chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm 63 years old with no prior history of heart issues or circulatory problems nor a family history of heart issues. I Received the 2nd mandated Pfizer Covid 19 vaccination (FA1485) from Pharmacy on 08/06/2021. I Started feeling heart palpitations & fluttering during my cardio workouts and road bicycling during mid November 2021.My heart rate monitor, which I use on every bicycle ride was reading 206 BPM... I was constantly struggling to catch my breath. I was in constant fatigue with headaches and always felt nauseated. I initially thought this would be a temporary condition. In May of 2022, i fainted on 2 occasions after a somewhat easy ride & workout. I was able to make an appointment with my General Practitioner June of 2022. Upon my examination, he was shocked that my Resting Heart Rate was 161 BPM and that I was in a condition called AFIB. He immediately sent me to a cardiac specialist for further diagnosis that day. After an initial EKG, The cardiologist agreed I was in AFIB, my HR was still 160+ & my blood pressure was an alarming 180/120. The cardiologist told me I needed immediate cardiac attention. I was sent to the adjacent hospital ER due to this serious medical emergency. I was administered IV drugs to bring the HP & BP down to a manageable level. Since this cardiac episode, I've been hospitalized 3 times, had 2 CardioVersions, shocking my heart into a normal rhythm (unsuccessful) and had an Angiogram to determine if I had a circulatory blockage. I did not. I had a Sonogram taken and it was determined my left heart atrium was 5 centimeters enlarged and Mitral valve problems. I'm currently on 4 different cardiac medications to control electrical activity to my heart, medication to keep my heart rate down, medication to keep my BP in a safe, but still high, range & a blood thinner to keep my blood from clotting, causing a potential stroke, heart attack or any other cardiac related emergency. I'm a very (was) active cyclist and did cardiovascular training daily. My family has no history of genetic heart issues and my doctor conducts a thorough, complete physical with a non problematic EKG annually. He would always tell me that I was in "great shape" for my age and whatever I was doing, keep it up. Up until the past few  months, while data comes forth, I believed that Pfizer, Moderna, J&J vaccines were safe, tested, would keep me safe from Covid spread from unvaccinated persons. Because this "mandated" vaccination was a requirement forced upon my 100 plus employee employer, the only choice I had was to Vaccinate or be terminated... Even after 33 years with the same employer at the same job. I believe the FDA needs to leave no stone, unturned to find out why citizens are developing severe cardiac problems  resulting in short term, long term and even death from cardiac related injury. I'm sure this 'heartfelt' diatribe will fall upon deaf ears, but as a citizen, husband, father, grandfather and taxpayer, I felt it was my duty to tell my story.
11/25/11 fever 103.5 ; rash on face, torso - "small red dots" developed 11/27/11 lasting at 48 hours. 12/3/11 - Rash reappeared face, torso, diaper area no fever.
Patient arrived at clinic with father. Father provided staff with date of birth and documented as such on consent form, which would make her 12 years old and eligible for Pfizer vaccine and was immunized with her first dose by our staff. Admin person who checked them in seems to remember that father said birthdate in system was wrong when questioned about discrepancy. We were contacted by department of health on 7/12/2021 about a birthday discrepancy with patient. System has her birthdate locked in as 2010 due to a birth certificate verifying the 2010 birthdate. Either father was wrong about her birthday or was purposely deceptive in order to get her the vaccine. Father does not answer phone calls nor messages, email was invalid.
Patient states that symptoms of intense arm pain started about 4 hours after receiving the flu shot. The intense pain lasted 1 day, however, the arm is still bothersome in the morning.
Severe headache and nausea started 1 hour after vaccine.  Given ibuprofen. Headache lasted approximately 15 hours.
COVID-19; COVID-19; BRAIN FOG; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4518641-00 (Agency).  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1160830), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Aug2022, outcome "not recovered", described as "BRAIN FOG"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed. Patient was with events of non-serious brain fog and COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date in Aug2022, the patient experienced brain fog. In Aug2022, the patient experienced COVID-19. COVID-19 VACCINE and MODERNA COVID-19 VACCINE (ELASOMERAN) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality details for HUMIRA (ADALIMUMAB) included the reporter's causality for the events of brain fog and COVID-19 was not provided. Ongoing HUMIRA (Solution for injection in Pre-filled pen) (ADALIMUMAB) via subcutaneous route of administration for moderate to severe Hidradenitis Suppurativa. COVID-19 Vaccine (COVID-19 Vaccine) (COVID-19 Vaccine) as single dose as solution for injection for COVID-19 vaccination. Drug causality for drug Humira with the event Foggy feeling in head (Feeling abnormal) was not reported and action taken with drug was dose not changed. Drug causality for drug Humira with the event COVID-19 was not reported with action taken with drug was dose not changed. Drug causality for drug COVID-19 vaccine and MODERNA vaccine with the event Foggy feeling in head (Feeling abnormal) and COVID-19 was possible with the action taken as unknown.   The reporter considered "covid-19" and "brain fog" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to allow appropriate reporting to FDA with the correct Emergency Use Authorization number 027034 for BNT162B2.; Sender's Comments: Based on available information in the case the reported events Covid-19, Drug ineffective and feeling abnormal are assessed as related to suspect drug .
Patient is a 81 y.o with PMH of T2DM, HTN, HLD, BPH, and obesity who presented for dyspnea, and cough found to have COVID pneumonia initially admitted to hospital for AHRF d/t COVID-19. MICU consulted for rapidly progressing respiratory failure requiring high flow oxygen with AMS. Continued to be hypoxic with mild hypercarbia, so started on BIPAP. Discussed GOC with family and patient. They elected to make patient DNR/DNI due to his poor prognosis, advanced age and underlying dementia. Patient's condition continued to deteriorate and he expired on 9/14/2021, approximately 2 weeks after hospital admission.
Pt received a Covid Pfizer vaccine today at pharmacy and is few moments later passed out while sitting in her chair. Paramedics were called and her VS and BG were normal. Pt's mom declined ER visit . Pt went to PCP for F/U and vital signs were normal , EKG was normal. Pt was nervous about receiving the vaccine . Pt has not passed out after vaccination administration previously
sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea, which led to dehydration.
Tingling sensation, arm pain not at injection site but more like muscle pain weeks after the vaccination . I also had it bad on the 2nd dose where a sudden pain on the left lef and left arm will wake me up. I had a one day left groin pain too. Booster caused me tinnitus
Severe Diarrhea from 8:00 pm until about 2:00 am.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During January 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-JUN-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Petechiae on left arm below injection site and on right shoulder blade about 4 hours after injection. Continued petechiae in the same locations, headache, chills and full body aches the next morning (about 12 hours after injection), lasting all day. 1000mg  PO Tylenol taken at 09:30am. All symptoms continued throughout the day.
Systemic: Allergic: Itch (specify: facial area, extremities)-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: patient complained of itchiness on her neck, arm and back a few minutes after getting the shot. RPH on duty gave her two dose. RPH observed her for 30 minutes, to make sure her condition doesn't get worse. She seems to be feeling ok, so we let her leave the pharmacy after 30 minutes. We counselled her to go to the ER if she feels any difficulty breathing or severe allergic reaction of itchiness worsens. RPH followed up with patient 2 hours afterwards and patient itchiness had resolved.
Headache, vomiting, diarrhea, low-grade fever, chills, body ache,  arm pain and itching.
minutes after had flushed feeling all over body (similar to when I had dye injected for a cat scan).. felt lightheaded and extreme dry mouth.. lasted for about an hour. blood pressure when check on floor had a high diastolic number (120/94)
The decedent received the second dose of the COVID vaccine on 7/29/2022.  She began vomiting at bedtime on 8/1/2022 and was found unresponsive the morning of 8/2/2022.  She was transported to the emergency room by EMS where pronounced.
I was beginning to start itching and had hives. I took Benadryl and nothing worked. I also had rapid heart beat. All doses had the same reaction. I had to wear a heart monitor for a week.
The first symptom started later Saturday with numbness to my fingers on my right side.   Then both feet have went numb. The numbness in my right arm stops at my elbow and both legs stop at my knees.   I've also have had headache with no relief from Tylenol.  I also after the right arm numbness started have numbness noted on my face starting at my bottom lip down to my chin.    I have redness or nodule to the injection site.    I was supervisor last night so I went to see PA to see what he had thought before I decide to leave work and check in to the ER.    He recommend taking Benadryl to see if it was a reaction  I did and my symptoms got better   I strongly believe I'm allergic to it and worried a lot if it may be Gullian Barre syndrome.
respiratory and cardiac arrest Narrative:  Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.
Pt awoke To pain concentrated around lymph nodes all along the Right side accompanied by severe fatigue. She presents today saying symptoms are less intense but has not fully resolved
In the ED 3/14/21 Patient states yesterday she got the Johnson & Johnson Covid vaccine.  She says that today she started having fevers chills generalized body aches generalized malaise and headache.  She says she is otherwise healthy denies any sick significant medical history.  She endorses some mild shortness of breath associated as well as some nausea and diarrhea but denies vomiting. IV fluid bolus, acetaminophen and ibuprofen
No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report was received from Other Health Professional and refers to a.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-OCT-2022, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On an unknown date, the patient experienced No additional AE.. On an unknown date in October 2022, the patient experienced administered Improperly Stored M-M-R II lot. At the time of reporting, the outcome of the event administered Improperly Stored M-M-R II lot was not known. The action taken with M-M-R II regarding administered Improperly Stored M-M-R II lot was reported as Not Applicable. The action taken with M-M-R II regarding No additional AE. was reported as Not Applicable.
pt recv vax 12SEP97 lt deltoid;13SEP97 large red area, size of a pancake over inj site;14SEP97 on awakening pt exp swelling & extreme tenderness over the lt jaw joint 15SEP97;s/s began to disappear;
This spontaneous report concerning a female patient of an unknown age was received from a pharmacist. The patient's concurrent condition and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), (lot and expiration date were not provided) subcutaneously. There were no concomitant medications reported. On an unknown date, reported as about three days following the vaccination, the patient experienced a "reddened itchy" area that looked like a rash, however, the reporter stated that it was not a rash, but an injection site reaction that looked like a rash. In addition, it was stated that the patient sought medical attention (reported as "seen at the pharmacy"). No product quality complaint was involved. At the time of reporting, the outcome of infusion site reaction was unknown. The causality between ZOSTAVAX and the event of injection site reaction was not assessed. The reporter did not considered the event of injection site reaction life threatening or medically significant. Additional information has been requested.
2nd dose made me I'll approximately 7 days. While on AM walk experienced temporary "fogging up of Left eye"  Gradually, over 2-3 weeks vision deminished to unable to see.   Eye doctor sent me to another facility, Where Prednisone IVs were rec'd over 5 days followed by extensive testing, artery biopsy, etc. Still,, to date under doctor care/supervision.
Pt recv vax on 4/12/99; on same day pt exp circular rash at vax site, achy; tx=Benadryl
Anaphylactic reaction; 30 mins post inject devel swelling of eyes & face w/resp sx; treated & recovered;
The two times i took flu shots i contracted the flu/ Suspected vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported The patient received flu shot and experienced flu. No other information was reported. The case was linked to case US2020AMR193666, reported by same reporter. This case was considered as suspected vaccination failure as details regarding exact time to onset for target disease and laboratory confirmation were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193666:same reporter
Swelling and redness of entire upper arm, with pain scale 6/10. Spoke to client on day 8 with pain, redness and swelling unresolved.  Advised to seek care at PCP.
Total body rash with severe ankle and feet swelling and peeling  that continues even after getting vaccine more than 3 weeks ago
This spontaneous report was received from a medical assistant via company representative refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiry date were not reported) for prophylaxis. On 14-AUG-2017, the patient was throwing up. Outcome of vomiting was unknown. The reporter did not provide the causality assessment between the event and GARDASIL 9.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse manager. This case involves an unknown age three patients who received vaccine FLUZONE QUADRIVALENT. The patients' past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via nasal route. It was an actual medication error due to inappropriate route of vaccination. It was reported that another nurse in their practice administered the FLUZONE QUADRIVALENT as a mist instead of intramuscular. Caller stated that she has 3 employees that received a FLUZONE QUADRIVALENT as a Flu Mist through their nasal cavity. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Moderate blurry vision / haze; Moderate blurry vision / haze; Eyes feel strained.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) in the left arm on 25Mar2021 at 09:30 (at the age of 43-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) in the left arm on 22Apr2021 at 09:15 (at the age of 43-years-old) as a dose for COVID-19 immunisation. Medical history included left eye cornea injury when patient was 12 or 13, that inhibits focus and gives a haze on left eye only. Right eye has always compensated and given perfect vision and color representation. One of patient's professions is as graphic designer and over past two years patient's close vision has slowly decreased due to age. The patient has known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN); for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced moderate blurry vision/haze which started after first dose. No distance range was in perfect focus, eyes felt strained and it seemed to be getting worse every day. The patient reported that these new issues were not related to his previous medical history of eye cornea injury. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blurry vision/haze and eyes felt strained were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
2nd shingles vaccine. Feel like I got hit by a truck. Muscle aches, headache, nausea, slight shivering but that went away pretty quickly. Sore at the injection site (upper shoulder).
About 10 minutes after I received the injection, I felt dizzy. Prickling sensations and flushing on the backs of my hands and on my face. Racing heartbeat. The symptoms lasted for about 5 minutes, then subsided completely.  Approximately an hour later I felt very tired, and had a mild headache. Took a Tylenol tablet and rested. Felt better after about 2 hours.