chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dimpling at Injection Site; "Atrophy"; Swelling at Injection Site; Pain at Injection Site; Initial Report Received on 18-Aug-2020  An Employee Immunization Nurse reported to an Account Manager that a 32 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed experienced pain, dimpling and swelling at the injection site and atrophy.    Medical history included pancreatic cancer at 21 years old.  No concomitant medications were reported.  On 03-Aug-2020, the patient received the first dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021 and NDC # not reported) intramuscularly in the right deltoid with a 1-inch needle from a prefilled syringe at a clinic. No other vaccines were administered at that time. On the same day, the patient felt and saw dimpling at the injection site and swelling underneath.  On 18-Aug-2020, the patient was seen by a Nurse Practitioner at the clinic. The patient reported pain, dimpling and swelling to the Nurse Practitioner. She had felt pain and swelling under the injection site ever since the injection. The Nurse Practitioner noted dimpling at the injection site and swelling under the site and noted "I have never seen atrophy occur with a vaccine." An ultrasound of the area was ordered. The event was reported on the same day.  On an unspecified date, the patient stated that she was not surprised this happened to her, weird things happen to her all the time.  An ultrasound of the area was ordered.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
sporadic finger tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (sporadic finger tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PARAESTHESIA (sporadic finger tingling). At the time of the report, PARAESTHESIA (sporadic finger tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications was reported.   Reporter did not allow further contact
The following morning I felt nauseous and had a headache.  A week later (4/30) I noticed the site where my shot was done was swollen, red, warm, and itchy.  It seemed to be stuck in the muscle so I massaged it and it went away within the hour. I again felt nauseous and got a headache.  The symptoms went away later that day in both instances.
chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and feet completely numb more than baseline, chest (rib cage) pain when breathing, weakness, fell several times, LOC x 1, gas, crawled instead of walked at times, bloating, abdominal cramps, diarrhea every 1-3 hours, slept the rest of the time, was able to drink Gatorade, pedialyte, water, ginger ale for hydration, no vomiting,
At 11 am extreme fatigue, sore arm. At 1 pm fatigue, sore, inflammation, warm to touch injection site, temp of 100 with chills, sweats, and headache took ibuprofen. Continued throughout day and evening arm becoming swollen and more tender, difficulty moving and pain radiating to neck, shoulder, and clavicle on left side. At 9 pm on 1/12 my left hip and left calf muscles began to spasm and hurt and all other symptoms mentioned above continued.  Ibuprofen taken again.  I awoke frequently (barely slept) throughout night due to above symptoms and the muscle spasm had also turned into cramping that was almost constant. By 6 am on 1/13 I went to the ER. IV Fluids and IV Toradol was given. I was discharged home around 9 am instructed to rest and take ibuprofen.  I did feel better leaving hospital, but when Toradol wore off in afternoon the muscle spasms and cramps, sore arm, hip and neck began again. I emailed my primary doctor and he prescribed Toradol.
No menses for 3 months after last Pfizer vaccine; This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 06Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on an unknown date at 14:00 as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced no menses for 3 months after last Pfizer vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of no menses for 3 months and included treatment with medroxyprogesterone acetate (PROVERA) 10mg oral tablet to start her menses. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event no menses for 3 months after last Pfizer vaccine was unknown at the time of this report.
Pt experienced hearing loss and increased ringing, dizziness (when bending), weakness in joints, tiredness, muscle spasms / tremors in legs and arm.
Chronic fatigue syndrome; This case was reported by a consumer via call center representative and described the occurrence of chronic fatigue syndrome in a elderly female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced chronic fatigue syndrome. On an unknown date, the outcome of the chronic fatigue syndrome was unknown.   It was unknown if the reporter considered the chronic fatigue syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not provided. At the time of reporting, approximately 20 years before the patient received flu shot(formulation/brand name unknown) that contained thimerosal and the patient experienced chronic fatigue syndrome.  The reporter did not consent to follow-up. Caller notes stated that caller declined for prescriber follow up This case is linked to cases US2019083179 and US2019GSK088465, reported for the same patient.      Lab Comments: Lab test performed on an unknown date.
Diarrhea all day long.  My wife did the same vaccine, same time and she puked night of vaccination.
Swallowing problems, soreness in throat and only drinking nutrition for the past month.  No solid foods.  Lost 25#
He spoke about sound streams, fax burns/he felt like he had a zoom call in his head, it is damaging the structure of his life/thought crimes had been committed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "He spoke about sound streams, fax burns/he felt like he had a zoom call in his head, it is damaging the structure of his life/thought crimes had been committed".  Clinical information: Reportedly, the patient needed to have some questions answered about Pfizer vaccines. He went on about someone having access to his vaccine. He spoke about sound streams, fax burns, and access being granted to an unidentified source. Other things stated were that his vaccine was being meddled with, he had self-reported team members had been accessing, he felt like he had a zoom call in his head, it is damaging the structure of his life. He needed to secure the fault line in totality, how did she get ahold of the vaccine pin, didn't trust communication lines, didn't know if the county has access or kids have it, thought crimes had been committed, he had the vaccine injected and thought it would stop. He was being used as an experiment.  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 registered nurse concerning a 32 year old female who was vaccinated with the first and second dose of Varicella virus vaccine live in February 1999, and March 1999, respectively. Recently, the patient was found to have low for Varicella titers. Unspecified medical attention was sought No information is expected.
Cold sensation on arms; Puffy eyes; Slight/brief tingling; Cold sensation on feet; Occasional itchiness on different spots all over body; Injection site pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6206) via an unspecified route of administration in her left arm on 18Mar2021 at 13:00 (at the age of 23-year-old), as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced headache, injection site pain, occasional itchiness on different spots all over the body (no rash), puffy eyes, slight/brief tingling and cold sensation on feet and arms. The patient did not receive any treatment for events. The clinical outcome of events headache, injection site pain, occasional itchiness on different spots all over body, puffy eyes, slight/brief tingling and cold sensation on feet and arms were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient First and Last Initial combined and entered in First name field 2. Narrative sentence "Concomitant medications included multivitamins" updated as "Concomitant medications included multivitamin" 3.Vaccination Facility Country added as US.
Moderna COVID-19 Vaccine EUA Extreme hives covering waist, groin, legs Swelling of lips and tongue. Itching
Patient came to pharmacy day after receiving FLUVIRIN and PNEUMOVAX 23. Her upper arm to elbow was red and slightly swollen. Warm to touch.
Approximately 16 hours after vaccine, patient woke up in the middle of the night nauseous, and then passed out unconscious for about 1 min or more.  After waking up had a high fever for about 4 hours and headache. Has had a headache for 3 days following.
pt recv vax;grandfather noticed that "she did not look good". CPR was started & Emergency team called & pt transferred to hosp;
Huge red knot at injection site, fever up to 101, chills, body acne, headache
Client was accidentally given 0.25ml booster dose of Moderna instead of the full 0.5ml as part of his second dose.
Dizziness, swollen and painful lymph nodes, especially in armpit of right arm, diarrhea, tiredness, chills, headache, feeling unwell
VACCINES GIVEN ON 3/26/2008. (MENACTRA, VARIVAX, ADACEL, GARDASIL.  Patient Presented with Bells Palsy to ED on 3-29-08.  Treated with Acyclovir and Prednisone.  4/22/08 Reviewed ER medical records from PCP of 3/29/08. FINAL DX: Bell's Palsy Records reveal patient experienced left facial droop & numbness, HA, & unable to wrinkle forehead x 1 day.  Tx w/antiviral, steroids, eye ointment & taping.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # M041990 with expiration date 28-JUN-2019 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007715: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA011217.
Headache, fatigue, joint pain, injection site pain, lymph node swelling, fever, chills, sweats, neck pain, nausea
I had a sore arm and felt feverish for about a day.  On 02/04/2023, I had a fall due to my dog getting under my feet. The fall was not due to a medical condition. I contacted my doctor who referred me to a specialist. I did fracture my hip born but I am recovering without surgery.
The first vaccination he had gotten extremely tired and developed a migraine.  He started getting occasional dizziness, and feeling light headed.  He fell asleep and was very hard to wake up within an hour of getting the initial vaccine.  After a week, most of the symptoms subsided.  He still had the occasional dizziness and feeling light headed, and headaches but it was not as severe.  When he got the second dose on on all the symptoms intensified.  He started getting so dizzy that he could not stand up.  He was dizzy just sitting on the couch, when there was too much noise, or lights, and he started to get pounding headaches. He began to lose his balance and fall. We saw his pediatrician about the balance and dizziness issues.  His pediatrician stated that he she thought he must have labryinthintitus.  She said she had seen a lot of kids lately with it. At this point he could barely stand and walk with out feeling light headed and dizzy. She told him to take dramamine and that it would pass on it's own within a few weeks.  It was so bad that he could barely go to school.  She added hydroxyzine for anxiety and said that he is getting anxious about falling over and getting dizzy and it was making things worse.  The anxiety med did not help. He started being scattered, he seemed forgetful and confused at times.  On October 22 he passed out at school and lost complete consciousness.  He could not walk and they wheeled him out to my car in a wheel chair. I called his pediatrician and she advised us to go to the ER.  She said to take him home and let him rest and take him after he was rested.  I could barely get him into the house, he could barely walk or hold himself up. When we took him to the ER a few hours later after getting his strength back, they ran blood tests, did a chest X-Ray, EKG, orthostatic hypotension blood pressures, and gave him a prescription for a scopolamine patch.  They were all normal. They said that they did the routine syncope work up for him.  I told them about the labrinthititus and the covid vaccination.  They gave us referrals to cardiology and neurology.  Nose bleeds started that night 4-5 in a day lasted 20 minutes at a time. They went away when we saw the ENT and he ruled out the labrinthintitus with hearing tests and exams.  He discontinued the scopolamine patch.  Peditrician said that nose bleeds were normal and seasonal and she was wrong per the ENT.  Cardiologist said that EKG and Echo and everything else that he performed was normal.  Neruologist did an MRI and was normal.
Fainted x 10 seconds. Given juice, vitals stable. History of fainting during medical procedures.
Prolonged crying spell for hours after vaccine.  Has remained more fussy and easily cries for several days.  Wakes at night more often.
Pt vaccinated with Recombivax HB 3rd dose 24JUL90 on 27JUL90 developed a low-grade fever, elevated liver enzymes, splenomegaly, and jaundice. He was admitted to hospital & treated w/steroids for 1 wk. At time of report pt almost recovered.
Initial misuse report received from a healthcare professional on 06 January 2014. A 10-year-old patient of unspecified gender had received ADACEL on an unspecified date in July. The patient did not experience any adverse event. Documents held by sender: none.
Migraine headache for a week, had a MRI of the brain to rule out blood clots.   A torn rotor cuff that happened 10 years ago that was a no issue, became very painful and inflamed to the point of needing a Cortisone shot and MRI to see what is going on.
Date of Admission  08/11/2021  Chief Complaint   Weakness yesterday. Came to ED with his wife but there was a long wait in the lobby so he went home. Today weakness has subsided. Generalized irritation to groin and pubic area due incontinence.   History of Present Illness    The patient is a 84-year-old male with a past medical history significant for bladder cancer with prior cystectomy, hypertension, hyperlipidemia, type 2 diabetes, morbid obesity with a BMI of 43, who was brought the ER today due to generalized weakness and inability to walk.  He is not a great historian.  He states he was recently discharged from a rehab facility within the past week, and has been weak and unable to walk since leaving the facility.  His wife is been unable to care for him.  In the ER he did test positive for COVID-19.  States that he received both of his Pfizer vaccines in February.  He denies any cough or shortness of breath.  He is saturating well on room air.  He states that his wife at home has been coughing and short of breath.  Vital signs in the ER show the patient to be quite hypertensive with systolic over to 17.  Urinalysis with 2+ leukocyte esterase. Patient still admitted on day form submitted
This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not performed. On an unspecified date, the patients were vaccinated with a dose of improperly storaged VARIVAX, lot # M012992, expiration date: 14-MAR-2018 (strength, dose and route were not provided). No adverse event was reported. There was any product quality complaint (PQC) involved. Additional information has been requested.
31 hours after the shot all of a sudden I started to get very jittery and started having chills. I ate a banana and a glass of milk. The jittery feeling subsided in about an hour. The chills remained and I got flushed and felt like i had a temperature. My joints in my hands felt very sore and during the night my body muscles felt wore out. My left shoulder at the site of the shot was throbbing  bad. For some reason I had to urinate every hour for the next five hours of the night without ingesting any more fluids. By 7:00 AM I got to feeling progressively better and by 9:30 AM I felt like I had just had a very poor nights sleep. No more chills, fever, being flushed and the pain in my arm subsided substantially.
Arm swelled up and got really puffy around the injection site about 4 inches in diameter for 2 to 3 weeks before slowly going down. Her skin is still slightly discolored after the shot, and there is also still a lump about the size of a nickel where the injection was given. She had no systemic effects such as fever or itching.
Patient got a 3rd dose was not aware that he had already recieved a second dose. Patient and family was notified no intervention needed
Pt reported dizziness. Vitals: 126/67,74,22, 95% O2,98.1F Pt stable and released from the vaccination site.
As walking to chair to wait for any symptoms he said "that shot didn't feel right. He sat down and immediately broke out in a full body sweat, was very hot to  the touch, turned pale, felt dizzy and said he couldn't hear me. He said he felt like he was going to faint. My other son went to get help in the pharmacy and they got cold packs and water. He laid against my chest for about 5 minutes with symptoms still present and then said he thought he was going to puke. This is when we called 911. The paramedics came about 15 minutes after the shot and the sweating had cleared up but he was yawning and very tired in addition to still being pale. The took his pulse and BP. BP was high. My husband, an NP arrived then and took over his care and we decided not to go to the hospital. He never had trouble breathing.
slight sore arm and fatique after vaccine. the following evening, suddenly overcome by nausea, horrific headache, dizziness... managed to walk.. by grabbing onto furnture, 10ft to carpeted floor, collapsed, hit head  ( now have bruise/cut) .  symptoms eased enough in short tme to get to bathroom ( diahhorea) and  bed. stayed in bed for about an hour as symptoms subsided.
The vaccine was given in the wrong spot in my arm. It was given on the inside of my shoulder higher than my armpit by the nurse. I sent them a picture and they stated that they think the vaccine hit the deltoid muscle but this does not mean it was in the right spot. I consulted two MD's and multiple other vaccinators who all agree this is not the correct location for administration.
No adverse reaction, this was a medication error because it was administered too early. It is difficult to determine the cause of that error because it occurred more than 1 year ago. However, the subsequent doses could have been prevented by more education of resources. In summary a repeated dose (3rd dose) on 4/30/20 should not have been administered until 9/3/20 and was counted as invalid according to system due to not being 6 months from previous dose. Patient then came in for Hepatitis A on 4/7/21. This was administered (4th dose) due to previous doses being invalid and system forecaster recommending administration to complete series.  It was found that that our EMR care gaps section did not recommend administration on 4/7/21. ACIP recommendations state the following: "If the first and second doses of hepatitis A vaccine were administered less than 6 months apart, the second dose is invalid and should be repeated 6 months after the invalid second dose (7). However, if this repeat dose (the third dose) is administered anytime 6 months or more after the first dose, the series can be considered complete." In addition to needing to know extra resources, system forecaster should only be cautiously utilized unless it is updated to include ACIP recommendations. If it was, we could have prevented a 4th dose for that patient.
Patient passed out minutes after receiving vaccine for approximately 10 seconds, then became very drowsy, pale in color and began to sweat excessively.