralgia & severe pain & was unable to walk; @ time of report pt had arthritis & arthralgia;
On 18 September 2007 the patient awoke rigorous with fever and chills at 2100 and reported to medical.  The patient's temperature was 99.2 F and he was then treated with two 325 mg tablets of Tylenol PO and advised to return to medical if Signs and/or symptoms worsened or persisted.  On 19 September the patient presented to medical with fever, chills, a temperature of 99.8, a B/P of 170/89 and a pulse of 101.  Patient was found to be orthostatic.  Patient was treated with 800 mg Motrin, 160 mg Diovan (Previously prescribed to the patient) by mouth, 1 liter of NS and 24 hours Bed rest.  Signs and symptoms have resolved on 20 September 2007.
This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) for an unknown indication. On 4th January 2022, the patient received the 1st dose of Havrix 1440 adult. On 4th January 2022, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown. Additional details were provided as follows: A healthcare professional enquired if there were any side effects after giving a Havrix vaccine 1440 units to a child 2 years of age and what was the earliest age they could give the Havrix 1440 Units. The healthcare professional disconnected the chat after he/she was asked for credentials and before was able to confirm that there was or was not patient involvement. Later a nurse reported that a 2 year-old patient was given an adult dose of Havrix as a first dose of the immunization schedule, which led to adult product administered to child and overdose. The reporter consented to follow-up.
I had a pretty bad tooth ache that lasted a couple days. Going to see my dentist on 10/28/2021.
pt recv vax;lab eval: 11 neg titers 6-7 wk p/ vax;devel lesions;
Last two menstrual cycle starting after the booster shot on Dec 31, 2021 has had an extraordinary amount of bleeding on the first two day.  I have never had this much bleeding at the beginning, during or end of my cycle.  My first cycle after the booster was horrible in January and then again in March.
Right deltiod felt "hot", swelling & redness increased over 2 days post injection.  Patient was examined by physician's office on 10/22/2009 and was diagnosed with cellulitis and placed on Cephalexin 500 mg QID by mouth X 7 days.
Received vaccine in afternoon, approximately 2-3 hours later the child developed systemic urticaria.