chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 19 October 2009 from a consumer. A 49-year-old female patient had received an intramuscular right deltoid injection of FLUZONE SV (lot number not reported) on 13 October 2009 at 17:00 hours from a multi-dose vial. The patient had received flu vaccinations for many years, and reported having a similar reaction (as mentioned below) when she received tetanus (date not reported). The following day after receiving the FLUZONE SV, the patient developed a blister at the injection site. The day after that, the patient developed a lump at the injection site. The next day after that, the patient's arm, face, neck and lips were swollen, as well as her right eye that was swollen shut. She also had blisters on her mouth and tongue. The patient was treated in the emergency room with intravenous steroids and PREDNISONE. When these treatments are stopped the swelling re-occurs. At the time of this report, the patient had not recovered. Documents held by sender: None.
I gave the patient an expired vaccine. The Varivax expired Oct 22/2021. Merck indicated that in house data shows at supposed time of administration potency remains the same. No recommendation to be  revaccinated as long as it has been stored correctly. Expiration window is ok based on their in house data stability information. I called the patient and she has no adverse symptoms and is fine since doesn't need to be revaccinated.
Pt c/o watery diarrhea commenced night after Anthrax vax. Two days later, he then c/o fronto-temporal headache, malaise, achy joints, mild nausea w/ no emesis, and low back pain. Given Aspirin the first day, then switched to Tylenol tablets 2 the following day.
This spontaneous report was received from a licensed practical nurse refers to a 9 month old patient. On 25-FEB-2013, the patient was vaccinated with 0.5 ml dos eof VAQTA (lot number and expiry date was not reported, route was intramuscular). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Joint pain 12/29/2021-1/1/2022, rest and sleep, Advil  Headache not staying in any one place 12/30/2021, 1/2/2022, 1/5/2022, rest, sleep, Advil Headache not staying in any one place, mostly in front near eyebrows and forehead, 1/3/2021-1/4/2022, Acupuncture helped a lot Fatigue, ongoing for days, 12/29/2022-1/6/2022, staying home from work, resting as needed (I experienced fatigue for more than two months after my second Covid shot on 4/9/2021, Acupuncture and massage, and time off work helped)
2 days after 2nd dose of Pfizer vaccine pt developed stuffy nose, SOB, but no cough, fever, or chills, then developed an itchy rash on Rt foot that spread to arms and legs resulting in a peticheal rash/lesions on dorsum of feet, shins, thigh, mid abdomen, medial arm and back.   Dermatology consult felt due to allergic purpura, and vasculitis possible but less likely.  Platlet count in the normal range.
pt recv vax 10APR97 & mom phone 11APR97 pt had large red area, hot to touch on thigh;mom was concerned because older son had rxn on 4th DTP that caused cellulitis that required IV ATB;pt seen by MD & given med;
Arm /shoulder warm to touch, swollen size of lemon at first, itchy, in area where shot was given, Second day less swollen, pt washed with hibiclens and will take benadryl
Patient came in 10/28/10 stated he and his wife received flu shots about 3 week ago and their arms were still sore - pt thought maybe vaccine was given too high in the arm.
Hurt worse than last year; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The age at vaccination was not applicable for this report. The patients received Flulaval last year and the reporter stated that it hurt. No call was dropped before getting further information about vaccines such as lot number and expiration date. No vaccination date mentioned. The reporter did not consent to follow-up. This case had been linked with US2021206241, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206241:same reporter
devel fever about 1/2 hr p/vax 101.4 ax; given APAP & fever reduced some l hr later face reddened & puffiness around eyes; given some DPH as grandmother said some family hx of DTP allergy; all sx gone by 3-4 hrs later;
No additional AE reported; the 1.5 year old child wiggled and some of the dose was not administered; This spontaneous report has been received from a medical assistant, referring to an 18-month-old (reported also as "1.5 years old) patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 18-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number U002539, and expiration date for prophylaxis (dose and frequency were unknown by the reporter; strength, route of administration, anatomical site administration was not provided). During the administration, the child wiggled and some of the dose was not administered (incorrect dose administered). The medical assistant reported that the physician followed up with the child's mother and she reported no adverse events from the administration
Patient is worried; Booster dose may have leaked out the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Patient is worried) and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Patient is worried) and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site). At the time of the report, ANXIETY (Patient is worried) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Reporter stated that when the patient removed the bandage there was orange cloudy liquid in the middle of the bandage.
On October 27, 2021, I had a stroke. I lost half my vision in my right eye. The vision was affected for over 30 hours.
Initially had arm soreness that resolved expectantly after about 2-3 days. Then 2 weeks after vaccination arm became even more sore and she experienced pain with movements.  No signs of infection from the injection site. No rashes, fevers/chills, signs of superficial phlebitis. This lasted for approximately 6 weeks.
This spontaneous report was received from  a healthcare worker (via company representative) reported on her niece, a 19 year old female patient. The patient's medical history, drug reactions, concomitant medication and allergies were not reported. On 22-SEP-2017 the patient was vaccinated with GARDASIL 9 (lot #, expiration date, concentration and dose were not provided), intramuscular for prophylaxis. On 23-SEP-2017, the next evening; the patient experienced high fever of 103F and elevated white blood cell count of 17000 (unespecified units). The patient went to an unspecified urgent care facility on the evening of the same date, where she was treated by an unspecified provider and prescribed an unspecified medication for the fever and also given an unspecified antibiotic. The healthcare worker reported that the patient did fully recover on 24-SEP-2017. The causal relationship between, GARDASIL 9, and the events was not reported.
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car,  "I thought I felt numbness in my cheek. It didn't stay, went right away.  My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal?  It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"?  It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
FACIAL/ORBITAL/LIP SWELLING; NO CARDIORESPIRATORY SYMPTOMS; NO TONGUE SWELLING; GIVEN 1 TSP OF BENADRYL BY MOUTH WITH GOOD RESULTS.
2-11-21 - 12:45 am called nurse line about severe headache and excessive pain following covid vaccination (took place 2-10, 10:30am).   By 5pm, right hand was experiencing extreme burning neuropathy, which then traveled down right leg into right foot, so arm, hand, leg, and foot were involved. No fever.   By 8pm, body aches were really bad, and the beginning of a severe headache was showing. Temperature was 96.8.  Headache continued to get worse - centered around area of previous head injury (1982) above and just behind left ear.   Left ear was red and hot. Over time, pain radiated down back of head and down back of neck on left side. Also into left eye socket. Continued to increase area, involving jaw on left side and to lesser extent jaw on right side - both TMJs involved. Pain was 9 on pain scale.  It hurt less to stand up - sitting and lying down made pain much greater. Because of fatigue and body pain, I had to stand and walk all night ? I was exhausted.   12:45am Called a nurse hot line. They told me I need to get to ER. I said I?m stuck ? I live on an island with no hospital and there?s no ferry at that time. Nurse said I needed to speak with an on call doctor as soon as possible.   Began calling on-call doctor 1am. (It appeared to me that, where my new doctor practices, didn't have an on-call doctor.) said to call back in 10 minutes if I didn't get a call from the doctor. Called at 1:15am, then 1:30am, 2:00am, 2:30am, 2:45am. Still hadn?t gotten a call from the on-call doctor.  Body temperature fell under 96. I used 2 different digital thermometers, and even tried a glass/mercury one, which when shaken all the way down, never moved (lowest register is 96). At the lowest, at 4:15am, my body temperature was 95 degrees.  Finally around 4:30am, I took  tramadol and wrapped my feet in a heating pad set on high. Was finally able to lie down, but extreme head and neck pain continued.   On-call doctor finally called me just after 5am. By then, my temperature was at 96 again. He said the tramadol was a good idea, and said to take another. Told me to keep an eye on my temperature. Spent the next 2 days in bed. I could feel the incredibly strong body pain moving from place to place in my body, like someone walking on a path. For the next 2 weeks, I was fatigued and had brain fog.   Because I heard that people had a stronger reaction to the second dose, I was apprehensive about it, considering how strong my reaction was to the first dose.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: Patient after 2nd dose of pfizer covid did not feel well minute it was injected. After 5 min he fainted, what seemed like a seizure. He slid off his chair which is mother was right next to him. She says he had not taken his AM seizure dose and it looked like it was a grand mal seizure. He regained consciousness within a couple of minutes and stayed seated but said he felt out of oxygen, dizzy, and sweating. EMT called. They evaluated him. Then he was better. EMT left. He left out walking better
Wiped out after the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Wiped out after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Wiped out after the injection). At the time of the report, FATIGUE (Wiped out after the injection) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient experienced event for one and a half day.   Reporter did not allow further contact
This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Approx 8 hours after receiving injection headache began, went to bed. Woke up at 3 am aching muscles and head. Fell going to the bathroom. Able to get up and go to bed. Got up at 6 am, went to bathroom and fell in bathroom hitting doorframe causing black and blue bruise on right shoulder. Feeling very weak, sweaty, and shaky. Laid on floor x 15 min until able to get up and scooted over to sink and pulled self up and vomited x 1. Got back to bed. Felt weak, shaky and sweaty for the whole day. Feeling better after taking Tylenol for the achiness by the end of day. Felt weak and tired the following day but better.
patient initially admitted 12/28/2021.  Has had prolonged hospitalization with extremely slow improvement in respiratory status.  unclear if decompensation represents repeat COVID infection, or interstitial lung disease.  unclear if patient will have continued improvement related to post COVID fibrosis.  Poor candidate for transplant. Patient has been weaned down to 5 L of oxygen during the day, but requires 10 L with minimal exertion. Pulmonary has documented that 5 L O2 at rest is likely patient's new baseline  COVID-19 pneumonia -completed remdesivir 1/2, status post tocilizumab 12/29, continue steroids, Possible bacterial pneumonia -completed antibiotics,   Rehab placement attempted but denied by multiple facilities. Pt DC'd to SN facility DVT to Lt popliteal vein and rt peroneal.
Face numbness (left side, same side of vaccine administration), starting 5-7 minutes after injection. Lasted for about 10 minutes. Mild contraction of periocular muscles (right eye) started about 1 hour after shot and have lasted  for at least 48 hours after dose.
"Pins and needles" intermittent in right cheek and chin, fingers, lower legs and feet with increased duration of 5-10 minutes for the past 2 weeks. This in not a new onset but proceeded mefloquine. She was having similar symtoms 2-4 weeks prior to vaccines.
Acute inflammatory response of Bilateral upper extremity digits progressing to wrists and elbows painful and swollen joints
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/25/2021 and 3/2/2021.  Patient was admitted to the hospital from 7/20/2021 through 7/24/2021 with COVID.  She had some cough and an episode of fever.  She was not hypoxic.  Her chest x-ray did not show any pneumonia at that time.  She was readmitted 07/24/2021 through 7/28/2021 and again 8/4/2021 through 8/8/2021.  Chest x-ray on 8/4/2021 showed worsening diffuse bilateral infiltrates most suggestive of multifocal infection and/or edema.  While in the hospital, patient was treated with convalescent plasma, ceftriaxone, and doxycycline.  Patient expired on 8/8/21.
Information was received on 10-AUG-2017 from a nurse who reported that on 10-AUG-2017, the nurse (unknown age, gender, medical history or concomitant medication) who was administering the GARDASIL 9 vaccine (lot M042853, expires 17-JUL-2019) to a patient and inadvertently splashed the vaccine onto her own skin and eyes. No adverse effects were reported. No further information provided. Additional information has been requested.
On 04/15/05 Mother brought pt in clinic with left deltoid injection site red, warm to touch of tender, child had Tylenol PO. Enc. application of ice to site.
Heart pain.  Heart feels tight like iron barely pumping blood.  Extreme tiredness.  Can't eat.  Headaches
About 90 min to 2 hours after receiving the initial dose, my entire right side went numb. I could not walk and had limited or no use of my right arm and leg for several hours. Normal sensations returned that evening but I continued feeling burning, tingling and numbness on and off for several weeks afterwards. I am on disability as I suffer from chronic Lyme disease and I have existing peripheral neuropathy (among other health issues). However, the intensity of nerve pain skyrocketed after the shot and has not let up, even 4 months later. The day after I also began experiencing flu-like symptoms, migraines, body aches, stiff neck and general malaise for 2 more weeks.
Severe inflammation in right eye and right knee, seeing retina specialist sever inflammation in right eye very blurry had kennalog shot in eye and on prednisone 60mg  for 12 days.
sinus problems as well as chest congestion; MD stated patient was to have a allergy shot instead of the 2nd vaccine; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a physician via Agency (under the reference 00893233).  This case involves a 59 years old male patient who had sinus problems as well as chest congestion (sinus congestion) and md stated patient was to have a allergy shot instead of the 2nd INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 25-Oct-2021, the patient received a first dose of suspect FLUZONE QUADRIVALENT (0.5 ml, lot UJ705AB and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid and on 27-Nov-2021 he also received a second dose of the same vaccine (0.5 ml, lot UJ695AA and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious sinus problems as well as chest congestion (sinus congestion) (unknown latency) following the administration of vaccine.  It was an actual medication error due wrong vaccine administered (same day latency).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient was recovering from the event sinus congestion.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
fever & thrombocytopenia & rash hospitalization 17 days p/vax;
painful left arm immediately x 3 days.  Symptoms improved.  On day 7, left arm pain and mild rash
Patient seen 7/24/08.  Diagnosed with chicken pox on trunk, neck and arms.
CHEST PAIN, COSTOCHONDRITIS, VERTIGO,JOINT SWELLING EDEMA TO FINGERS,BRAIN HEMANGIOMA
Red rash around injection site. Arm was also tender (especially at night), warm and itchy. Itchiness preceded rash and lasted longer than rash. So did tenderness.
Patient fainted 10 minutes after Gardasil vaccine was administered. After patient woke up, cold packs were applied. Vitals were stable. Patient observed until recovery.
Patient was administered Pediatric Covid vaccine Lot HE2391 Expiration 4/24 instead of the Adult Comirnaty vaccine by mistake on 9/28/23 by immunizing technician.  Patient came back as soon as they could to receive Comirnaty as per CDC guidelines on 10/3/23.
Potential infection at injection site, patient was seen at an urgent care and was given antibiotics. Patient had pain, swelling, redness at injection site.