chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fevers, chills, low back pain, rash/hives persisted for 2 weeks.  Multiple visits to ER. Labs not impressive aside from AST/ALT elevation.  Symptoms immediately gone after steroids and now on tapering course. 12/07/09 ED records received for DOS 11/22/09. Pt presents with fever x 15 days, cough, congestion, retrosternal pain, urinary frequency, back pain. DX: urinary tract infection 12/07/09 ED records received for DOS 11/25/09. Pt presents with continuing fevers x 18 days; has been on antibiotics. Also c/o nausea, belly pain, constipation, neck and shoulder and flank soreness, headache, red blotches and itching. DX: acute fever x 18 days; abnormal lymphocyte count; rule out serum sickness; yeast vaginal infection; muscle pain 12/07/09 ED records received for DOS 11/28/09. Pt presents to f/u on bacterial vaginosis. Has abdominal pain and diarrhea. Took Mag Citrate in am for constipation 12/08/09 PCP records received for DOS 11/24-11/25/09. Pt presents with fever chills nausea, headache, body aches, abdominal pain x 17 days. Taking Bactrim for UTI. States intermittent urinary frequency. DX: Viral illness, resolving UTI; folliculitis 12/08/09 PCP records received for DOS 11/09/09. Pt. presented with body aches, nasal drainage, cough X 1 week. States several hours after receiving vaccination body aches worse. DX: viral illness.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 3-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 15th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, injection site pain and chills. On 15th March 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the general body pain, injection site pain, chills and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the general body pain, injection site pain and chills to be related to SHINGRIX. Additional details were reported as follows: The 3 years old patient received SHINGRIX, which led to inappropriate age at vaccine administration. No additional information was provided.
This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L013546; expiration date 17-JUL-2016), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved.
Two days later woke up with double vision in left eye.  It was diagnosed as Cranial Nerve 6 Palsy.
Injection given into right shoulder joint causing extreme pain. She ended up with a tear in her rotator cuff and pneumonia. Causing her to be admitted the the ICU and placed on the ventulator
Within 24 hr of VZV there is warmth and tenderness <2cm. This reaction seems to be with our booster VZV. No reaction seen with primary VZV.
Pt recv vax on 1/28/99; on 1/30/99 pt exp fever (102-104); tx=Ibuprofen, Amoxicillin; pt im 2/1/99
103 temperature, seizures, vomiting, feeling like the bones were broken in my neck. I did not make it into the ER
Pain in left shoulder afternoon/evening of shot. Muscle aches all over starting in afternoon and continuing until second day after shot. Chills, but no fever. Generally feeling weak and tired. Felt bad enough morning after shot to stay home from work 1/2 day.
her whole left arm was hurting with the first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9599, expiration date: 31Mar2021), via an unspecified route of administration on 26Dec2020 in left arm at single dose for COVID-19 immunization. Medical history included overweight, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported.  The patient stated that her whole left arm was hurting with the first dose of the vaccine on 26Dec2020. She stated that she took a couple of ibuprofen (ADVIL) for event.  Outcome of event was recovered on 28Dec2020.
C/O difficulty swallowing about two hours after Influenza High Dose vaccine was given. Along with c/o left hand swollen and purple and increased warmth to touch.
My adverse event started on 01/16/2023 in the morning. I had fatigue, troubling losing weigh lasted entire month of March. On 03/11/2023 severe fatigue, forgetful, fever, mood swing, GI upset, upset stomach lasted through 01/17/20223. On 03/14/2023 labs (iodine, T2, T3 up take, TPO was high 650, THS 4.98, glucose, liver test, kidney function was normal, blood count/vitamin B12 normal. TRAB 2.07, were ordered. On 03/17/2023 I took it to my doctor's office who then diagnosed me as having Hashimoto Hypothyroidism. He prescribed me with levothyroxine. I will be on it for rest of my life. I am still mildly symptomatic because I just starting taking the new medication. I am still recovering and it hasn't resolved yet.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H0108796 and expiry date:24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Redness, swelling 4 inches x 4 inches, soreness and rash at the injection site.
Patient was given 0.25 flu vaccine. Recommended dose is at 6 months. Pts father notified. Twins did not have a reaction to vaccine. Father notified that this vaccine would not the infants.
Information has been received from a certified medical assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). The certified medical assistant reported that on an unspecified date, the patient was dying after vaccination with GARDASIL. It was unspecified if patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, the patient was dying was considered immediately life threatening. This is one of several reports received from the same source. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.
Severe fever and chills on 1/18 preceeding outbreak of shingles on chest and around to left arm/back on 1/30.  No prior shingle outbreaks.
Swelling, pain,reddness, and fever to Left arm,(Prevar-IPV): small amount reddness to right arm, DTPA-MMR.
fatigue, sweating, cough, chest pain, shortness of breath, rash on non shot arm, stomach pain, diarrhea, ball under injection site, muscle and joint pain, strong chemical smell
Dose 1 : December 2020 / Dose 2: May 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 23-year-old male patient who received HBV (Engerix B) (batch number M4KE9, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received first dose of Engerix B in December 2020, batch no.: E97CH and expiration date-19th April 2021).   In May 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In May 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Engerix B, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient wants to know when to give 3rd dose. The reported batch number 4ke9 was not found in sales data sheet, hence was updated to M4KE9. The reporter consented to follow up.
Rash down injected right arm self admin BENADRYL 25 mg PO AM BENADRYL 25 MG PO HS.
Covid 19 (Pfizer -Biontech) booster dose 0.3 ml . administered  undiluted.  Patient was monitored  post dialysis  and  monitored  post discharge to home.  Patient did not manifest any untoward signs and symptoms. No adverse evens reported.
Adverse event started a couple of hrs after vax was given; arm became warm to touch & swollen greater than 50 cent piece. Neck also sore and swollen.
Menstrual cramps and vaginal bleeding as if on period, but not due for period. Prior to vaccine, period was extremely regular so this is abnormal.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: This was second dose. Patient's temperature was 98 degrees. I asked her if she had any type of reaction to the first vaccine and she said no. I asked if she knew what to expect for the second one and she discussed how everyone in her family had fever and headache the day after. I gave her the vaccine and 5 min later she told me she was a little light headed and wanted to throw up. I told her it was okay to go ahead and go to the restroom to vomit. She passed out at the bathroom door. called ED
This is a spontaneous report from a contactable pharmacist.  A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 24Jan2021 14:00 at SINGLE DOSE for covid-19 immunization.   Medical history included hypertension, covid-19 (prior to vaccination, patient was diagnosed with COVID-19), latex allergy.  Patient was not pregnant at the time of vaccination. Patient received covid-19 vaccine (lot number: EJ1686) Intramuscular in Left arm, on 02Jan2021 at 5:00pm, for covid-19 immunization and experienced only arm pain, chills, and tiredness, and headache. The first dose was much better tolerated. Concomitant medication included hydrochlorothiazide (HYDROCHLORTHIAZID), potassium chloride and calcium, colecalciferol (CITRACAL). On 25Jan2021 17:00, the patient experienced swelling at the injection site, injection site felt hot, arm pain, tiredness, chills, headache, nausea started at 27 hours (feeling bloated and nauseous), feeling unwell in general 27 hours after injection. The patient underwent lab tests and procedures on 26Jan2021, which included COVID-19 Nasopharynx: results pending.  The outcome of events was recovered. Patient did not receive any treatment for events. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
SWELLING, REDNESS, PAINFUL TO TOUCH AND ITCHING AT INJECTION SITE. STARTED 2-3 DAYS AFTER THE SHOT AND HAS NOT GOTTEN BETTER
1 day p/vax pt devel an inj site rxn characterized by erythema & edema which extended below the elbow;pt recovered in approx 1wk;
Pt. was told by doctor the vaccine was given in her rotator cuff. She has had injections, oral medications, and 6 months of physical therapy.
FELT REALLY FUNNY, SOMETHING DOES NOT FEEL RIGHT AND STRANGE FEELING; BLOOD PRESSURE WENT DOWN; SLEPT AND SAT UP IN NIGHT; HEART RATE WENT DOWN; COULD NOT LAY DOWN; TINGLY CRAWLING AND FELT LIKE SOMETHING CRAWLING IN HEAD; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the patient experienced felt really funny, something does not feel right and strange feeling. On 28-MAR-2021, the patient experienced blood pressure went down. On 28-MAR-2021, the patient experienced slept and sat up in night. On 28-MAR-2021, the patient experienced heart rate went down. On 28-MAR-2021, the patient experienced could not lay down. On 28-MAR-2021, the patient experienced tingly crawling and felt like something crawling in head. Laboratory data included: Blood pressure (NR: not provided) Low in 50s, and Heart rate (NR: not provided) Went down in 30s, Up to 42 before sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt really funny, something does not feel right and strange feeling, blood pressure went down, slept and sat up in night, heart rate went down, could not lay down, and tingly crawling and felt like something crawling in head on 31-MAR-2021. This report was non-serious.
He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine.   He came home and collapsed due to the fatigue which is not normal for him.   About 12 hours later his throat got scratchy, achy but doable.  He went to work and had to leave early due to flu-like symptoms, felt feverish.   Really bad aches now, and his breathing and heart rate are elevated right now.  Achy-like headaches.   He did take some Ibuprofen 800 mg and seems to be helping.  He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok.  He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy.    He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.
KNOT AT INJECTION SITE (2 INCHES IN DIAMETER); INJECTION SITE WARMTH; ACHINESS IN THE LEFT ARM; STIFFNESS IN LEFT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and pneumonia, and concurrent conditions included haskimoto thyroiditis, fibromyalgia, asthma, and allergies. The patient experienced ibuprofen allergy when treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced stiffness in left arm. On 19-JUN-2021, the subject experienced achiness in the left arm. On 21-JUN-2021, the subject experienced knot at injection site (2 inches in diameter). On 21-JUN-2021, the subject experienced injection site warmth. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in left arm, and achiness in the left arm on 21-JUN-2021, and was recovering from knot at injection site (2 inches in diameter), and injection site warmth. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Pt. complained of muscle pain in vaccinated arm/in area of bone radiating from elbow to shoulder on 1/10/11 advised to ice area take anti-inflammatory 1/12/11 reported much better only dull 1/14/11 much better - very slight. MD will follow.
Doctor described her condition as a sterile abscess. Her entire arm from wrist to shoulder was swollen and inflamed. Her doctor prescribed antibiotics.
Patient came in with hives. One at injection site and multiple all over body. Given BENADRYL in office, treated with prednisolone and ranitidine for hives.
pt recv vax 24FEB98 & noticed redness & swelling @ site of inj;nervous,to clinic 25FEB98 w/swelling under both eyes;c/o nausea & dizziness;urinary sx, frequency, urgency, pressure;T97.3;
Patient became sweaty and dizzy at 20 minutes. Over the next 15 min patient became dizzy, intermittently nauseated, sweaty, "heavy" feeling, "spacey" feeling, L chest spasm. HR 80s, BP 142/87, RR 16, no SOB noted or difficulty breathing. Patient transferred to ER at 1500 and discharged home feeling "tired" but no longer dizzy or nauseated at 1717. Given 1 g Tylenol IV in ER.
dysphagia; thyroid nodules; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (dysphagia) and THYROID MASS (thyroid nodules) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced THYROID MASS (thyroid nodules). On 22-Jan-2021, the patient experienced DYSPHAGIA (dysphagia). On 18-Jan-2021, THYROID MASS (thyroid nodules) had resolved with sequelae. On 24-Jan-2021, DYSPHAGIA (dysphagia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Ultrasound thyroid: abnormal (abnormal) bilateral thyroid nodules most of which are below 1 cm.complex cystic nodule of right thyroid measures upto 3 cm. On 19-Jan-2021, Diagnostic aspiration: negative (Negative) NEGATIVE FOR MALIGNANT CELLS.         No Concomitant medications were reported No treatment medications were reported. Upon internal review on 4-Aug-21, the age was corrected to 38 years.   This case was linked to MOD-2021-023596 (Patient Link).
Extreme fatigue, insomnia, headache, chills, nausea, fainting, elevated resting heart rate.  Symptoms began about 5 hours after injection, worsened for the following 34 hours, then gradually improved over the course of a couple of days.
DURING REM SLEEP - NIGHT TERROR; HALLUCINATION; DIFFICULTY WAKING UP FROM DREAM; PHYSICAL DURING DREAM. REQUIRED TRIP TO EMERGENCY ROOM FOR STITCHES IN ARM AND INJURED FOOT.
24 hours after shots knees and elbows were red and hot to touch. No temp. Went to Emergency Room and told was reaction from shots. Next day developed red areas in body and face-went back to ER and advised same. No treatment given.
No recollection of going to bed, woke up very fatigued and hot. Four hrs later developed painful swallowing. Too fatigued to get out of bed to take Tylenol, etc. Slept until 4pm the next day. Continued with severe sore throat, swollen neck glands and a high fever (but didn't take temp. Reports cervical glands still swollen on 8/6/12. Pt called to report these sx on 8/6/12, was not evaluated prior to this.  Was not in NH where vaccine when she called to report her sx.
Onset of flushing, dizzy upon position change and severe site reaction/pain reported 12 hours post vaccination. Recurring symptoms with chills, fever, site reaction/pain reported at 10 am that same morning, relieved some with ibuprofen and hydration. Fever and site reaction again that evening at 10 pm. Reports feeling better by 9 am today, 12-07-2018, 2 days post vaccination.
pt recv vax 31OCT96 & 2NOV96 pt exp about 20 general & erythematous vesicles;It was reported that pt was asymptomatic;
Patient was observed for 30 minutes post vaccination (drank Gatorade and water while waiting) and left facility. She reported feeling baseline and went shopping and ate a meal which included chicken.  Several hours after vaccination she reported feeling some tightness in her throat and itching on arms/ chest and noted rash on arms. She was driven by partner back to the vaccine administration facility and was immediately assessed by EMS on site. Rash on arms was noted. Vital signs per paramedics were not out of normal ranges. Due to airway concerns reported ongoing, rash, and prior anaphylaxis history, she was given epinephrine. She received a second dose of epinephrine. She was monitored ongoing until transferred to the ambulance for transit to the hospital.
3.5x1.5-2"  red skin around site of injection developed around site of injection within 12 hours and has persisted for 13 days.  2 days post injection - Initial soreness from injection diminished however the "red skin spot" was still sensitive and warm to the touch.  6 days post injection - a firm lump was detected under the "red skin spot".  Area became increasingly sore and itchy through day 9.  13 days post injection (today) -  Lump is no longer palpable. Sensitivity and itching has greatly reduced. Skin is no longer warm to the touch. Red skin still evident in approximately the same dimensions.
This non-valid spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JAN-2018, the patient was vaccinated with VARIVAX (dose, site of administration, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. Upon administration of VARIVAX some of the vaccination got in the patient's eye. No adverse effect were reported. No product quality complaint (PQC) was involved.