chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid 19; tiredness; Her husband found her passed out again during this diagnosis; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) (seriousness criterion medically significant) and FATIGUE (tiredness). On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). At the time of the report, LOSS OF CONSCIOUSNESS (Her husband found her passed out again during this diagnosis) outcome was unknown and COVID-19 (covid 19) and FATIGUE (tiredness) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient did not take any medications or treatments, though she was offered Paxlovid.  Company comment:  This is a Spontaneous case concerning a 74-year-old, female patient with no reported medical history, previously vaccinated with other Moderna vaccines, who experienced the unexpected serious (medically significant) event of loss of consciousness, and non serios events of COVID-19 and fatigue. The patient had COVID-19 about 10 months after the administration of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine, used as a fifth dose. During this diagnosis, her husband found her passed out. She has had passed out after the second dose as well.  No further information on clinical course, investigations and treatment received was available in the report. Loss of consciousness is assessed as not related to vaccination due to lack of temporal association (latency too long) and since there is a better explanation, COVID-19 disease.  The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.   This case was linked to MOD-2023-749467 (Patient Link).   Reporter did not allow further contact.
PATIENT REFERS WEAKNESS IN RIGHT ARM (ARM THAT RECEIVED THE VACCINE), EXCESSIVE SWEATING. WAS GIVEN A CANDY, BEGAN TO FEEL BETTER.
I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any medications/ injections in the past and I was not worried about this one. I didn't take any meds beforehand besides my normal morning modafinil. I have no fear of needles.  I received the vaccine in the auditorium about 1:25pm. The RN did a fantastic job, went through all of the information, no pain at all with the injection. As I was sitting in my chair for monitoring, a few minutes in I began to feel very uncomfortable. I felt clammy/sweaty and kept shifting my weight in my seat. I didn't want to make a big deal of it at first because I worried it was all in my head. But I became more and more uncomfortable. I laid my head down on the little desk, no help. I closed my eyes, no help. About 10 minutes or so in I decided to ask if they had water available. I slowly got up and walked to the back of the room. I couldn't even get the question out of my mouth before the nurse told me to sit down. Apparently I was white as a ghost. They got a wheelchair and wheeled me to the space behind the auditorium. By then I was starting to feel like my throat was closing and I saw spots in my peripheral vision. It was kind of a blur from there. I tried to take deep breaths. I drank a few sips of water and poured some on a paper towel to wet my forehead (and spilled all over my lap because I was a little disoriented at this point). My BP was 60s/40s and then 60s/30s. A rapid response was called. They moved me to a cart flat on my back with my legs elevated. My fingers and toes were starting to go numb and my lips were apparently blue/ white. After laying for a few minutes in Trendelenburg my BP began to resolve and my breathing started to ease a bit. No further intervention was done by the rapid team. I was taken by the Rapid RN to the ED for monitoring. They eventually pushed the cart into a room and took some vitals and an EKG. They had me stand and move to a wheelchair. I felt horrible but improved from before. They had me sit in a wheelchair in the lobby for a few hours before taking me back and placing an IV and drawing labs (I believe it was 3 hours from the initial reaction). I gave a urine sample. They then put me in a wheelchair and wheeled me back into the lobby for some more time. Then, they wheeled me back to a room where they gave some lactated ringers and a PA and MD saw me. By then my BP and breathing was completely resolved. The MD said he wasn't fully convinced it was just a vasovagal episode because I haven't had issues with vaccines in the past and I was well hydrated and my HR was normal. It partly fit the picture for an allergic reaction/ severe immune response d/t the feeling of throat closing, the BP drop, and the elevated WBCs. They advised that I list the vaccine as an allergy and do not get the second dose, especially since I had COVID back in September.
This case was reported by a medical assistant and described the occurrence of autism in a 3 year old subject of unspecified gender who was exposed to hepatitis B vaccine recombinant (Engerix-B) in utero. On 25 July 2002 the subject's mother received a dose of Engerix-B (dose number not provided, lot ENG5242A4). On 10 January 2006, the mother of the subject contacted the reporter and reported that she was one month pregnant at the time of the administration of Engerix-B and now her 3 year old child has autism. The outcome of the autism was not reported. Autism was assessed as medically serious by manufacturer. (OMIC)
pt recv vax & devel GBS & was hosp;no further info was available @ the date of this report;
Right arm swollen, red, warm to touch. Pt complained of itchiness-had DTaP immunization day before.
Pt. states that after receiving the 1st dose of Phizer 08/24/2021, started experiencing symptoms that evening of pain in all joints, headaches, muscle spasms, swollen throughout the body, and fatigue. Drainage noticed from the left nostril and eye.  Primary recommendation to not receive the 2nd dose of Phizer. Still experiencing symptoms.
It can bring on the gout; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographics) who had brought on the gout (gout) while he/ she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had brought on the gout (gout) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
headache; chills; This is a Spontaneous report based on the information received by Pfizer f(Manufacturer Notification to Pfizer/ Report No: -4797-8196). A contactable consumer reported for a female patient (reporter's colleague) that:  A 56-year-old female patient received (Pfizer COVID-19 Vaccine, solution for injection, Batch/ Lot Number was not reported) via unspecified route of administration as dose number unknown, single for covid 19 immunization. The patient medical history included insomnia, restless legs, fatigue, tired, cholesterol from unknown date if unknown ongoing. Patient is fit do exercises and has happy life. Family medical history includes mother's cholesterol is fine as well and her father did not die of a heart attack. she is concerned that the cholesterol medication can cause hallucinations, which she reports her "father was a victim" of (AE Capture US-#-10Sep2021). Past drug history included generic for Synthroid (Levothyroxine) for unknown indication started in 40s and therapy ended. The patient's concomitant medication included CombiPatch 50/140 two patches a week  via transdermal route from 2 years ago, 2019 still ongoing . that since starting she has had no side effects and she feels great and new treatment for hormone replacement for hormone replacement and medication for my Kidneys from unknown date. Patient cardiologists want her to get off of the CombiPatch and wants her to take cholesterol medication. On 10Sep2021 patient experienced headache and chills after Pfizer COVID-19 vaccine. Patient still had headaches. Patient received Moderna Covid vaccine from mid-day approximately 5 months ago, Apr2021 by 23:00 and she almost died after the second dose. She received the second dose and had symptoms. She passed out three times after receiving the second dose. Caller reports that she fell two times after the second dose. She reports that she did not pass out due to "unhealth" and reports that she was "normal" prior to receiving the 2nd dose. She also experienced a "very strong headache" and vomiting. It was "hell night" for her following her 2nd dose. She did not go to the hospital because she was afraid of contracting COVID-19 but did speak to her provider about the reaction. Her headache had not gotten better she would have gone to the hospital. She had to take the vaccine due to her kidney issues. The patient underwent kidney study with result(s): 39%, heart study with no calcification on her heart, blood work with result was perfect, cholesterol level are normal. Caller reports that she has no calcification in her arteries. Caller reported patient would take a third dose after eight months. The outcome of events were unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
7/16/2021 He came to ER. For weakness diarreah and incont issues. C-19 pos test upon admission. However he also tested C-19 pos in 5-03-2021
Patient complained of "puffed up" arm night of flu shot (10/20/05).  Patient used frozen vegetables as cold compress.  No meds taken for pain.  Next AM on 10/21, patient checked arm for swelling.  None noted. patient then noticed red, raised areas/whelps on upper 1-2 inches of palm of right hand and 3-4 inches of right.  10/22/05 and 10/23/05:  The whelps continued to spread up right forearm from palm of right hand to 6 inches below armpit. No pain or itching.  Patient states that most recent whelps burn and are hot.  Patient has used rubbing alcohol topically but denies any meds just for pain.  Patient denies any new medications, foods, contact with plants or recent yardwork.  Patient has approximate 10 year history of flu vaccination without problems.  RN encouraged patient to see PMD and to use Benadryl and cool compresses for relief at present time. NOTE:  RN followed up with patient on 10/28/05.  Patient stated he saw MD on 10/25/05.  Initial diagnosis from MD was allergic reaction?  After conferring with 2nd MD, the first MD changed diagnosis to ?shingles?  Patient was prescribed Famvir, Benadryl, and Caldyphen.  patient was instructed to return 11/01/05 if no relief with meds.  Patient stated as of 10/28, no symptom relief.
4-year-old child given an initial dose of Moderna <5 on 7/21/2022. Returned on 8/26/2022 for the 2nd dose but received <5 Pfizer instead.
about 12 hours after I received the Janssen Covid Vaccine I woke up and had a really bad fever. I was nauseas, was drenched in sweat, and couldn't stop shaking. I went to the bathroom and began violently puking for 30 minutes and then I continued to shake continuously for 3 hours. I was also in a lot of pain and couldn't sleep.
Her symptoms first began last Wednesday 2/8/23  when she noticed she was more fatigued than usual. She had a routine appointment with her PCP on Friday 2/10/23  where they found no abnormalities. On Saturday morning 2/11/23 , she developed chills and severe fatigue which gradually worsened up until 2/13/23. She also reports that she was weak and felt too tired to ambulate. 2/10/23  she had a fever at home of 101.8 F. She denies any diarrhea, nausea, vomiting, chest, or abdominal pain. She is currently on her menstrual period but reports no heavy bleeding and does not use tampons. She has not had much of an appetite, but her mom reports that she has been taking in liquids.   On arrival to the ED on 2/13/23  triage nurses were unable to get reliable pulse ox or blood pressure, and she was tachycardic to the 160s and tachypneic to the 40s-50s. She had good mentation but was uncomfortable in bed and had mild orthopnea. After multiple attempts, IV access was obtained and she was given 2L fluid bolus, which improved her HR. CXR showed no abnormalities. Echocardiogram showed mild pericardial effusion and hyperdynamic circulation. ABG was significant for lactic acidosis, so she was started on vanc and ceftriaxone.  Today 2/18/23, patient remains in the pediatric ICU on the ventilator. No etiology of her septic shock has yet been discovered.
Real, real bad headache. That lasted all day long. I took Tylenol - it would leave for a couple hours and come right back. It went on for a few days and then I went into the doctor and then it lasted for a good couple of weeks.
to the point a pass out; its effect my seizures condition; its effect my seizures condition; I have been sick for months sick with the COVID symptoms; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported) (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. Medical history included seizures. She had been taking mass medications but then not now because it doesn't help her. She was not currently on medication for her seizures. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on unknown date for Covid-19 immunization. The patient got the Pfizer COVID-19 Vaccine, her second dose was on 13May2021 and she had been having the adverse side effects to this vaccine. Since 14May2021, she had been sick with COVID symptoms since she got her second shot and they have not gone away, she had been sick for months to the point a pass out or its effect her seizures condition (medical history). She went to ER, they don't do anything for her. As treatment, she used Nyquil 30ml, she used day time codeine fluid (Further clarification unknown), she had used Benadryl 25mg. She just went up today (04Nov2021) and got the COVID test straight on her that the influenster the all the test and they all come back negative and also the strep test is also coded. Lab data results was confirmed as negative, reported as it's been negative for months. Events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls.  Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up.  Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground.  He needed assistance to get up and family asked him to come to emergency room for evaluation.  He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds.  He is not nauseated or short of breath and has no cough.  He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care.  He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks.  I believe he is on Eliquis now.  In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin.  Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.
1APR: received vax; APR2 & APR3: fever, malaise, h/a, resolved; 13APR: chest pain, SOB intermit; 14APR to ER w/persistent c/o's; dx: pericarditis; question of relationship to previous MMR vax; by 17APR94 sxs resolved;
Pt is 36 yo female, s/p full Moderna COVID vaccination: dose 1 on 1/11 and dose 2 on 2/19. Pt is an employee at this institution. On 8/5, reports new onset of loss of taste/smell and congestion/runny nose. Denies known exposure to COVID. COVID rapid test results positive on 8/5. Pt declined casirivimab/imdevimab infusion.
pt recv vax 15OCT95 & 25AUG96 pt was taken to ER & adm to hosp for several days w/pneumococcal septicemia;pt recovered & @ time of report was doing fine;
approx 29 days p/vax exp chickenpox w/over 100 lesions.
On August 23, exactly 2 weeks after my first dose,  I felt slight cramp in my heart continuously through the day for one to two days.  I also felt light upper chest pain along as well.  The discomfort was minor and did not affect my daily routine.  I never had this kind of cramp and pain before so I knew it was from the vaccine.  I was back to normal after one to two days.  I never    Then on early AM of 9/5/21 while trying to fall asleep,  I suffered heartache that lasted a while, probably several minutes (I did not check the clock to see how long it lasted).  I never had this problem.  I thought that I was going to have a heart attack.   Fortunately, it went away and I was able to sleep later.   I felt tired and weak all day on 9/5/21.  I felt better the next day and is fine so far.
Start suffering from full-body rashes 4 days after got first dose of Pfizer COVID vaccine.  Feel itchy occasionally during a day.  Skin bump (like bite by mosquitoes ) on some body areas and the area changed along the day.
Mild fever, body aches, sore joints, tiredness, nausea, chills. Lasted from 12:00am on 06/19/2013 through 06/20/2013. Aspirin (one 500mg tablet) was taken every 4 hours and it relieved almost all symptoms.
have the Shingrix vaccines and still continue to get it/Suspected vaccination failure; still continue to get it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (get shingles when he/she was stressed).   On an unknown date, the patient received Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingrix vaccines and still continues to get shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming for shingles were unknown at the time of reporting.
This spontaneous report as received from a healthcare worker refers to a 17 years old male patient. On 15-MAR-1996 the patient was vaccinated with the first dose of RECOMBIVAX HB. On 07-MAY-1996 and 04-NOV-1996 the patient was vaccinated with the second and third dose of RECOMBIVAX HB, respectively. Concomitant therapies included ADVAIR and albuterol. On 15-AUG-2013 the patient had titers drawn which resulted negative. It was unknown if the patient sought medical attention. There was no treatment given to patient. At time of report, the status of patient was unknown. Additional information has been requested.
Two weeks after flu vaccine given, complained of left side facial droop. Diagnosed as Bell's Palsy by ER physician. Prednisone 60mg po q d for 5 days ordered, then 40mg for 2days, then 30mg for 2 days, then 20mg for 2 days, then 10mg for 2 days and then 5mg for 2 days. Referred to a neurologist. Also given Acyclovir 400mg po bid for 7days and Ibuprofen. 12/06/04, somewhat improved.
joint aches; tachycardia; chills; headache; nausea; lightheadedness; received BNT162B2, 1st dose and 2nd dose both in Jan2021 (before 07Jan2021); This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose and 2nd dose both in Jan2021 (before 07Jan2021) via an unspecified route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint aches, tachycardia, chills, headache, nausea, lightheadedness on an unspecified date of Jan2021. It was unknown if treatment received for events. The outcome of events was unknown. This case was reported as non-serious.  Information on the lot/batch number has been requested.
Hot & cold, body aches, wrists hurt, headache, itchy rash all over my body
pt recvd vax & 15-20 mins p/, c/o itching & rash; noted fine macular hive like rash on arms & legs;resp non labored;1025am no changes;cont to c/o itching,given DPH;pt c/o tiredness; hives & itching resolved w/o difficulty;DPH if hives retur
Information has been received from a nurse practitioner concerning a patient's nephew, a 17 year old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested.
The area around my mouth began to burn and itch. My eyes began burning. Then my face from the bridge of my nose into my neck became red and itchy. I took BENADRYL which helped but the burning and itching keeps coming back.
severe pain L deltoid radiating into rest of arm, pain below collarbone on right (occured within 45 minutes). 12 hours later I had chills, shivering, severe headache, weakness, generalized pain in muscles.
Extreme tired, aching and pain, headache and sinus but not as bad as when I had covid.