chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in ears - same side asinjection.; Swelling mouth; Swelling throat; Swelling around eyes; Eye irritation; Canchre sores; Mouth irritation; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic, allergic to cats, rabits and seasonal allergies. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination were not reported. On 14Apr2021 at 02:30, the patient experienced ringing in ears-same side as injection, swelling mouth and throat and around eyes, eye irritation, canchre sores and mouth irritation. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not 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 ringing in ears, swelling mouth, swelling throat, swelling around eyes, eye irritation, canchre sores and mouth irritation was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-201, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), SYRINGE ISSUE (non-serious), outcome "unknown" and all described as "the person who administered it didn't give her the full dose of the vaccine since it leaked out of the syringe and came out of her arm". Additional information: Patient got her 1st dose of the Pfizer Covid Vaccine yesterday and stated that the person who administered it didn't give her the full dose of the vaccine since it leaked out of the syringe and came out of her arm. She thinks that she only received about 50% or 3/4 of the dose and wants to know how much is the percentage of protection that the vaccine will give her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I asked patient if she had experience any symptoms to previous Moderna vaccine. Patient stated, "I got hives and my arm got swollen days later after getting the vaccine." I asked the patient did you go to the hospital or receive epinephrine due to not being able to breath. Patient stated, "no." I told the patient I was going to verify with another nurse about the vaccine. I then administered the vaccine on the patient's left arm. Patient was fine after getting the vaccine she went to sit down with her husband. Then patient stated that she couldn't breath and was coughing. I then administered a standard epi-pen on the patient's right thigh. The patient did have a rash on her chest. Vital signs were stable throughout the event, patient was talking, and wasn't cyanotic. EMS came to evaluate the patient. Patient stated, " I feel fine." Patient was given water and refused to be transferred to EMS. Patient was then advised to follow up with her doctor.
I developed soreness and a lump at the injection site about 24 hours afterwards. About 40 hours after I received the vaccine I noticed the right side of my neck just above the collarbone was sore and tight. When I rubbed the area I noticed a marble sized lump on the side of my neck that is tender to the touch.
arm soreness; chills; tiredness; This is a spontaneous report from a Pfizer-sponsored program CoVAX US Support (Medical information team) from a contactable male consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on 14Feb2021 as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included lisinopril 10mg, atorvastatin, montelukast 10mg, omperazole 40mg, tamsulosin 0.4mg, trazadone 50mg and acetylsalicylic acid (ASPIRIN LOW, Bayer). On an unknown date, patient experienced arm soreness, chills and tiredness. He states that he did read that these were common symptoms on the fact sheet and would like to know if he can continue taking his daily prescribed medications (trazadone 50mg, lisinopril 10mg, tamsulosin 0.4mg, bayer low dose aspirin, atorvastatin, montelukast 10mg, omperazole 40mg) after receiving the first dose of the Pfizer COVID-19 vaccine yesterday. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL9266), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medication(s) included: LIALDA; PREMPRO; PREMARIN; TYLENOL; TURMERIC [CURCUMA LONGA]; CALCIUM; CENTRUM MULTIGUMMIES; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; FISH OIL; MESALAMINE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks included collagen. COVID 19 treatment included, paxlovid for 5 days from 30May2022 to 04Jun2022.
6-4-12 to clinic with (Rt) thigh swelling. No erythema defined. Child reported pain since 5-31-12. Mom reports warm to touch yesterday. Today it is not. Child afebrile without limp, ran to get sticker.
Fainted twice and couldn?t maintain consciousness.  I woke to urinate and went from feeling a little ill to burning up and unable to move off the ground or move my limbs. I became nauseous and dizzy.  I fainted on the bathroom floor and again a little while later when I tried to crawl to my purse for the thermometer.  After I laid on the floor for a while, I regained enough energy and to make it back to the bathroom with an intense urge to defecate. (I almost pooped my pants while passed out.)  But, it wasn?t diarrhea consistency   It was blackish, but normal consistency.  At some point I took 2 Tylenol and fell asleep in the floor. By 2:30am, I was feeling strong enough to climb back into bed. I felt like I was dying but then it was over pretty quickly and I was back to feeling normal flu symptoms; 102 fever, body aches, etc.
1/5 I woke up with really bad stomach pain and a severe headache.  The stomach issues lasted about 5 days and the headache 6 so I went the Urgent Care and was given a COVID test which was negative .  On  Wed I woke up with a temp  of 102  but it resolved that same day
1 day after vaccine arm was red around entire tricep area. Patient also developed blistering rash that was still present on 4/12/11. Described as itchy and not painful. Located on both legs and some on arm. Described as round spots. This occurred 2-3 days after vaccine. Patient instructed to also call Dr. Dr. instructed to apply hydrocortisone and BENADRYL by mouth. 4/13/11 - Rash improving.
Child received varicella immunization.  Then approx 15 min later, mom brought him back to with flushed red face, redness and small raised areas over whole body.  Given Benedryl and child sent to ER accompanied pe nurse.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (second shot hurt a little more/patients arm hurt for 2-3 days afterwards), INSOMNIA (difficulty sleeping/difficulty staying asleep) and THERAPEUTIC RESPONSE UNEXPECTED ( the patient is happy because he thinks that the vaccine may have helped his chronic fatigue.  the patient is happy because he thinks that the vaccine may have helped his chronic fatigue. ) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 016B21A) for COVID-19 vaccination. Concurrent medical conditions included Chronic fatigue and Nerve pain. Concomitant products included VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN 81), BACLOFEN, FOLIC ACID, GABAPENTIN, CLONAZEPAM, IBUPROFEN, VORTIOXETINE HYDROBROMIDE (TRINTELLIX), OMEPRAZOLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (second shot hurt a little more/patients arm hurt for 2-3 days afterwards), INSOMNIA (difficulty sleeping/difficulty staying asleep) and THERAPEUTIC RESPONSE UNEXPECTED ( the patient is happy because he thinks that the vaccine may have helped his chronic fatigue.  the patient is happy because he thinks that the vaccine may have helped his chronic fatigue. ). At the time of the report, VACCINATION SITE PAIN (second shot hurt a little more/patients arm hurt for 2-3 days afterwards), INSOMNIA (difficulty sleeping/difficulty staying asleep) and THERAPEUTIC RESPONSE UNEXPECTED ( the patient is happy because he thinks that the vaccine may have helped his chronic fatigue.  the patient is happy because he thinks that the vaccine may have helped his chronic fatigue. ) outcome was unknown. Not Provided. No treatment was provided by the reporter. This case was linked to MOD-2021-106849 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: arm is red and swelled. redness running down her arm and continuing to extend to larger area
I got my shot on the 19. on the 23 i got swollen 2 little hives in the right side bottom of my tongue. Today 24. I felt difficult on breathing and bother me when i eat. I got some more in the top of my throath closser to my throat area.
Yesterday, patient noticed his arm had a raised area at the vaccination site "about the size of a fist and about the size of two fingers width going down to elbow." It does not itch but it is very warm to the touch.
9/12/18 Pt called this am with C/O Lt shoulder (top to elbow) very painful/swollen mild heat no redness. Advised ice 20min on 2-3x this site - watch for headache/fatigue call PCP or ER over week. Will ck on her Monday.
PE had a seizure like episode and stopped breathing per mom. Pt was admitted to hospital for observation.
Sore arm Burning in chest Lymph nodes in the arm pit of the left left arm. It hurt to put my arm down for two days. Still feeling it, but seems to be letting up.  Headache, ongoing. I have woken up with eyes hurting , low grade fever, not consistent.  Joint pain, especially in my hands Ongoing fatigue Swelling fingers and hands Itching has started 5 days later from my shoulders up, including neck, chest, head, shoulders. Still experiencing fatigue, but seems to be easing the last two days. The first 4 days was incredibly hard. This cannot be a ?normal? response. I did not experience this with the first two.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L015460, expiration date 20-JUL-2017 (dose, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Feverish.; Felt Crummy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of fever in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero and Menveo. On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced fever (Verbatim: Feverish.) and feeling abnormal (Verbatim: Felt Crummy). The outcome of the fever and feeling abnormal were unknown.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the fever and feeling abnormal to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-MAY-2023 The nurse at the Health Department, indicated they use Menveo and Bexsero. They used to administer both doses on them same day, however, they had since stopped doing that because they had a few/ handful of patients whose parents called back to report that their child (the patient) had experienced "feeling crummy". Sales Representative asked nurse to elaborate on feeling crummy and asked about being feverish and she said yes.  No further information was known about the gender or amount of patients. The reporter consented to follow up.
It was discovered after administration that the vial had been in the refrigerator 23 hours post puncture instead of 12 hours. A cast was opened with moderna MOD21-151299 to determine if vaccine was still efficacious. No adverse reactions yet reported by patient.
No adverse reactions reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State.)
Pt reported a pruritic rash over abdomen and back that started soon after 04/09/08 clinic visit and lasted a few days.
Presented self with c/o feeling anxious and complained of injection site discomfort.  B/P 133/72, HR 68, 98.2, O2Sat 98%
Pt. help to floor; supine with feet elevated. O2 applied using facial mask at 15 liters/minute. Pt. given juice to drink. After about 10 minutes, Pt. felt better. Pt. helped to sit up and then to chair. At 6:45pm, Pt. given Zyrtec 1 tab po. Pt. observed until 7:00pm at which time she requested to be released as she felt much better. Pt. dismissed. Pt. was seen the next day (1/30/13) at ER. The following is from the adjusters notes: DOS 1/30/13; Dr of E.R. HX: Clmt C/O rash to upper chest & face after receiving Hep A/B vaccine. She was given Zyrtec prior to arival. C/O mild SOB. Exam: Clmt's BMI: 32.5. She is anxious & in distress. Exam of all systems WNL. DX: Allergic reaction. (Likely IgE mediated reaction considering timing of symptoms). Plan: Clmt given Benadryl, Pepcid and Solu-Medrol and observed for several hrs w/resolution of symptoms. Clmt dischrgd in good condition & asked to F/U w/her PCP. Dr listed other possible considerations: anaphylaxis and anxiety.
Acute onset hives about 40-44 hrs after vaccines, generalized including fever with mild puffiness around eyes/lips no respiratory difficulty. (+) itching, (+) pruritic  x 48 hrs waxing & waning with BENADRYL PO tx. No other Sx's, other wise at exam.
Stated he experienced fever, chills, dizziness that caused him to fall. However patient went to his prescriber and is currently being treated for a UTI with antibiotics. Per patient prescriber felt what he experienced could have been from the UTI not the vaccine
Severe muscle soreness fatigue started around 7:00.  At around 8:30 or 9 I started to get a severe headache and fever.  Symptoms lasted through the night. At 4:00am I had a 100.8 fever and by 8:30am my fever was down to 99.  I took Advil at 4:00am and 9:00am.  Headache was much less severe but lasted throughout the day.  Muscle soreness and fatigue were also mostly gone by 8:30am.
the day after the first vaccine, patient reports he had a lot of back pain radiating to legs - feeling like achey flu feeling.  this has been intermittent since the time of the injection.  he feels achey and has shivers.  he has been having  lightheadedness, feels winded all the time, extreme chronic fatigue every day - feels like he can't get enough sleep.  back/leg muscles are twitching all the time.  can't think straight.  having tinnitus and a growth in his ear.  has also had an increase in body odor.  all of these have been present since the first of his immunization series.
Patient reported cardiac (heart attack like) symptoms. Patient went into the local hospital and reported increased HA enzyme levels. Symptoms were reported by patient by 4 pm (chills, labored breathing, heart attack like symptoms).
PT WAS FEELING A LITTLE TIGHT IN HER CHEST AND MIGHT FEEL A TINGLE ON THE BACK OF HER TONGUR.  PT WAS ASSESSED BY EMS. VITALS WNL AT BASELINE. PT WAS GIVEN WATER TO DRINK AND MONITORED FOR 15 MINUTES BY EMS.  SYMPTOMS REPORTED CLEAR BY PT. VITALS REASSESSED AND PT GIVEN MEDICAL INFORMATION FOR ANY PROBLEMS THAT MAY ARISE FOLLOWING HER DEPARTURE.
Fatigue, for 24 hours post-vaccination. It resolved on its own without treatment. Breakthrough menstruation and heavy menstruation, in the week following vaccination. I had not had a period for a few months due to Mirena IUD, until after vaccination. This is still happening.
Information has been received from a nurse practitioner concerning a 24 year old patient with a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively, of Gardasil (lot # 653937/0637F).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of Gardasil (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  That same day the patient played volleyball.  She reported that she did not sleep well that evening.  On 13-Feb-2008, the patient developed pain in her left arm and shoulder.  She reported that her neck and upper back also hurt and were stiff.  She reported that she experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and ibuprofen.  At the time of this report the patient's symptoms have resolved except for the slight hardness at the injection site.  Unspecified medical attention was sought.  No further information is available.  Additional information has been requested. This is in  follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow-up information have been received from a nurse practitioner concerning a 24 year old patient with no known drug allergies and a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively of GARDASIL (lot # 653937/0637P).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of GARDASIL (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  Later that same day in the evening, the patient played volleyball.  She later reported that she did not sleep well that evening.  On 13-Feb-2008, the patient was seen in the physician office.  She reported that on 11-Feb-2008 at 2:18 pm she had developed pain in her left arm and shoulder, that her neck and upper back also hurt and were stiff.  She reported that she had experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and IBUPROFEN.  The patient denied shortness of breath, tightness in throat or rash.  It was reported that the patient stated that she had eating breakfaskt that morning.  It was also reported that the patient denied any injury with volleyball activitiy.  At the time of this report the patient's symptoms have resolved (dates of recovery NOS) except for the slight hardness at the injection site.  No further information available.