chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives x 2 days Wheezing decreased Epinephrine IM Benadryl IM Prednisone PO Zantac PO.  06/19/2007 MR received for ER admit for c/o development of a urticaric/erythematic rash over the past 72 hours with low grade temp of 99-100.  Seen prior to ER visit and txd with epi and Solumedrol, however rash progressed and child developed orbital swelling and lip swelling.    Initial PE showed mild erythema of the posterior pharynx, swollen lips and eyelids, no respiratory sx. Increased drooling.  Swelling resolved with Benadryl and Prelone. Impression:  Urticaric like rash with hx of angioedema, currently resolved.  Candidal rash.
24 hrs after vaccination developed "deep cough, chills, eye burning", stayed in bed for 3-4 days. Feeling fine now. Never checked temperature.
This spontaneous report was received from a other health professional (female patient) of unknown age, regarding herself. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medications were not reported. She reported that medication from a leaking GARDASIL syringe dripped onto her hands when it leaked from the base of a defective syringe. On an unknown date product quality complaint (PQC) was filled. Outcome of the event was not reported. No adverse effects were reported. Causality was reported as not related to GARDASIL. Additional information has been requested.
105°F fever; dull headache everyday; Tiredness; Chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERPYREXIA (105°F fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERPYREXIA (105°F fever) (seriousness criterion medically significant), HEADACHE (dull headache everyday), FATIGUE (Tiredness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERPYREXIA (105°F fever), HEADACHE (dull headache everyday), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (High) 105 °F fever.         No concomitant medications were reported.  Patient's primary vaccination was J&J.  Patient thinks that the adverse events might be related to seasonal allergies.  Company comment: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious event of hyperpyrexia and other associated expected, non-serious events following administration of the booster dose of the Moderna COVID-19 Vaccine. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient thinks that the events might be related to seasonal allergies. However, these events are not the common symptoms of seasonal allergy. Information has been requested to further assess the case.; Sender's Comments: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious event of hyperpyrexia and other associated expected, non-serious events following administration of the booster dose of the Moderna COVID-19 Vaccine. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient thinks that the events might be related to seasonal allergies. However, these events are not the common symptoms of seasonal allergy. Information has been requested to further assess the case.
dizziness/lightheadedness; the room was spinning; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021 the patient experienced arm soreness and on 17Jan2021 developed dizziness, lightheadedness, and the room was spinning. The patient wanted to know if she can take Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
slept a bit more than usual; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that on an unspecified date, her mother might have experienced some side effects (slept a bit more than usual) from the Pfizer Covid 19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
I felt ok and then about 7 hours later I had extreme chills, shaking uncontrollably, put heat on mattress pad, double up on clothes, turned on a heating pad and kept moving it around my body. I got up to urinate several times; I was extremely dizzy, my heart was racing, I finally broke out into a sweat - I thought I might have a fever but didn't have strength to get a thermometer. I actually lost 1.5 lbs I think from sweating and urinating. Not because of any diet. I was so weak. Felt like the worse flu I ever had and my heart was beating so fast. I could stand up for long period. I went back to bed fell asleep. Couldn't eat etc.. Around 2:00 this afternoon 3/14/2019 I finally started to feel better but still weak. Felt like I had been through the ringer sort of speak.
About 8 minutes after vaccination client fell and hit her head, she has a large lump to right side of her head. After hitting the floor patient begin to show seizure activity for about 1-2 minutes. BP 140/20 P62. Ambulance service on site and transported to Hospital for follow up care.
Pt recvd 2nd dose of vax 26OCT92 & devel inc SOB-was admitted to ER & treated w/Solumedrol; 2nd inject was life-threatening;
Increase in resting heart rate after injection. On June 20th, experienced Postural orthostatic tachycardia syndrome (POTS). Continues to have POTS
Information has been received from a registered nurse concerning an approximately 24 month old female who in December 2007, was vaccinated with the first dose of ROTATEQ and in March 2008, was vaccinated with the second dose. On 11-MAR-2009 the patient was tested positive for rotavirus and respiratory syncytial virus (RSV) at the same time. It was reported that the patient recovered both from rotavirus and respiratory syncytial virus (RSV) (date unspecified). The patient sought unspecified medical attention from a nurse. Follow-up information was received from a health professional concerning this 29 month old female patient (also reported as approximately 24 month) who on 27-DEC-2006, was vaccinated PO with the first dose of ROTATEQ (lot #: 655405/1113F) and on 09-MAR-2007, was vaccinated PO with the second dose (lot #: 656106/1233F). On 11-MAR-2009 the patient was tested positive for rotavirus. Additional information has been requested. This is one of several reports from the same source.
Patient describes local soreness and redness with swelling to left arm starting same day. On 1-8-19 she began to experience chills, fever and general achiness. The 3rd day she stated that she was experiencing swelling with a rash all around her neck and throat. She stated that it has started to diminish now and deferred an office visit but wanted to make sure SHINGRIX is listed on her adverse event lsit and is very unwilling to get the second booster shot. She was given signs and symptoms of anaphylactic reaction.
Patient reported swelling the size of half a softball, with redness that measured 4in in diameter per her eye. She was instructed to start on BENADRYL on the evening of 11/5/18, and follow up with her primary care clinic if symptoms had not improved/resolved by the morning. Upon follow up on 11/6/18 at 2:00 PM, she stated that her redness had gone down somewhat, but the swelling had remained. She had already followed up with her primary care physician and was going to continue BENADRYL and go to see her doctor if needed and instructed by the office.
Patient began to develop severe right lower quadrant abdominal pain 8 minutes after administered. Pain 10/10 throbbing, sweating. BP 158/84, HR 96, RR 15. Positive rebound tenderness. No nausea vomiting. No hx of similar pain.  Repeat vitals at 1245 HR 99, RR 21 BP 158/88, pain 8-9/10. EMS activated. Arrived by 1255, transported by EMS, pain improved ton4/10.
p/vax pt devel intense burning;devel hard lump, red, hot & swollen froming 1-2hr p/vax; increasing in size x 3 days;then reddened area size =25cm x 20cm;
I felt a little fatigued all day after the shot, but nothing more. As soon as 10pm (02/01/2021) came around I had a pounding headache. The most intense headache of my life. I also got an intense stomachache and it felt like I had an ulcer. That progressed to a low grade fever, chills, myalgia, and arthralgia. The myalgia and arthralgia were so intense that moving to stretch my legs was incredibly painful. I was also very nauseous. The intensity of the arthralgia and myalgia subsided around 8am on 02/01/2021. All my other symptoms continued until around 11am on 2/2/2021. I still have a headache and some muscle pain, but they are manageable.
THIS IS AN ADMINISTRATION ERROR REPORT, NOT ADVERSE EVENT REPORT. I spoke with a VAERS representative just prior to filing this report, to seek clarification on how to report this as it was not an adverse event related report. She advised to write in capital letters that this was an "administration error report", as you see in the first line. On Mon 12/19/2022, the patient arrived to our clinic to receive the flu vaccine and the moderna covid 19 bivalent booster at the same time. Unbeknownst to me, the moderna vial that I took out of the fridge had been used 3 days prior, on 12/16,2022, by another provider. The medical assistant, that Friday, had to leave work early due to a family emergency. The provider thought for bookkeeping purposes, not to discard the vial but to place it back into the fridge. She did write a note on a small piece of paper to accompany the vial. However, the vial was put back in the fridge with the cap on, the note was not taped to the bottle. It was later discovered by me on 12/20, on the bottom of the fridge turned face down. The note did not specify which vaccine had been used. On 12/19, I administered the flu vaccine in one arm, the covid19 vaccine in the other arm. There was no adverse event noted for the patient following administration of them. On 12/19, the provider from Friday had emailed the medical assistant to notify her to discard the vial. On Monday, when I arrived to the clinic, there were boxes everywhere. We also were busy with patient visits and phone inquiries. The MA spent most of Monday clearing out these boxes, while I handled the clinical side. Due to the busy Monday schedule, the MA did not read the provider's email until Tuesday 12/20/2022, which was when we discovered the administration mishap. We notified management, filed an occurrence report, and I also notified the patient. I also contacted Moderna to understand the next steps, filed a detailed report with them. They advised that revaccination was not necessary, and to monitor for potential infection in the patient which is what I will be doing.
INCREASED BLOOD PRESSURE, 152/90, DIZZY,  FEELING LIKE IM GOING TO FAINT,  SORE RIGHT BREAST
complaint of increased swelling, pain and redness at injection site and circumference of left are 3 days after second COVID injection right deltoid are measure 18.5inches  Left deltoid measured 20 inches with hardness and redness
Injection site pain on 2-5-2021 and headache  The following  was present on 2-6-201 Shoulder and upper arm and warm to touch.  Fear  / chills, severe  headache, body ache, loss of appetite, nausea.  On 2-7-2021 site injection pain  mildly present, mild to moderate headache body ache,
Patient was incorrectly given a high dose flu vaccination, although he is not age 65 or older (is age 60 at time of vaccination).  Patient had no adverse reaction to the vaccination.
This was the second dose of the Covid19 vaccine given about a month after my first dose. When the shot was given, my arm went immediately numb with pins and needles. The pharmacist said that a nerve may have been hit and that everything would be fine in a few days. Over the next few days my arm from the injection site to my hands was numb with pins and needles, extremely sore, swollen and painful under arm and down side and breast. A day or two later, I began experiencing numbness and pins and needles in my feet. This sensation (numbness/pins and needles/vibration-feeling) slowly traveled from my feet up my legs, into my buttocks, up my sides and back. The same started in my right hand as well, spreading towards my center, up my face. In the following days and weeks, this continued, along with pain, tightness, changes in vision. The arm that the shot had been administered in became heavy and dead feeling, as though weighed down by a weight. Left side of body felt especially numb and heavy. I had extreme exhaustion, and would sleep beyond my normal range, waking still tired, needing a nap after being awake for only a few hours, and falling asleep again in the early afternoon and evenings. During this time, I went to both walk in care and my primary care practice. They reported that there are no side effects to the vaccine but referred me to a neurology specialist. It took eight months to see a doctor (December). The neurologist diagnosed "acute onset peripheral neuropathy secondary to Covid-19 2nd dose." He ordered testing to rule out all other contributors (MS, Lyme, etc). After finding no other causes and having worsening symptoms, I returned for another visit in March. The new diagnoses was "small fiber neuropathy...as a complication of Pfizer vaccination." More nerve testing is scheduled for June.
Dose one of Shingrix almost 2 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, almost 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient was past due for dose two of Shingrix, which led to incomplete course of vaccination. The reporter could not provide patient demographics, lot number or expiration date.
30 min after injection - pt became hot - had difficulty breathing - chills- muscle spasms. Went to E.R. Pt was numb feeling - blurred vision - pt not sure what in ER - will send for report.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that, the patient experienced sore arm after both doses of Shingrix vaccine. Soreness seemed to be more pronounced after 2nd dose. The patient also complained of chills. These symptoms were lasted for a few days. This case has been linked with case US2018GSK161059, reported by the same reporter for the same patient.
The pt developed a red and tender area (3cm X 7cm) on right anterior thigh.
Mom reports got their shots, they were fine, fussy, gave motrin 6p, he woke up fussy just bf MN, mom gave tyl, then mom heard something on monitor early AM 5:26am, looked convulsing, bilat shoulder twitching/eyes up and back, arms up/shaking, they got him out into living room, called 911, around 5min, then clinched jaw and eyes still kinda up, couple min maybe, dad thought 10min, but less than that, lots of spit in mouth.  Plan is to monitor for further symptoms and then separate the MMR and Varicella vaccines at age 4.
Heart complication (was not explained) which needed a medical procedure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart complication (was not explained) which needed a medical procedure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown. Patient reported she underwent a procedure for an unspecified reason and hung up. Concomitant medications were not reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 at 11:40 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 18.50 hours (also reported 11 hours), -1 admin. The patient was not experiencing any known symptoms. This is one of several assistant from the same source. Additional information has been requested.
Entire left arm painful, nausea, vomiting, headache, hives, itching
Started with nausea, then chills, pain in the arm couldn't lift arm more then a few inches, fever 100,5 muscle pain, joint pain, back pain all lasted for 12 hours. After 24 stomac pain resolved by itself overnight. After that headache and back pain and muscle pain for about 12 hours. After that just sense of exhaustion and mild headache all treated with acetaminofen 1000mg 3 doses over 24h period.
About 1-1.5 weeks after the booster, I developed a "hot poker feeling: dense burning" on the left side of neck. Then, it spread to my left forearm half way down. It lasted for about a week or so and went away on its own. I currently take gabapentin for nerve pain anyways, but it wasn't helping. Also, I developed Grover's disease after the booster, was treated for it and its resolved for now. To this day, I still experience burning in my neck below my ear and I am unsure if that's related to previous nerve damage in my neck or the booster.
Patient's guardian was counseled on patient receiving flucelvax flu shot. Guardian declined going into immunization room during service. Patient confirmed he was expecting to get the flu shot. After flucelvax was administered, guardian stated patient wanted the covid vaccine and not the flu shot. Guardian agreed to administer covid vaccine on the same day of service.
approx 6 hrs p/vax pt didn't feel good ran temp of 100-101; arm @ site of inject was swollen & painful; slept alot; the next 24 hrs felt fine the next day & called MD to inform of reaction;
Site: Swelling at Injection Site-Mild, Systemic: Bandage was full of blood-Medium, Additional Details: Patient's guardian reports that pharmacist administered son's vaccination wrong because when they went home, his son's bandage was full of blood.  Per the patient, the person who gave the shot cleaned something over the bandage, but did not say anything or change the bandage.  The patient's guardian states that this should not usually happen if they carefully inject the shot.
This spontaneous case reported by a consumer, describes the occurrence of productive cough (coughing phlegm) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced cough (coughing phlegm) and fatigue. At the time of the report, cough (coughing phlegm) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-034212 (patient link).
7-15 noticed red eyes 7-20 high fever 7-21 high fever, seizure ER Dr. said mild case of Pneumonia  7-24 noticed a couple of white spots in his mouth and a rash on his head around his hari line and behind the ears 7-25 rash spread down his body, took hime to the Dr, he said out of time line for adverse reaction and said rash was from Meds the ER Dr put him on although he had been on them twice before with no problem
A week after injection, experiencing ?COVID arm? with fever that fluctuates between 99-101 degrees Fahrenheit. Sore collar bone on left side (injection was on left arm), but unsure if it has anything to do with the shot (soreness started the same day as fever). Taking OTC Tylenol ever 6 hours. Redness on arm increased in size today (day 2), and fever is still around 99 degrees.
Dizziness, hot flashes, upset stomach, headache and shakes especially prevalent for the first three days. Symptoms subsided for the next three weeks. Patient now reports having restless leg syndrome, which he did not have previously.
Received annual flu shot in right arm; 3 days later noticed slight arm pain which has progressed so that now when I put my arm at a certain angle, I get a sharp pain in my upper arm. (Can't use left arm for injections due to prior breast surgery).
Employee reports, having a upset stomach starting about 3 pm and was having hot flashes. Employee reports waking on 3/10/07 still with upset stomach and developed a rash to both arms and chest. Employee noticed the injection site was raised and red. Slight rash to arms noted today on  3/11/07 but no itching.
Developed hives covering chest and neck 4 days following vaccine. Hives have surfaced on and off since 03/16/21. Eyelids become swollen and itchy intermittently. Hives are warm and itchy. No other adverse symptoms observed.