chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Like a rash reaction; it itches around my neck and on my face; It kind of comes and goes on my face; sometimes my face would be red and the next day it won't be there; I can still feel the itchiness around the eyes. They look like they are really dry; I can still feel the itchiness around the eyes. They look like they are really dry; Like a rash reaction; it itches around my neck and on my face; This is a spontaneous report from a contactable consumer. A 71-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date was not reported), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. Medical history included Plantar fasciitis on left foot, glaucoma, Allergy and thyroid (thyroid disorder-Taking Concomitant Product Euthyrox For Thyroid). Concomitant medications included levothyroxine sodium (EUTHYROX) 100 ug, bimatoprost (LUMIGAN) and dorzolamide hydrochloride, timolol maleate (DORZOLAMIDE/TIMOLOL [DORZOLAMIDE HYDROCHLORIDE;TIMOLOL MALEATE]) for glaucoma and cetirizine hydrochloride (ALLERTEC) for allergy. The patient experienced like a rash reaction; it itches around my neck and on my face, it kind of comes and goes on my face; sometimes my face would be red and the next day it won't be there. I can still feel the itchiness around the eyes. they look like they are really dry on unspecified date. Reporter stated "I had a Pfizer's vaccine (Unspecified Vaccine) almost 3 weeks ago, 14Jan2021, and I am having some; like a rash reaction and I don't know if it's from that or if it's something else, it itches around my neck and on my face. it is Pfizer BioNtech."It kind of comes and goes on my face, sometimes my face would be red and the next day it won't be there but I can still feel the itchiness around the eyes. They look like they are really dry." As treatment, the patient stated "Yes, I am using a cream not on my face; on my neck" Consumer stated, "Triamcinolone". Therapeutic measures were taken as a result of like a rash reaction; it itches around my neck and on my face. The outcome of the events was unknown.
nausea and headache starting after dose 1. headache persisted. after dose 2 complains of increase in severity of headache, fever and bodyaches lasting 2 weeks, vomitting and diarrhea lasting 6 days, confusion and significant fatigue, large cyst - possibly lymph node in groin/pubic area- resolved, developed rash at injection site that spread all over body with itching. Itching all over body has persisted now over 2 months, headache constant since first injection now greater than 3 months, continues to have brain fog, and new symptoms of chest pain and muscle spasms of pubic/rectal area
pt recvd vax & w/in 48hrs p/vax exp a rash on chest & neck extending to arms & back;rash lasted a few days;at first, pt thought rash was scabies, which was going around the children's facility where pt works
Patient came in for first dose of Pediatric Pfizer, and the medication didn't get diluted properly.
after receiving injection, pt developed a 102 degree fever and vomiting, the patient reports that these are the same symptoms that occurred when she tested positive for COVID-19.
Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB
Within 30 to 40 minutes intense itching in left eye, left cheek and left gum. Left eye swelled shut and left cheek swollen with 1 hour of injection. Minor itching of right eye and cheek. Patient took diphenhydramine for itching and swelling. No shortness of breath or swelling of tongue. Next morning left eye reopened, swelling of left cheek reduced. Over course of next 24 hours, itching and swelling pretty much resolved although lingered a bit through 48 hours particularly swelling of left cheek.
expired Daptacel was given to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old male patient who was inadvertently vaccinated with an expired fourth dose of 0.5 mL DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date: 18-Sep-2019 via intramuscular route in the right thigh on 23-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Extreme body aches (muscles), Chills, tired, swollen and hard lymphoids, headache, nausea, pain in lungs when breathing.
I recently came close to losing my life because of blood clots in my Lungs and Leg; I recently came close to losing my life because of blood clots in my Lungs and Leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: PULMONARY THROMBOSIS (life threatening), THROMBOSIS (life threatening), outcome "unknown" and all described as "I recently came close to losing my life because of blood clots in my Lungs and Leg". The events "i recently came close to losing my life because of blood clots in my lungs and leg" required physician office visit. Clinical course: The patient stated that he/she recently came close to losing his/her life because of blood clots in lungs and leg. The patient's doctors have not found a reason for the blood clots. The patient's question is whether the Covid Vaccine is causing blood clots in people that have had the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness and swelling at site of injection. Low grade fever and vomiting. TYLENOL, applying ice, and Ibuprofen. Pt was seen in office on 5/18/17 and was given prescriptions for KEFLEX and Prednisolone.
6/15/21 triage call: Patient called stating that for the past week he's been having some brain fog, pressure in his head and fatigue  6/16 /21 office visit: The patient has been dealing with pressure bilateral sides of the head over the past 12 days or so.  No visual change.  It is a pressure but not really a pain.  No sinus pain.  No difficulty with hearing, no tinnitus.  No balance problems.  He also is dealing with significant related fatigue.  Fatigue is present all day.  Brain fog.  Difficult to concentrate. 6/23/21 triage call-MRI Brain Pending. Pressure in head Not Better  6/25/21 er 7/6/21 pressure in head
This spontaneous report as received from a medical assistant refers to a 13 year old female patient with lactose intolerant and TRIAMINIC allergy. On 10-FEB-2014 the patient was vaccinated with the first dose of GARDASIL injection (lot # J009788, expiry date 17-MAR-2016), 0.5 ml, intramuscular. There was no concomitant medication or pertinent medical history. Immediately after administration (while still in the office) the patient experienced nausea, dizziness and low blood pressure. The patient became pale and possibly fainted. The physician observed the patient and the patient recovered 15 to 20 minutes later. No treatment was given for the event. Lab diagnostics studies were not performed. This is one of several reports received from the same source. Additional information has been requested.
4/5/21 Moderna shot #1 4/6/21 middle of the night (approx 12 hours after shot) woke up with loud ringing in right ear 4/6/21-4/9/21 - noticed ringing more in the right ear and onset in the left ear,  feeling of fullness, onset of brain fog, extreme fatigue, anxiety. Woke up in the middle of the night with heart racing almost nightly. 4/10/21-4/18/21 - continued tinnitus in both ears, fatigue, brain fog anxiety and onset of diarrhea, nausea, dizziness, depressive symptoms, heart racing in middle of the night. Slight vertigo episode on 4/17/21 when I attempted to lay on my back to do yoga. Was not functioning much at all during this window.  Lost significant weight.  Primary care and ENT saw nothing organic in ears. Did see slight hearing loss in both ears.  4/19/21 - Began acupuncture treatment which stabilized the dizziness/nausea/anxiety/depression.  4/20/21-4/25/21 - 2nd acupuncture treatment. Began to regain energy. Still slept long hours but able to function during the day. Tinnitus persisted. Anxiety still there but manageable. 4/26/21-5/5/21 - 3rd acupuncture treatment. Almost daily migraines, but I believe this is likely unrelated to the vaccine (due to barometric pressure changes).  I should note though that I had a very severe ocular aura that was more than ever before and did spike my anxiety.  Woke up a few nights with heart racing and one night drenched in sweat. Tinnitus persists. It's mostly noticeable first thing in the morning, during the day, if there's little to no background noise, and in the evenings. Beginning to slowly work my way back into light jogging and yoga but far from my typical practices.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 17:15 as dose 1, single (Lot number: HG4628) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing); "Suspected celiac" (unspecified if ongoing), notes: uspected celiac-not an allergy but similar/Cannot consume anything with cross-contamination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine administration date=28Sep2022,, vaccine lot number=GJ5342,, vaccine lot unknown=False, vaccine dose number=4,, vaccine dose number unknown=False), administration date: 28Sep2022, when the patient was 35-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech,, vaccine brand unknown=False,, vaccine lot number=32030BD,, vaccine lot unknown=False, vaccine dose number=3,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 19Nov2021, when the patient was 34-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine lot number=EP7534,, vaccine lot unknown=False, vaccine dose number=2,, vaccine dose number unknown=False,, vaccine location=Right arm), administration date: 19Mar2021, when the patient was 34-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine administration date=26Feb2021,, vaccine lot number=EN6198,, vaccine lot unknown=False, vaccine dose number=1,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 26Feb2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Negative, notes: I felt sick starting 19Oct2023 but tested negative using an at-home Binax rapid test; (20Oct2023) Positive, notes: I tested positive with covid on 20Oct2023. On this date a Binax brand at-home rapid test showed a very faint line (nearly invisible), while a Genabio brand at-home rapid test showed a very strong line and showed up positive within 15 seconds; (24Oct2023) Negative; (25Oct2023) Negative; (27Oct2023) Negative; (29Oct2023) Positive; (30Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
dizziness; Severe fatigue; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198, NDC number and expiry date: unknown), via an unspecified route of administration on 03Mar2021 at 10:00 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included radiotherapy. She started the radiation about 3-4 weeks ago and she had 10 sessions. She clarified that she finished the radiation treatments about 25Feb2021. She was 83 and was immune compromised. Concomitant medications were not reported. It was reported that on 03Mar2021, the patient experienced dizziness. She said in the morning it was better. She felt dizziness and she was wondering if that was normal. Till 08Mar2021 and it was still going on, it had subsided. She clarified it had not completely gone away, it was ongoing but improved. She said she also had a question; she was 83 and she is immune compromised, so these were not new symptoms to her. On 03Mar2021, she started with fatigue, extreme fatigue and a little dizziness and no temperature and maybe a little muscle pain but nothing to really be concerned with regard to the shot. She said the fatigue began right away after the shot and lasted for about 2-3 days. She reported that out from Wednesday to Thursday to Friday to Saturday that was 3 days she thought. She said extreme fatigue was recovered but she would say fatigue was ongoing but improved. She was scheduled for the second dose on 24Mar2021 which was a Wednesday, and her question was if it was possible to postpone the second dose about 10 days or 2 weeks and get it when she comes back after her trip because she was supposed to get the second shot a day before she travels. She asked if reactions to the second vaccine dose expected to be worse than they were from the first. The outcome of the events dizziness and severe fatigue was resolving and for muscle pain was unknown.    No follow-up attempts are possible. No further information is expected.
Symptoms: Severe chills in the middle of the night approx. 16 hours after vaccination. Aches and feelings of general malaise accompanied by mild fever at the 24 hour mark. Fatigue lasting at least to the 36 hour mark. Moderate injection site pain for about 24 hours. Symptoms of malaise generally resolved with 400mg of Advil, fatigue continuing.
arm is all swollen; it is red; she said it is painful at injection site she can feel lump; rashy; she said it is painful at injection site she can feel lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 24Sep2022, outcome "unknown", described as "arm is all swollen"; VACCINATION SITE ERYTHEMA (non-serious) with onset 24Sep2022, outcome "unknown", described as "it is red"; VACCINATION SITE RASH (non-serious) with onset 24Sep2022, outcome "unknown", described as "rashy"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Sep2022, outcome "unknown" and all described as "she said it is painful at injection site she can feel lump".  Additional information: Reporter stated, she was calling for her growing daughter. Her daughter had her Pfizer booster, the bivalent booster on September 21st and she called her on 24Sep2022 morning and said, her arm was all swollen and sent her a picture of it and it was red, and she said it was painful at injection site she can feel lump. It was a pretty big area that all kind of red and rashy and they were concerned, and we wanted to know what she can do about that and also, they just wanted to report it. Reporter was informed in case of any emergency can contact nearest physician/pharmacist. Reporter stated, they don't have time to call pharmacy since she was unable to get help. Her daughter was in pain. They don't know if that was serious or not or they have to try to call the hospital she guesses so next.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 hrs after receiving (GARDASIL, Hep A, TENIVAC) vaccines pt felt lightheaded, nauseous and was sweating a lot. Pt passed out for a few seconds, per dad he was jerking arms and legs. Pt doing fine now.
Approximate time hepatitis B given 2:20. Approximate time difficulty breathing 2:25-2:30. Complained of chest hot and shortness of breath. Became unconscious. Appeared to have a seizure. Emergency drugs administered. Ambulance called; went to ER. OK.
Patient presented with complaints of swelling and redness to left arm, neck, and breast, chest pressure, left arm pain. Was seen in ER and given Toradol and Benadryl IM but swelling and pain became worse after leaving so she returned 12 hours later.  She was placed on med/surg unit in observation at that time and given Benadryl po, Vancomycin IV, and Solu Medrol IV.
Fever, chills, extreme muscle aches. 102.5 degrees F temp w/ibuprofen. (L) arm at injection became large, swollen, painful, & red. Lasted approx. 1 week. Cellulitis, abscess.
The first shot that I received on 9/24/2021 was the first adverse reaction.  I started to itch in my upper torso and face.  I was so uncomfortable.  I was itchy all day long.  I can not take Benadryl during the day because it knocks me out.  I still had to function so I was uncomfortable all day.  I was itchy for a whole week.  The next week was not bad. THEN when I went to take the second shot, I told the Pharmacist about the itching but he brushed it off and said that itching is NOT a side effect, although the pamphlet that he provided to me said that it is.  You all might want to educate the person's giving the shot on the side effects.  THE SECOND DOSE was given o me on 10/15/2021.  I woke up the next day and guess what. Yes I was itchy, but it also effected my  reaction time and I felt like I was going in circles.  I felt dizzy and tired.  Yesterday was really tough.  I should not have been on the road.  I felt like I was going to blank out but i was not.  I spoke to my PCP about it.  She tried to prescribe me a medicine that would help with the itching and would not make me drowsy, but it interfered with my heart meds.  I also ended it with yeast meds because the itching was affecting my private area.  I do not have a yeast infection but she though that it would help the itching.  I feel like vaccine and I do not agree.  I am afraid to drive right now.  I an just waiting for these effects to end.  I have a headache that will not go away and my neck hurts badly.  My stomach feel like I am on a boat constantly. I do not want ANOTHER DOSE of that vaccine.  I will now list Covid Vaccine as a medicine that I am allergic to.  You should not have to take a vaccine and turn
Clonic tonic seizure lasting less than one minute. Taken to ER. Occurred about 9 1/2 hours after vaccines given.
Was Sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Previously administered products included tetanus vaccine with an associated reaction of no adverse event.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to dTpa vaccine.     Additional Information: GSK receipt date: 24-JUL-2022 Reporter's comments: The case was reported by a consumer via interactive digital media Patient self-reported the case. Patient got a DTaP shot and was sick for a week.  Patient had went in for tetanus but was told this was better. Patient had tetanus before with no reaction never again.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022 at 2:03 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022 at 2:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 23-FEB-2022 14:03) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vaccine administration time was reported as 14:03:35. Patient received booster dose. The patient received moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. No treatment information was provided.