chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given an expired vaccine. No symptoms were noted at the time of the vaccine. Called patient's father as soon as expiration date was noted. Advised vaccine was expired.  MA lead called, the patient's father and advised per the state  after 2 weeks patient can be checked for the immunization of chicken pox and it will be covered by the clinic, not patient. Patient's father stated he is not interested in this and is not interested in repeating the vaccine.
About 24 hours after receiving the first dose of the Moderna Covid19 vaccine, I was shivering, had a severe headache, and a fever of 103 F.  As well, I had extreme soreness in my left arm soon after receiving the vaccine.
Pimples in my neck; itching; sometimes she needed to take left hand to life up right hand; gas pain/Gas/getting  up very early with the gas; pain that ran all the way down into my finger tips from the neck (back of ear, down to right side); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), ACNE (Pimples in my neck), PRURITUS (itching), MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE, PRAVASTATIN, LISINOPRIL, LORATADINE (LORATADIN), LATANOPROST and TIZANIDINE for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas). On an unknown date, the patient experienced ACNE (Pimples in my neck) and PRURITUS (itching). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), ACNE (Pimples in my neck) and PRURITUS (itching) outcome was unknown and MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas) was resolving.            Patient was rubbing alcohol for the pimples in her neck and itching.   This case was linked to MOD-2021-379760.
Redness localized swelling at injection site also c/o pain. Pt also had swelling in axillary region.
12MAR98 noted redness of eyes progressing to conjunctivitis by 14MAR;pain & swelling in both wrists,rt knee, lt great toe, ring finger rt hand onset 13MAR;eval in ER;labs drawn;seen in ER 15MAR for inc pain & swelling to other joints;
Patient received shingles vaccines on Tuesday 9/3/13 site swollen that night and progressively got larger. Complaints of itching.
Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up.  The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had experience some dizzyness, pale skin and sweating within the 15 mintues of monitoring. Nurse took vitals and heart rate was 50, blood pressure was 92/70. After a few minutes and some water patient's vitals went back to normal levels (BP 110/70) and color returned and no more sweating. Nurse had patient wait another 15 minutes and then they were ok to go home.
After second shot I could not walk 3 days after. I'm currently walking with a cane. I was using a walker. I have nerve damage in both legs, the left is the worse.
Patient's caregiver states that pt had already received the flu vaccine 2 weeks prior.  He was given an additional one on this day inadvertently.
Heart rate at 210 for approx. 10-15 mins.  I was driving when event occurred and I had to pull over and wait until heart rate came down.  I have Exercise induced but never had a SVT event without exercise like this.
Patient received FLUZONE QUADRIVALENT instead of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from non-healthcare professional via call center via agency (Reference number- 00804783).  This case involves a 65 years old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered) and (underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and vaccine underdose (latency: same day).  At the time of reporting, no adverse event reported.   It was reported "The caller states that since he turned 65 they have given him the high dose flu vaccine every year because it has more of the antigen and there is not any question that the high dose is better. He states that there was a different pharmacist there that did not administer the high dose flu vaccine to him but they were more than willing to give him a second dose but he wanted to check on getting a second dose first."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
Onset of chills and fever approximately 24 hours after injection.  Temperature went to 100.1.  Fever broke during the night but is still low grade the following morning.  Fatigue and slight headache the following day.
Pt. presented to mass vaccine clinic on 04/02/2021 stating he needed a second dose  but did not have his vaccine card.   Pt. stated his first dose was at the first of March and Pt. allowed to enter and receive his vaccine.  Upon entry into system, it was discovered that his first dose had only been two weeks prior.   Pt. has not had any adverse affects in the last 3 days since receiving the vaccine too soon.
She got her vaccine, got the vaccine in the morning, it was a little painful but by that evening around 8:00 PM it started getting red and itchy.  Now it's red, there is an area about 5" in diameter that is red and itchy, somewhat painful.  She took some Tylenol last night so that she could sleep.  She has not called her doctor about the reaction yet.
Patient c/o throat closing, however no SOB, or difficulty breathing noted.  O2 sat=98% RA, 100% on 2LNC.  Patient did develop a rash to her back.  Patient c/o palpitations.
Post vaccination, patient  was ok but shortly after complained of dizziness and was unable to stand, actually fell on the floor from a sitting  position.  Did not loose consciousness but was weak for about a minute or two before gradually regaining strength.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages and genders. On an unknown date the unknown number of patients were vaccinated with a dose of (Merck) PROQUAD (lot #, expiration date, strength, dose and frequency were not reported) which were improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Fatigue on 1st day after shot & 2nd day after shot I had a sore L arm and swollen L armpit lymph node
Moderate headache that lasted approx 6 hours, fatigue that lasted approx 12 hours.
Chest pain, left arm pain, joints, severe wobbliness in knees. Very tired, most days I take two naps
This case was reported by a physician via sales representative and described the occurrence of personality change in a 24-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medications included Tuberculin (TB skin test). On 23 April 2012 the subject received 2nd dose of HAVRIX (unknown, right arm) and experienced vaccine administered at inappropriate site. On 24 April 2012, the morning day after vaccination with HAVRIX, the subject experienced side effects. She was told the subject was tired, had a decrease in his appetite, he was not social (decreased social interest) and his mother noticed a change in his personality. The subject continues to experience the side effects until the afternoon of 30 April 2012 and the subject seemed to be back to normal. On 30 April 2012, the personality change, tiredness, decreased appetite, and decreased social interest were resolved. The physician via sales representative reported that the events were possibly related to vaccination with HAVRIX. Follow-up information was received on 25 May 2012 via physician who reported the subject had a mild runny nose and cough that started a few days prior to 23 April 2012 (previously 24 April 2012) and thought it was possibly allergies. The TB skin test (0.1ml) was administered intradermally. The HAVRIX vaccine was administered in the upper right arm. The physician noted regarding the administered at inappropriate site on the subject was adequate subcutaneous tissue or muscle. The physician reported the events started 23 April 2012 and resolved on 30 April 2012. The physician considered the events "serious because it occurred and frightened the parents" [clinically significant]. The physician reported "we found other reports of effect on personality (or seemed to be such)".
Within 4 hours of vaccine fever 102 degrees, chills, voice hoarse, incentive spisometry 2500 prevaccine, decreased 1500-on 01/06/04.
C/o nausea and vomiting, itchy eyes, cough, chest pain, body aches, increased heart rate. Went to MC. States she was given TYLENOL and fluids. Was released with a prescription for loratidine.
Pt recv vax on 8/14/98; on same day pt exp pain at vax site
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/19/20 2nd dose 01/06/21 Diagnosed covid positive:09/12/21 Symptom onset:09/11/21 Exposure: Symptoms:
Information has been received from a physician and the mother of a 12 year old female with pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with the first dose of Gardasil (lot #655165/1425F). concomitant therapy included tetanus toxoid. On 28-DEC-2006, the patient experienced a rash at the injection site right after receiving the vaccination. The patient also experienced mild headaches almost immediately. A few days later the patient's headaches became more intense. The patient still experienced intermittent headaches but the severity has not decreased. On 31-DEC-2006, the patient presented to the physician office and complained that she had a headache for four days. The patient was told by the physician to increase the dosage of Motrin. On 01-JAN-2007, the patient presented to the physician office again and stated that she was not better and still had a headache. The physician stated when the patient pressed over her sinus area it seemed tender. The patient was treated with oral antibiotics. The patients headache persisted. Additional information has been requested.
The pt developed a headache, fever and rash in groin area on 02/20. On 02/21, temp 103 deg F., pt developed itchy head, face, neck, thighs and back.
Red rashy areas on right upper arm, chest and back that began to appear on 2/4/2021.  Raised pustules, almost like shingles in appearance.
Information has been received from a female consumer who on 23-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot reported as "1406P".  Concomitant therapy that day in the same arm included influenza virus vaccine (unspecified).  She reported that she became quite ill beginning the day after receiving the shots, on 24-OCT-2005.  The patient's physician confirmed that she experienced a severe reaction to the vaccination.  The patient ended up missing a full week of work and at the time of the report was still feeling the effects.  No further information was provided.  No product quality complaint was involved.  Additional information has been requested.
I was extremely sick already had COVID before. I'm asymptomatic when I took the vaccine, I became sicker than before. My symptoms lasted for about a week. I was hospitalized and given fluids for dehydration cause of sweating and vomiting. I experienced altered mental status, body aches and fever.
Inpatient who rec'd seasonal flu vaccine and diagnosed with Giullain Barre Syndrome. Patient in hospital as of 11/4/2009. Admitted on 10/18/2009. Patient complaints of tingling, numbness of bilateral hands and feet associated lower back paint that gradually worsened over a 3-4 day period. Symptoms progressed over several days to a level where her whole body felt numb and the tingling got worse ans she developed lower back pain. Patient also complaints of nausea and vomiting. Zofran will be given for nausea control 11/19/09 Medical records received for DOS 10/18/09. Final DX: Guillainn-Barre Syndrome, neuro-muscular respiratory failure, pseudomonas tracheobronchitis, fever.  Polyneuropathy with pain syndrome, adjustment disorder with anxiety.  S/P vaccines flu-like illness for 2 days then C/O tingling, numbness in hands and feet, low back pain. Weakness. Quadraparesis. inability to complete ADLs. Ambulatory dysfunction. LE reflexes absent.  Intubation. IVIG tx. Sputum cx +.  CSF protein increased. PEG tube.
it hurts; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated it hurts after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of it hurts (vaccination site pain) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
LOCALIZED WARMTH AND EDEMA. NO OTHER SYMPTOMS. TREATMENT: TYLENOL 500 mg, 1-2 tab by mouth every 6 hours for pain # 36, no refills. MOTRIN 800 mg, 1 tab by mouth for pain or swelling with food or milk #9, No refills.
sore arm, hot and cold flashes followed by low grade temp up to 100.3 F, chills, nausea and weakness x 36 hours
Headache, Arthralgia, Fatigue Narrative: Fatigue, headaches, body aches, helped by Tylenol
pt recvd vax that pm had sz & apnea; to er; exp 3 more sz w/ apnea; t 102;
The date of my second dose, I just had a slight soreness in my arm. The following morning, lasting all day and night, I had body fatigue, a bad headache, slight disorientation at times, and a swollen armpit on the side of the injection.
Information has been received from a licensed practical nurse and physician concerning a 69 year old female with vancomycin allergy, caecal cancer (Jan 1998), non-smoker, alcohol dependence syndrome and caffeine dependence and a history of rash, hysterectomy, mitral valve prolapse with severe mitral regurgitation, subacute bacterial endocarditis x2 (Dec 1998 and 1982) gastrooesophageal reflux disease, peptic ulcer disease, gastric ulcer, benign hepatic cyst, irritable bowel syndrome, diverticulosis, scarlet fever, sleep disorder, nocturnal leg muscle cramps, multiple blood transfusions, generalised anxiety disorder, panic disorder and uterine bleeding who on 18-DEC-2006 at 14:30 was vaccinated IM into the left deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  On 18-DEC-2006 the patient went to the ER because her doctor's office was closed.  The patient experienced injection site rash, welt at injection site, erythema left upper arm, swelling upper arm, warm to the touch, allergic reaction, left deltoid pain, and was unable to move arm.  On 19-DEC-2006 the patient experienced motor vehicle accident and neck pain.  On 02-FEB-2007 the patient experienced osteoporosis.  Subsequently, the patient recovered.  On 19-DEC-2007 the patient was in a head on motor vehicle accident.  She complained of neck pain.  On 20-DEC-2006, she was seen in her physician's office for follow up to her reaction to Pneumovax 23.  On 02-FEB-2007, the patient was diagnosed with osteoporosis by a dexascan.  It was also noted that on 25-JAN-2001 the patient received a first dose of Pneumovax 23.  The patient's treatment plan was as followed: begin prednisone 40 mg po for five days, continue MACROBID 1 tablet BID for 5 days.  The patient was given samples to see if they would help her sleep, continue ECOTRIN 81 mg oral daily, IMMODIUM A-D as directed PRN, FLORA-Q 1 tablet oral daily, temazepam 15 mg oral at bedtime, AMBIEN CR 12.5 mg oral at bedtime PRN, LUNESTA 3 mg oral at bedtime PRN, MELATONIN 1 tablet oral at bedtime PRN, biotin 1 tablet oral TID, vitamin C 500 mg oral at night, glucosamine chondroitin 1 tablet oral BID, folic acid 800 mcg oral every day, TUMS 3 tablets oral at bedtime, vitamins (unspecified) 1 tablet oral at night, amoxicillin 3 grams prior to procedures for endocarditis prophylaxis.  The patient also had a tetanus shot less than five years ago.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9267), on 02Mar2021 as dose 2, single (Lot number: EN6205), on 07Oct2021 as dose 3 (booster), single (Lot number: 30130BA) and on 16Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Adhesive" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug Allergy". 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported event and suspect drug  cannot be excluded.The case will be reviewed further with information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient stated currently has pain that radiates down to hip and is currently receiving pain medication and is in a wheelchair...