chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 1805020) for COVID-19 vaccination.     Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.   On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Patient had not reported any symptoms since receiving that dose of the vaccine.
I went to bed early because I was slightly tired more than usual and woke up during the night in full blown chills. I was so cold that I had to put on many layers and blankets because I could not warm up my bones. Consequently, I woke up a few hours later drenched in sweat and with a fever. For the rest of the day, I was nauseated and extremely exhausted. The next day, my body was back to normal.
After the first dose I had flu-like symptoms with out a fever but a week later broke out on my lower lip with a severe herpies lesion on my lower lip.  The pain was so great as to interrupt my sleep at night.  After my second dose 4 weeks later I had an ulcer in my lower colon with significant bleeding and pain.
While bathing pt went into seizures, eyes rolled back & turned purple. Taken to ER, unconscious, was told in ER had quit breathing, put on respirator. In the hosp for 3 days. Shakes sometimes & px. Seemed warm when put in bath.
patient felt dizzy after getting the pfizer covid shot , she mentioned she didn't eat before she comes in, and kept watching her , making sure she is hydrating , patient said she feels much better, and good to go
Onset of symptoms started within 4 days of the vaccine and have progressivly gotten worse, starting with change in vision, light sensitivity, sound sensitivity, a feeling of "brain fog", veins getting darker all over my body, headaches, irritabillity, anxiety, heart palpitations, occasional vertigo (gound felt like it was moving up and down), constant fatigure, a feeling of pressure in head/ears/eyes, a feeling of sinus pressure, tingling of legs and arms, numbness in legs and arms, feet and hands constantly cold, twitching in face/neck/arms/legs associated with loud noises/bright lights, overall feeling of malice, I have noticed I feel far worse at night than I do in the morning. doctors have found nothing wrong with me nor attempted to treat me.
Leg pain. Started in left leg, moved over into right leg as well. Got xray on left knee- nothing came back. Got ultrasound on leg leg- nothing came back. My legs constantly hurting. Mainly behind my knees, side of my knee, and front of knee . My calves and ankles are also hurting. I feel pain, weaknesses, and throbbing. They are very tired. I visit a sports medicine doctor tomorrow.   Also visiting a cardiologist tomorrow. I?ve been having chest pains (which are normal for me prior to vaccine). However, now my heart is feeling like I?m having palpitations. It starts beating faster then normal. I can feel my heart beating now, which I?ve never been able to notice prior. I?m having to catch my breath often, and have to take really deep breaths.  This is the first time I?ve ever experienced these heart issues.  Visits since vaccine- 2 visits to PCP, 2 visits to urgent care, ultra sound, upcoming sports medicine visit, upcoming cardiologist visit
13 Hours after injection C/O headache, pain at injection site. Body aches, joint pain. Presented again on 11/9/17 complaining of continuing symptoms. She did not keep an appointment with a physician later in the day on 11/9/17. Student did not answer phone call follow up.
pt recv vax & exp sudden onset of tic-like head tossing, very pronounced;pt was hosp for 1 day on 5AUG96;CAT scan w/& w/o contrast was negative, & EEG was read as probable nl for age;had recovered as of the date of this report;
This spontaneous report as received from a registered nurse refers to a 19 months old female patient. Medical history and current conditions were not reported. On 18-NOV-2013, the patient was vaccinated with a dose of VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
"Pt w/ complex medical hx including anorexia, hypothyroidism, PEG, gait difficulty, Dysphagia, bed sores, and COVID hypoxia w/ severe hyponatremia in 2/21.  Complete medical hx not available.  Recent illnesses included severe c-diff infection and proteus UTI requiring ICU admission on 6/29.  Transferred to the floor on 6/30.  Now transfered to Hospital post vaccination for ongoing management. Pt developed rash post vaccination (mildly itchy, mostly on trunk) that has lasted >4days.  Pt also had fever and WBC of 20 w/in 24hrs that was attributed to the vaccine.  Partial Medication List: ? ascorbic acid  500 mg G-Tube Daily ? aspirin  81 mg G-Tube Daily ? cetirizine  10 mg G-Tube Daily ? chlorhexidine  15 mL Swish and Spit BID ? fluocinonide   Topical BID ? Lactobacillus acidophilus  1 capsule G-Tube Daily ? levothyroxine  25 mcg G-Tube Daily (0600) ? melatonin  3 mg G-Tube QHS ? multivitamin with folic acid  1 tablet G-Tube Daily ? neomycin-polymyxin-hydrocortisone  3 drop Left Ear QID ? sertraline  50 mg G-Tube Daily ? vancomycin  125 mg Oral BID"
This is a spontaneous report from a physician referring to a 55 year old female who in April of 1999, the pt received her 1st dose of Lymerix and subsequently, she experienced arthralgia in both hands which did not resolve. In May, 1999, the pt received her 2nd dose of Lymerix and subsequently, she experienced arthralgia in both hands which did not resolve. The physician does not believe that the pt's arthralgia was caused by Lymerix. The most recent information, received on 8/19/1999, reports the condition of the pt is ongoing.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-OCT-2012 16:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
PT noted a rash on his L forearm 10 minutes after the shot.   Otherwise totally asymptomatic. Rash was a faint reticular rash that was non-blanching. No hives, SOB, wheezing, throat tightness, dizziness. VS stable and normal. This was either an unrelated event to the vaccine or a mild local non-progressing reaction.
lip started burning; noticed 3 canker sores on my lower inner lip; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 12:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUBOXONE. The following information was reported: ORAL DISCOMFORT (non-serious) with onset 29Jan2022, outcome "not recovered", described as "lip started burning"; APHTHOUS ULCER (non-serious) with onset 29Jan2022, outcome "not recovered", described as "noticed 3 canker sores on my lower inner lip". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oral discomfort, aphthous ulcer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upper arms rash (back of arms not bicep). Slight rash upper back. Forehead small welts. Roof of mouth slightly itchy. Hard headache that started later the day that got progressively worse by the next day. Getting better about 5 days later. Gone in about 9 days.
Sudden sensorineural hearing loss in the right ear.  In the evening on May 8, I suddenly experienced a sense of fullness, partial hearing loss, and tinnitus in the right ear. On May 9, I went to an urgent care clinic and was diagnosed with eustachian tube dysfunction. I was instructed to take pseudoephedrine and a steroid nasal spray and told that it should clear up in a week or two. When my hearing did not return after a couple of weeks, I saw an ENT on May 27 and was diagnosed with conductive hearing loss and put on a course of oral steroids. I sought a second opinion and saw an audiologist on June 10, where I was diagnosed with sensorineural hearing loss. I was given a stronger course of oral steroids, followed by two intratympanic steroid injections. Neither the oral steroids nor the steroid injections have reversed any of my hearing loss, so it appears that I have permanent partial hearing loss and tinnitus in my right ear.
a 12 year old male patient was given Daptacel instead Adacel,No AE; a 12 year old male patient was given Daptacel, No AE; Initial information received on 02-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 year old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 02-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5611BA and expiry date: 03-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong product administered.  At the time of report no adverse event was reported.  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 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.
symptoms: fever (up to 102) chills  headache  dizziness  naesous  body aches   treatment: ibuprofen   outcome:  miserable, couldn?t sleep or eat and the fever wouldn?t break. the ibuprofen made the headache go away
Myalgia, Fever, NauseaVomiting, fatigue, weakness, chills Narrative:
This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine), DEVICE CONNECTION ISSUE (It was because of the syringe) and INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine) and DEVICE CONNECTION ISSUE (It was because of the syringe). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm). On 03-Jun-2021, UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine) and DEVICE CONNECTION ISSUE (It was because of the syringe) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up telephone call response (TCR) received from  pharmacist. Added new event with outcome.
Received second Moderna Covid-19 shot on 1/22 @ 9:40 am. Around 8 pm that evening started feeling chilled and body felt "heavy". Took ibuprofen 400 mg and went to sleep. With the exception of getting up to urinate, slept 36 hours and woke up on 1/24 with no recollection of previous day. In addition there are small blisters around both corners of mouth.
The patient had erythema and tenderness on the right thigh, the size of a baseball. He had firm muscle walking with full range of motion. Not hot mild adverse reaction, no cellulitis. Treat with heat and Motrin, recheck when necessary.
36 hours after receiving 2nd vaccination I started having diarrhea, nausea, vomiting and a swollen tongue.  Symptoms subsided after 12 hours.
Patient states that his arm still hurts from when he received the flu shot on 10/6/15.
DISCHARGE SUMMARY:   MRN:  Name:  Age: 83 y.o. Birthday:   Admit Date: 7/28/2022  2:48 PM Discharge Date:  8/4/2022 Unit:  Admitting Physician:  Discharge Physician:  MD   Discharge Diagnosis: Principal Problem:   Acute metabolic encephalopathy Active Problems:   HTN (hypertension)   Acute cystitis without hematuria   Weakness generalized   COVID-19 virus infection       HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "Patient is a 83 y.o. female with a history of neuropathy with the lot of problems with ambulation presented after a fall earlier today and she could not get up from the floor. Neighbor recommended to come to the emergency room and get evaluated. Denies any blackout. She hit her head somewhere. CT head negative. Confused here. Brother at bedside and helped with some of the history. She was diagnosed with UTI recently and was sent home on Omnicef. Urine culture came back resistant to cephalosporin and patient was started on Cipro yesterday. Not sure what makes symptoms better or worse. Patient denies any dysuria, UTI symptoms, fever, chills, pain or any other concerning symptoms. Admitted for further evaluation."     Hospital Course: Patient is a 83 y.o. female who presented with confusion, weakness.  She was managed for the following:   * Acute metabolic encephalopathy Acute Pulmonary Embolism - likely provoked by active COVID-19 infection.  CT PE study with left lower lobe segmental PE.   BLE US with possible LLE DVT.   Continue po eliquis, will need 6 months anticoagulation.  Follow-up with PCP.    COVID-19 infection - stable, on room air.  Completed remdesivir 5 days.     Acute UTI - completed course of macrobid during admission.     Debility - PT consulted, recommend SNF.  Pt will discharge to HCF for short term placement.     Acute metabolic encephalopathy - delirium due to acute illness with UTI and COVID-19 infection.  Confusion resolved.          Physical Exam on the Date of Discharge: Blood pressure 135/53, pulse (!) 49, temperature 97.8 °F (36.6 °C), temperature source Oral, resp. rate 18, height 5' 2" (157.5 cm), weight 50.5 kg (111 lb 4.8 oz), SpO2 100 %. General - NAD, appears stated age, frail elderly female HEENT - EOMI, PER, MMM, Chest - lungs clear bilaterally Heart - RRR, NS1S2 Abdomen - Soft, non-tender,  Extremities - warm,  Psych - AAOx3, Skin -  dry   Discharge Condition: improved   Disposition: SNF
Slightly swollen, red and hot 2/3 of right area where MMR was given.
Hot, Red, swollen arm 11/01/2006 administered, 11/07/06 presented at office with SX.
At 8pm 11hours after vaccine administration experienced muscle aches all over  At 9pm experienced chills and shivering  At 10pm high fever  The next day felt okay but just tired and sore  At time of report, feeling fine
Neurological symptoms: initially lower extremity weakness & feelings of numbness. Buttocks, legs, and feet felt heavy with tingling, burning, & muscle twitching. Progressed to upper extremities with feelings of weakness, numbness, tingling and muscle twitching. Progressed to near inability to walk on the 6th day. After 9 days, extremities remain weak, with feelings of numbness, tingling and hot sensations.  11/25/09 ED, Hospital records and discharge summary received. Service dates 11/22/09 to 11/23/09. Assessment: Mild quadraparesis of uncertain etiology.  Patient felt jittery a week ago, admitted because of weakness. "Funny feeling" heels bilateral. Difficulty walking. Generalized tingling feeling. C/O back discomfort, weakness or fatigue of lower extremities. Legs feel heavy, numbness. Mild hyper-reflexia. Overweight. Reports subjective improvement and discharged.
Body ache, chills, diarrhea, dry mouth, not appetite, headache, just not feeling well, soreness and body aches, tiredness.
Urticaria began 1 day post vaccine, associated  with nausea, vomiting. Duration of illness 1 week.
Very heavy menstrual period.. have never I'm my life seen a flow that heavy..its disturbing
Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06070, 2012-06071, 2012-06072, 2012-06073. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE SV, sanofi pasteur Inc., lot number UH478AC in dose form multi dose vial (MDV), (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Follow-up information received from a healthcare professional on 15 October 2012. The patient was female and 6 years of age when she received the FLUZONE SV on 23 November 2011 and 117 days post vaccination had a positive PCR test for influenza A/H3. The patient had a positive rapid flu test in the office (date not provided) and the sample was sent to the state lab where it was also positive (date not provided). The patient had no concurrent illnesses, and was not taking any other medications, and had not received any other vaccination within 4 weeks of 23 November 2011. The patient recovered on an unspecified date. Documents held by sender: None.
inconsolable high pitched screaming treatment-Tylenol, ibuprofen (R) thigh sl. swollen and tender
Patient was only given vile 1 of Lyophilized gE Antigen Component to form SHINGRIX.   No symptoms, or adverse outcomes to this. According  to patient must wait 4 weeks after receiving this and then she can begin series.
I developed blepharitis of my left upper eyelid with tenderness and swelling. Symptom onset 8-10 hours afterward, peaked 48 hours later. This  eventually led to 2 chalazions in that eyelid. I have never had one before in my life. I may have been predisposed somehow and the inflammatory response to the vaccine triggered the blepharitis. I looked like cartoon character. The blepharitis was gone within 10 days but despite intervention, the chalazions did not clear up. (I'd prefer to call this a side effect rather than an adverse effect, but I'm filling this out to provide more complete data as I know several people who have had inflammatory problems with the vaccine.)
w/in 2-3hr of vax pt had chills, temp of 100.4, sl h/a, generalized achiness & malaise, lasting about 12hr;
Pain in her arm at the injection site/Arm was so painful; Shoulder was so painful/pain moved from her arm to her neck and shoulder; Can hardly move (arm and shoulder) now; Arm was so painful; Pain moved from her arm to her neck; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can hardly move (arm and shoulder) now), PAIN IN EXTREMITY (Arm was so painful), NECK PAIN (Pain moved from her arm to her neck), VACCINATION SITE PAIN (Pain in her arm at the injection site/Arm was so painful) and ARTHRALGIA (Shoulder was so painful/pain moved from her arm to her neck and shoulder) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A1 and 021B21A1) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can hardly move (arm and shoulder) now), PAIN IN EXTREMITY (Arm was so painful), NECK PAIN (Pain moved from her arm to her neck) and ARTHRALGIA (Shoulder was so painful/pain moved from her arm to her neck and shoulder). On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in her arm at the injection site/Arm was so painful). At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can hardly move (arm and shoulder) now), PAIN IN EXTREMITY (Arm was so painful), NECK PAIN (Pain moved from her arm to her neck), VACCINATION SITE PAIN (Pain in her arm at the injection site/Arm was so painful) and ARTHRALGIA (Shoulder was so painful/pain moved from her arm to her neck and shoulder) outcome was unknown.            No concomitant medications were provided.   Treatment information was not provided.  Patient started experiencing injection site pain within four to five hours post vaccination.