chrisvoncsefalvay/vaers-outcomes huggingface dataset:
irritability fever 100.1; irritability fever 100.1; Pfizer: 31Oct2022/Flu shot: 31Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 14 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Oct2022 as dose 3, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing); "rhizotomy shunt" (unspecified if ongoing); "spinal fusion" (unspecified if ongoing); "bilateral hip surgery" (unspecified if ongoing). Concomitant medication(s) included: IRON. Past drug history included: Vancomycin, reaction(s): "known allergies: Vancomycin". Vaccination history included: BNT162b2 (Dose 1, Lot number FC3182, Vaccine location: Left arm), administration date: 14Sep2021, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot number FF2588, Vaccine location: Left arm), administration date: 04Sep2021, for COVID-19 immunization, reaction(s): "14Sep2021: Dose Number: 1/04Sep2021: Dose Number: 2". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 31Oct2022, outcome "unknown", described as "Pfizer: 31Oct2022/Flu shot: 31Oct2022"; PYREXIA (non-serious), IRRITABILITY (non-serious) all with onset 31Oct2022 at 12:00, outcome "not recovered" and all described as "irritability fever 100.1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, irritability.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201270012 same patient/product, different dose/event;
Information has been received on 13Aug04 from a RN concerning a pt who last week was vaccinated with pneumococcal 23v polysaccharide vaccine (lot647038/0926N). It was reported that the pt came back in this week because injection site was sore. The pt also developed swelling and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01759 and 0408USA01761).  Additional information has been requested.
Woke up 2 days later with very sore muscles, fatigue, sore arm. No headache, sore throat, fever or GI symptoms.
Tingling and numbness in injection arm down to first and second fingertips. Occurred for 3 months occasionally and intensity weakened.  Detoxed with clay, exercise, visited workman's comp dr. for testing and treatment. Nerve test was given 1/27/17 with negative result findings of damage.
Pt had reaction (local swelling and erythema) about 6 hours after receiving the flu shot and pneumovax over the left arm. Left arm had indurated, warm, erythematous plaque 17 X 15.5 cm texas shaped rash.  Feeling ok now with minimal pain. She is monitoring the redness as well. No loss of function either. Patient given diphenhydramine prn for itching, swelling and pain.
This is a spontaneous report from a non-clinical-study-program, from a contactable consumer who reported for herself. An 83-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single dose in the arm, in Nov2014. The patient medical history and concomitant medications were not reported. Clinical course was as follows: patient reported that in Nov2014 she had a shot of PREVNAR 13 vaccine in her arm and her arm hurt and it was sore in the muscle area from shoulder down to her elbow. She mentioned that especially when she wanted to lift it up it was very sore in the muscle area up to her shoulder. Patient reported that since the injection, it was very sore in the muscle and it was hard to lift her arm. She also mentioned that it was very painful during night in Nov2014. She did not have any rash or redness in the area. According to the patient, the injection apparently hit a nerve and caused the arm pain which lasted for a couple of days. She had gone to a doctor and that was what he thought that had happened. Outcome of events was recovered on unspecified date in Nov2014. Follow-up (01Dec2014): New information reported from the same contactable consumer includes: reaction details, recovery date and outcome. Follow-up (12Jan2015): New information reported from the same contactable consumer includes: reaction data (event injection hit a nerve was added), doctor opinion.
White patchy and cracked tongue, sore inside lips and side of tongue, small mouth ulcers, rash under arms, sore in back of mouth, discolored on roof of mouth with red sore.
Patient was hospitalized within 4 days of getting the vaccine and passed away 6 days after getting the vaccine
PT DID FINE IMMEDIATELY, ATER VACCINE WITHIN A FEW MINUTES HE PASSED OUT, FELL OUT OF HIS CHAIR AND STARTED SEIZING. I RUSHED OUT OF THE PHARMACY PUT A SOFT PAD UNDER HIS HEAD AND PREVENTED HIM FROM HITTING IT ON THE FLOOR. I TOLD A CUSTOMER TO CALL 911, SHOTRLY AFTER PATIENT WOKE UP AND ASKED US TO CALL HIS PARENTS. ANOTHER CUSTOMER DID THAT AND THEN THE EMS ARRIVED. THEY CHECKED ALL HIS VITALS WHICH WERE WITHIN NORMAL LIMITS AND HE CHOSE TO NOT GO WITH THEM. HIS SISTER PICKED HIM UP TO GO HOME. PT STATED HE HAD NOT EATEN THAT DAY AND HAD TAKEN IBUPROFEN BEFORE ARRIVING.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3302), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FC3180), in left arm for covid-19 immunisation.  The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: Known allergies to Sulfa drugs. Concomitant medication(s) included: CALCIUM; ESCITALOPRAM, start date: 01Aug2021; ESTRADIOL vaginal, start date: 30Mar2022; FAMOTIDINE, start date: 01Jan2022; IRON, start date: 01Dec2021; VITAMIN K2 + D3 [COLECALCIFEROL;MENAQUINONE], start date: 01Nov2022. Past drug history included: Diflucan, reaction(s): "Known allergies: Diflucan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Dec2022) Negative, notes: antigen test 2 days after completing Paxlovid medication; SARS-CoV-2 test positive: (Dec2022) Positive, notes: antigen test 2 and 3 days after negative test (4 and 5 days after completing Paxlovid medication). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Course of events. Patient received treatment with Paxlovid in Dec2022 for COVID-19 infection. Restart of mild symptoms after being fully asymptomatic upon completion of medication course.
excruciating pain in her arm; can't lift or rotate her arm more than 5 degrees; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 (lot number: EM9810) as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) for COVID-19 immunization. On 17Feb2021 17:00, the patient started to feel the symptoms. The patient had an excruciating pain in her arm and can't lift or rotate her arm more than 5 degrees. Therapeutic measures were taken as a result of the events which included treatment with Advil and ice. The outcome of the events was unknown.
fatigue; fever up to 103 F;  left axillary lymph nodes were very sore and swollen for 5 days
After feeling well and dinner I passed out. I came to after a minute or so. Everything was spinning and I was sweating profusely and had pretty strong chills and shivering. I stood on the floor until I felt better. I was able to go upstairs and I went to bed. I did continue to shiver for about 15 minutes. I have felt ok since then. I am not sure if I will get the second dose after that experience.
brachycardia; Fatigue; rush through back of head that turned into headache; dizzy/lightheaded/feeling faint; This is a spontaneous report from a contactable consumer (reported for herself). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection), via an unspecified route of administration on 02Apr2021 12:15 (Batch/Lot Number: EP7533) as SINGLE DOSE, for covid-19 immunisation. Medical history included Asthma, factor v Leiden, heart pfo/ stroke 2003 surgically closed 2004 and known allergies was due to Penicillin. Concomitant medications included mometasone furoate (ASMANEX HFA); azelastine; triamcinolone acetonide (NASACORT); acetylsalicylic acid (ECOTRIN); calcium citrate, colecalciferol (CALCIUM CITRATE + D3) all were taken for an unspecified indication. The patient previously took Bactrim and, nystatin suspension and experienced allergies. It was reported that on 02Apr2021 12:15, within minutes of the injection patient got a it rush through back of head that turned into headache that lasted 5 days, immediately got dizzy and lightheaded, which lasted 3 days and ended up in ER (Emergency room) with brachycardia and feeling faint fit 2 days. Fatigue still ongoing, day 6. Patient was hospitalized from an unknown date in APR2021 for 2 days. Patient received treatment for AE as IV fluids, heart monitoring. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Apr2021. Outcome of the events was recovering.
The pt experienced swelling at site and from elbow to shoulder on side opposite injection site. The pt had a fevered red hot elbow and forearm. Does not hurt. Injection site not sore.
Pt. states that after receiving the 2nd dose of Phizer 08/25/2021, started experiencing symptoms 08/26/2021 of RA flare up. No noted Primary visit. Still continuing to experience symptoms.
patient received third dose of GARDASIL 9 series at a shorter interval than recommended (2 months after second dose).; no adverse effects reported; This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided) and subsequently, on an unknown date (reported as "2 months after second dose") , the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). No adverse effects reported.
1 of 2 pts vaxed on 15OCT93 had an adverse event; pt exp itching, redness from elbow to inject site, swelling & pain; react progressed & required bedrest; 19OCT pt improving;
Presents to the ED arriving by EMS with hx of  c/o SOB onset 0100 this morning. EMS states sats at 72% on RA.Placed on CPAP.  had vomiting.  She developed coughing spells and shortness of breath.  Her symptoms gradually worsened and EMS was called.  Patient has been started on treatment for COVID-19 due to underlying disease conditions such as SLE on immunosuppression.  Continue oxygen supplementation and wean as tolerated.  Weaned down to 6 L of oxygen via nasal cannula.  Patient is fully vaccinated against COVID and also had a booster dose apparently.
Client received first dose of Vaccine, complained of dizziness and experienced a Syncope episode.
Patient received Boostrix and Kinrix; 5 y/o patient received Boostrix; 5 y/o patient received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   On 8th December 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix. On 8th December 2021, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix, the patient experienced overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical assistant reported that the patient inadvertently received Boostrix while also receiving Kinrix, which led to overdose, inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow-up.
I had a migraine headache and uncontrolled vomiting for 4 days. I was confused and forgot words for the next six months. I could not remember any nouns. I took over the counter meds and stayed Hydrated and rested. I talked to a nurse. This also happened on the first dose, but I did not have confusion. I am still confused and do not have a lot of verbal ability. I feel my brain took a big hit from the vaccine in ways that I may not be able to explain.
Left deltoid, 3" redness, 2" swelling, feels hot at sit of Td vaccination
rapid heart rate, dry mouth and metallic taste, throat pressure -- immediate onset, increased in few hours and decreased next day but still symtoms still present
Had the shot at 1 pm and by 9 pm, I started feeling nauseous and achy . Then around midnight I spiked a 102.8 fever. And all night I had extreme chills, stomach ache, headache and diarrhea.  These symptoms lasted about 24 hours. I called the nurse hotline because I felt so bad.
Swelling to glands in right neck, right ear canal swollen.  Pain and headache.
Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 30th December 2022, the patient received the 1st dose of Engerix B pediatric. On 30th December 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 02-JAN-2023 and 03-JAN-2023 Reporter's Comments: Pharmacist reported pediatric Engerix-B was administered to an adult over 20 years old for a 1st shot, they were given the pediatric dose instead of adult dose. The following inquiry came in via voicemail during non-business hours. No lot or expiration date available. The reporter consented to follow up. Additional Supportive Information: The pediatric Engerix-B was administered to an adult instead of adult dose, which led to underdose and adult use of a child product.
pt recv vax 16OCT96 & devel a low grade temp of 99.5;18OCT96 pt devel rales in both lobes, a BP of 90/40, periods of apnea lasting 3 to 4 sec & sleepiness alternated w/restlessness;pt died on 19OCT96;reporter states pt health had been
the side effect of body aches last; How high a fever?; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked how long does the side effect of body aches last after a Shringrix vaccination.
Parent called on 07/30/2021 and stated that the Child had a severe headache and she never had headaches and the only thing different this  week was her recieving her Tdap vaccine. So she wanted it reported
Pt. here for 3 shots after I gave Hepatitis A, he said he felt dizzy. His mother and I helped to exam table so he could lay down. No food in last 15 hours. 1 cut H2O this AM. BP 90/60 to 110/70, pulse 45-60. Walked to car.
Redness, on face with rash, rash, raised, red on neck, some itchiness, it would clear up some and come back. She has visible rash at this time.
15 minutes after vaccination, patient started getting short of breath. the SOB lasted 10 minutes then resolved on its own without any medication treatment
no additional AE reported; the vaccine is no good; incorrect product storage; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 08-MAR-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, by oral route, lot # 1707447, expiration date on 20-FEB-2022, for prophylaxis (strength and anatomical location were not reported). The wholesaler stated the shipment was too long in transit as it should had been received within 2 days (no details provided) and the medical assistant did not see the dates on package before it was thrown away. Additionally, it was stated that vaccine was not good and it was given before finding out it was no good. Reporter did not have details of the excursion and did not know the temperature or time frame. There was no previous temperature excursion and the call was not because of a data logger. No additional adverse event (AE) was reported.
I received both the third SARS/Covid-19 Booster shot from Pfizer and a Flu Vaccine Wednesday, November 3, 2021 at approximately 9:30am.  I did not have any immediate adverse reaction during the initial wait time.  Over the next 48 hours, I had strong pain, sensitivity, and swelling in my left arm (where the vaccine was administered), as the clinician mentioned during my visit was to be expected; I had previously experienced that with the second dose, and the fatigue, and those symptoms with my arm have since dissipated.  Separately, I had facial swelling, in particular around my right eye which I accounted for being part of the nature of the course, but the swelling around my eye has not dissipated.  I have flushed my eyes with water numerous times, and used both cold and warm compresses to try to remedy the swelling.  It is noticeably encroaching on my normal eye-opening which is of course a concern.  As of today, Monday, November 8 no change to eye swelling as occurred.
5 cm redness, 4 cm edema, soreness, pain at injection site. OTC Ibuprofen for pain/swelling, ice to affected area.
2 Events: Evening following 2nd injection, I went from having no dental issues to having severe tooth pain on lower left jaw, roughly 4-5 teeth in from back molar.  Swelling began within hours accompanied by intense pain and sensitivity.  By that Sunday evening, swelling had extended up to left eye, over to bottom of ear, and down neck to baseline and half way to center jaw line.  Bruising present.  Throbbing was constant.  Made emergency dental appointment for Monday, but by that Sunday night, I could not stand it any longer and was afraid the swelling would extend to my throat.  Went to ER, who diagnosed an abcess under the tooth root.  Perscribed pain pills and antibiotics.  Saw dentist Monday, who scheduled me for an emergency root canal on Tuesday.  Got root canal on a tooth I never had problems with before, although there certainly could have been an issue brewing but not yet pronounced.  Anyway, he also drained what he called an unbelievable amount of infection fluid (pus) after making an incision in my gum line and basically squeezing my face to get as much out as he could.  Said he never saw anything like it.  And for me to go from 0 to that in a matter of days was incredible.  I thought perhaps it was an immune response?  At the same time that I was experiencing the dental issue, I started to develop a strong dry cough.  I have a light former smokers cough, and have had pneumonia many times, but this cough was different.  Every day it has gotten strongly, but is very much intermittent.  I now go into fits of coughing that last one to two minutes and so strong and to the point where I have either fractured my rib directly beneath my right breast, or something else is going on.  These fits can last minutes, but never result in expulsion of phlegm.  The coughing fits also occur if I take a deeper breath, walk too far, laugh, or talk too long.  Very strange.  I am very fatigued and have been since the onset of the dental issue reported above.    While the dental issue is gone since the absess was drained, the cough is still present, and wakes me up every single night too with coughing fits.  The cough has loosened up a bit.  I would go to the doctor, but I am in the middle of a move from MO to AZ, and just arrived in AZ after a 3 day drive.  So, first off, I am reporting this issue.  And next, I will seek a new doctor in Arizona if this cough continues.