chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101.7 started 12 hours after vaccination, with rapid heart rate, chills, headache. @4 hours later started wheezing. has been wheezing now with some bronchospasm x 3 days. Denies shortness of breath or chest pain. Her vital signs are stable wnl except BP is 130/90. treating with albuterol, oral steroids and benadryl.
Roughly 7 to 10 days after injection I presented with raised, red and itchy injection site.   Roughly 13 days after the injection I presented with a tight right calf muscle that felt similar to a constant "charlie horse". It  continued to worsen over the next 5 days until my right foot went numb and cold on Sunday April 4. I called my doctor the next day (Mon April 5) and they got me in that day and I went to the hospital the same day for an ultrasound. The hospital confirmed I had a blood clot in my lower leg.
booster; Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 43 years as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Contracted Covid".  Clinical Course: Optional Information: Covid symptoms include cough, congestion, sore throat and shortness of breath. Symptoms are mild-moderate. Description of Event: Contracted Covid approximately 6 weeks after booster shot of comirnaty.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 25Mar2021 at 08:15 (at the age of 57 years old), as a single dose for COVID-19 immunisation. Medical history included heart condition, anxiety disorder. The patient was allergic to sulfur. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccination. On 25Mar2021 at 13:15, the patient experienced rash or red marks which had broken out on left arm and little on right arm. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the event red rash was not recovered. No follow-up attempts are needed. No further information is expected.
Caller extremely confused and flustered; I am depressed; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A female patient of an unspecified age (reported as 78 without units) received bnt162b2 (Solution for injection) via an unspecified route of administration on 22Jan2021 as dose 1, single for COVID-19 immunisation.  Medical history included arthritis. The patient's concomitant medications were not reported. On an unknown date in 2021, it was reported that the patient was extremely confused and flustered while giving all kinds of dates and states. The patient stated, she took the first one 4 weeks ago. The patient provided Identification number on the white card she was provided at the vaccination site. The patient received the first shot of the Pfizer COVID vaccine on 22Jan2021. The patient was scheduled on 19Feb2021 at 3:12PM. The patient stated they texted her with the gate she was supposed to go in and then asked for her phone number, they told her it was the wrong number, and it was on the card as the right number.  The prompt said sorry we could not help. The patient was concerned that her appointment was cancelled. The patient stated that she was not angry but depressed on an unknown date in 2021 and was going to go take something. On top of everything else, the patient had arthritis and she got it when she moved down. She blamed her husband. Outcome of the events were unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Severe soar throat, fatigue, headache first few days Developed into nasal congestion, chest congestion, severe cough
In the 3 weeks leading up to February 10th, I became progressively more bloated with fluid in my stomach area, with an increasing feeling of fullness.  By the 10th, I felt so full that I had only eaten one meal in two days.  I had also been sleeping upright for days to attempt to clear what I perceived to be a stomach blockage and therefore was quite tired.  I walked in to the ER and the x-ray revealed the blood clot in my portal vein.  The physician immediately had enoxaparin administered to me and I was admitted.  I received another enoxaparin dose the next morning.  I was discharged on Xarelto 15mg twice a day in the afternoon of Feb 11th.  I am continuing on Xarelto as my hematologist runs various tests and I have an EGD on 4/16 due to a possible stomach ulcer.  I was diagnosed with: Mesenteric venous thrombosis Elevated transaminase measurement Fatty liver
PFIZER COVID-19 VACCINE EAU. FIVE MINUTED AFTER HER DOSE WAS ADMINISTERED, PATIENT EXPERIENCED DIZZINESS, LIGHTHEADEDNESS, AND WARMTH. SHE WAS GIVEN A WATER AND ICEPACK AND FELT BETTER AFTER WAITING ABOUT 15 MINUTES. SHE WAITED AROUND 15 MINUTED LONGER AND SYMPTOMS RESOLVED.
Left arm is severly swollen from injection site down towards elbow, physical lump at injection site, muscle/ joint pain, fever and chills.
Headache, Myalgia. Fever. NauseaVomiting, pain at injection site Narrative:
Swelling noted to left Supra-clavicular area, painful and swelling noted,.
LPN administered a dose of the Pfizer Bivalent 12+ to a patient and did not check the BUD date on the box of the vaccine. It was past the BUD of the vaccine and the dose was administered.
urticarial rash arms, ant & post trunk 15-20 mins p/receiving flu vax x 2 days, relieved w/Atarax;
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a consumer on 30-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route, site and dose in series not reported) on 10-Oct-2017. Patient had numerous allergies, specifically Sulfa and has a rare blood disease and throat issues. Concomitant medications was not reported. On an unspecified date, ever since following the vaccination, the patient had been sick not getting better and has a dry throat. On an unknown date, following vaccination patient had upper respiratory and draining, headache, chills, sore throat, wheezing, difficulty in breathing, hard to swallow, earache, and coughing which continues to today. It was reported that patient received the vaccine at her own doctor's office. Lab data and corrective treatment were not reported. The outcome of all the events was reported as not recovered except the event unwell which was not reported. Upon internal review the company decided to consider the case as serious due to Important Medical Events: upper respiratory and draining, difficulty breathing, swallowing difficult, headache, chills, sore throat, wheezing and coughing. List of documents held by sender: none. Sender's Comments: Patient developed upper respiratory tract infection and earache after vaccination. Exact time to onset is not known. More details regarding patient's medical history, event onset details, previous vaccination history, confirmatory diagnosis reports, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Client received initial influenza vaccine on 10-17-2007 at approximately 12 noon.  Client first noticed symptoms at 530am on 10-18-2007 of itching under the L arm, with progression of hives occurring over the trunk, arms and neck.  She was advised to seek immediate treatment/consultation with her physician.  She did call that office, and they will be contacting her. Client did state during the symptom notification phone conversation that she has 2 sisters that cannot tolerate vaccines derived from egg product or that contain "mycins".
This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age. On an unknown date, patients missed a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported) because the only ZOSTAVAX which was available at the clinic looked unusual and could not be used (PQC files, the exact number of patients which were unable to begin ZOSTAVAX therapy on schedule because of product quality issue was not specified). No adverse effects were reported. Additional information is not expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose number unknown, single (Lot number: FJ4989) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST; PRAVASTATIN; LEVOTHYROXINE; OLMESARTAN; HYDROCHLOROTHIAZIDE. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin family". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pericarditis and pericardial effusion with pulmonary effusion, fever, tachycardia and elevated inflammatory markers, knee pain, rash
She has missed her menstrual cycle this month; Has not got period; This is a spontaneous report from a contactable consumer (patient). A 25-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0 or O 173), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 16:45 as 2ND DOSE, SINGLE for covid-19 immunisation (at the age of 25-years). The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient previously took BNT162B2 on 07Apr2021 for Covid-19 Immunization, Vaccine Lot Number: first dose: it says EW then either 0 or O then 162, expiry unknown. Time the Vaccination was Given:16:30. Anatomical Location of Administration of Pfizer vaccine considered as suspect: first dose: thinks right arm. No prior vaccinations within 4 weeks and adverse events following prior vaccinations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. On Apr2021 patient experienced she has missed her menstrual cycle this month, has not got period. Patient has received both the Pfizer Covid vaccine shots is reporting that she has missed her menstrual cycle this month and wants to know if vaccine affects the female cycle. Patient took both doses and by end of Apr2021 both at 16:30 to 16:45, and is calling bc she doesn't know if normal, she has not got period, she is 100% not pregnant, always gets on time, wonder is COVID vaccine has something related. Her period should have come on 01May2021, and she is wondering if the vaccine affects menstrual cycles or female health. The patient did not visited emergency room and physician office. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient wanted Pfizer booster, but received Moderna. Patient reports severe headache day after and metallic taste when drinking water a few days after.
nausea, persistent vomiting, diarrhea began a few hours after Tdap s/s x 4d not gradually resolved, not hospitalized.
This spontaneous report was received from a practitioner nurse, concerning an 8 weeks old patient of an unknown gender. There were no concurrent conditions, medical history and concomitant medications reported. On 06-FEB-2017 (reported as "today"), the patient was vaccinated with a dose of VARIVAX and a dose of M-M-R II (dose, frequency and route not reported; lot # and expiration date were unspecified, for both vaccines), which were outside of the recommendations per these vaccines prescribing information. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 56 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (19Jun2022) Negative; (23Jun2022) Positive; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
FELT ACHEY; INTERMITTENT SHARP PAINS IN CHEST; DULL AND HEAVY FEELING IN CHEST; PULLED A MUSCLE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 23-OCT-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced felt achey. On OCT-2021, the patient experienced intermittent sharp pains in chest. On OCT-2021, the patient experienced dull and heavy feeling in chest. On OCT-2021, the patient experienced pulled a muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt achey, intermittent sharp pains in chest, and dull and heavy feeling in chest, and the outcome of pulled a muscle was not reported. This report was non-serious.
Extreme pain in all extremities  with the highest level being in the right arm the shot was administered. for three days.
body aches, loss of taste, loss of smell, headache, productive cough and nonproductive cough, chills, sinus congestion, nasal congestion, chest congestion, chest tightness, shortness of breath. starting 11/26/21
1/17/97 Given DPT. At that time had achieved toilet training with day and night dryness since 3/96. Just after that began with recurrence of nocturnal enuresis, from 50-90% of nights. This did not remit. 1/21/98 noted by then to also have some daytime wetting and urgency. On this date had MMR. Within a few days began with intermittent B lower extremity paresthesias happening 3-5 x/day and lasting 4 months. Saw neurologist. This eventually resolved but nocturnal enuresis and daytime urgency did not. 1/11/2010 Continues with nocturnal enuresis which began after immunization.
Patient developed papular and papulovesicular rash over body 13 days after chicken pox shot.  Also had fever.  Given Atarax syrup for itching.
Had 2 shots and had a bad case of shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In DEC-2022, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shots and had a bad case of shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2 doses of Shingles vaccine two years ago and experienced a bad case of shingles in december. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
3 days after I received my injection, I had pain in my left arm. I did not have any other symptoms at that time. I never really had any symptoms until about 3 weeks ago. My stomach has been upset. I am not sure if it is related to the vaccine. I have had an upset stomach and I have been throwing up. I was put on omeprazole for my upset stomach. I went to see my doctor about 3 weeks ago when my symptoms started. I never took any tylenol for the soreness on my arm.
Two weeks after the vaccine my arm became infected. It had a large round ring from the shoulder joint to the elbow. It was very warm, inflamed, and sore. At the injection site there was a white blister. t started to spread above my shoulder. It was very painful and I went to the doctor. I was prescribed Augmentin 500mg. The site improved after two days and was better after seven days. My arm is still a little tender where the injection site was.  After the second shot which I got in the other arm and it did not get infected.
Rash on bottom, around anus, raised bumps outside of that, painful and itchy. Started on 11/20 with diarrhea, which resolved within 24 hours, but the rash remained and grew worse on 11/26. At-home cortisone cream wasn't helping, so a doctor visit occurred on 12/1. Doctor determined that it's a bacterial infection, and prescribed antibiotics and an antifungal cream. The rash (and especially the pain and itchy) has already started to improve (on 12/2).
Sunday 1/17 - chills and sweats Monday 1/18-Wednesday 1/20: aches Monday 1/18-Saturday 1/23: fatigue Thursday 1/21- Saturday 1/23:  swollen gland (right armpit (same arm as injection). Pain in right breast.
Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of breath. Fatigue.
In about three days from the first injection I had loud tinnitus 24/7 in both ears. Could not find anything online about it. Considered not getting second injection but one family member had died from the virus. Saw a dioctor for sinus issues and worse tinnitus. He said he had heard others complain about it after the shot. No known treatment. It was getting more difficult to concentrate and focus. Also I had to ask my daughter to repeat  some words when we were in the same room. Went to an audiologist for testing. Qualified for hearing aids. Healthcare provider said patients were complaining of worse tinnitus after shot. Previously I had  occasional low noise tinnitus, off and on for more than ten years from Betaseron injections years ago. I reported to Pfizer directly about 24/7loud tinnitus. Saw my primary doctor to report it and see if he had heard of any treatments. About May 25thmy right ear had a sudden sharp, piercing sound for a few seconds. A day later it seems the tinnitus is now only in the left ear, or the right ear is much more mellow in tone compared to the left ear. Filled out Vsafe report to the CDC.
Vasovagal syncope followed by metallic/bleach taste in mouth; Vasovagal syncope followed by metallic/bleach taste in mouth; This is a spontaneous report from a non-contactable consumer.  A non-pregnant 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 09:45 (Batch/Lot Number: Unknown) as dose 1, single (at the age of 36 years old) for COVID-19 immunisation.  Medical history included allergies: Penicillin and NSAIDs. Concomitant medications included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced vasovagal syncope followed by metallic/bleach taste in mouth on 06Apr2021 10:00. The event required doctor or other healthcare professional office/clinic visit. The patient received no treatment. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.