chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA315882, 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887 and 2018SA315888 (same reporter). This case involves a 65 years old male patient who received 0.5 ml dose of FLUBLOK QIV lot number QFAA1815, expiry date-30-06-2019 via intramuscular route in the left deltoid on 07-NOV-2018. Concomitant medications included was BOOSTRIX for Immunisation in the right deltoid on the same day. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines were exposed to a maximum temperature of 52 F for 27 hours patient inadvertently received FLUBLOK QUADRIVALENT. It was unknown whether patient experienced any adverse event following vaccination. 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. Documents held by sender: none.
Fever of 100°F onset about 18 hours after injection, body aches, joint pain, chills. Lasted about 8 hours. Started to fell better about 24 hours after injection. Treated with ibuprofen and bed rest.
extremely sore arm down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extremely sore arm down to the elbow) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced MYALGIA (extremely sore arm down to the elbow). At the time of the report, MYALGIA (extremely sore arm down to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-364223 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-364223:patient 1
2-3 days after vaccine, the left side of my body went numb. Went to hospital where they did 4 tests, lumbar injection/MRI/Blood work and Cat Scan, believe to be  transverse myelitis. Neurologist suggested inflammation of cervical spine.
Rash on neck, torso, armpits, back. spots at first than spots merged to make a blotching. Got hot and itchy. used benadryl for itch and cortisone. Itched more at night and lasted for about 6 days.
redness & swelling of thigh, t101, crying 3 1/2 hrs; onset approx-noon; MD office approx 2-3PM;
rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states symptoms occur in afternoon  advised to see PCP
Numbness in my right leg (entire leg) followed by tingling (felt like leg fell asleep) by the end of the day was also in my left leg. Small pinpoint scabs on both thighs the next morning. Scabs have healed however numbness /tingling still occurs in both legs on and off and it has been over 2 weeks.
pt very sore at inj site, edema, pain in all joints, very stiff, can not bend, pain in shoulder, can't lift arm above head, swelling under arm & into breast& down arm, unable to move arm at times.
Information has been received from an office administrator, concerning a some patients of unknown age and gender. On an unspecified date, the patients were vaccinated with a dose of (Merck) PROQUAD (dose and route were not reported) (Lot # and expiration date unknown), that had been exposed to 15F for 13 days. The specific number of patients was unknown. There was no adverse event. Additional information has been requested.
The day I received the shot I had a sore arm.  My arm was sore for a few days. But then the soreness went away.  I woke up one week after my first shot with a large red spot on my arm where the shot was given. It was warm to the touch. It itched as well.  Additionally it was sore under my left arm in my arm pit. The soreness under my arm  lasted 4 days. The redness has gone down 5 days later but is still visible.
Received literature article on 09JAN2017. The article notes a woman potentially exposed to Bacillus anthracis while in another country, and noted to be pregnant at some unknown date, was medically advised to transition from ciprofloxacin to amoxicillin. No adverse event to either BIOTHRAX vaccination or antibiotics was reported. Additional information was received from epidemiologist, one of the co-authors of the article, on 09JAN2017: The reporter indicated that the subject had received prior BIOTHRAX vaccination, but was not up to date per standards. On an unknown date, following potential exposure to B. anthracis, she received 1 dose of BIOTHRAX vaccine as a booster and was prescribed 60 days of antibiotics. After 30 days, for an unknown reason, she was advised to switch drugs from ciprofloxacin to amoxicillin. The subject's date of conception in relation to the timing of events is unknown. No further information is expected.
Reports continuous crying from 830AM to 1230; describes hard deep cry; extremities shaking; crying spontaneously; stopped; infant went to sleep; no other problems;
vestibular neuritis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VESTIBULAR NEURONITIS (vestibular neuritis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR NEURONITIS (vestibular neuritis). At the time of the report, VESTIBULAR NEURONITIS (vestibular neuritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient experienced symptoms two days following the vaccination. The symptoms included vertigo, dizziness, migraines, nausea and insomnia.   Reporter did not allow further contact
pt recvd vax; large local rxn secondary to vax; fever, erythema, swelling of LUE x 72 hrs;
Palpitations, blood pressure elevation (149/`03), headache, nauseous, shaky, pain in back, rapid pulse, trouble sleeping due to rapid pulse and elevated blood pressure. Over 20 years ago I received the live swine flu vaccine, of which I had a horrible reaction to. I ended up with Guillain-Barre Syndrome, but the doctors that I went to did not diagnose it as such. As a matter of fact they didn't know what the problem was, so I suffered all that time and still have reactions but not as often. As a result I refused to get my yearly flu shot - so last year was my first shot since that time. When I went this year (2011) I informed the person who was giving the vaccines of my previous problem and I was reassured that I would be perfectly ok. Well to my surprise after I had the reaction I had I was informed it contained the "swine flu" H1N1 vaccine. This is why I had the reaction to the flu shot.... rapid heart beat, elevated BP, nausea, headache, back pain, trouble sleeping. I had trouble with the rapid heart beat but I finally went to a doctor who finally treated it and I have been on the medication ever since (timolol maleate).
About 4 weeks after first dose, my mother got the covid virus!!!!!! Now, her kidneys are shutting down!!!!!!!
Pt complains of itching/tongue swelling. MD on site assessed pt, advised pt to take 50mg Benadryl. Pt monitored for additional 30 minutes, swelling improved, vitals stable, lung sounds clear. MD released pt to home
Immediately felt tingling down arm and into fingers of injection arm. Within 1 hour, couldn?t lift arm. Continued until 10/9/20 and is now gradually resolving. Was examined by Dr today. Not yet fully recovered.
can't focus; can't remember things; can't work; not had a menstrual cycle in two weeks which they say is not normal; feels like crap; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal) and MYALGIA (feels like crap) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued). At the time of the report, DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.
This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of injection site soreness in an unspecified number of adult and children subjects of unspecified genders who were vaccinated with HAVRIX. In May 2008, The subject received unspecified number of Adults (Genders unspecified) experienced severe soreness at the injection site immediately following vaccination with HAVRIX 1440. It was unclear how long the pain continued post injection as the sales representative had limited to provide. At the time of reporting, the outcome of the event was unspecified. The healthcare reporter has received numerous reports of pain and stinging at the injection site when administering HAVRIX (AHAVB224AA) to both adults and children. No HAVRIX dose was provided for vaccination given to children. No redness or in duration appeared, but frequent complaints of site started administering a different lot of HAVRIX (AHAVB251AA) and continues to receive complaints of intense pain during and shortly thereafter giving the injection; more than one nurse noted the problem. The site started administering a different lot of HAVRIX (AHAVB251AA) and continues to receive complaints.
Fever of between 100-102 degrees Fahrenheit which lasted for 3+ days; loss of appetite; unusual sleepiness followed by sleeplessness; weight loss; listlessness; soreness and knot in arm where vaccine was administered; unusual delirium/confusion.
Narrative:  Patient had J&J Covid vaccine on 3/31/21. She contacted the agency on 4/12/21 to report lower back pain (more right sided) for a week, pain level 8/10. "I have been using heat/ice, no OTC meds. No numbness/tingling, pain or weakness in my legs. My legs have felt like they were going to give out but haven't." She also reported numbness in her RIGHT thumb on the same day. She went to an outside facility, Hospital on 4/12 for urgent care visit. We do not have access to any records from this visit but the patient was told her symptoms were not related to vaccination. There is no mention an alternate cause for her symptoms. If any tests or labs were run during urgent care visit, those results are not available to us. The patient has never tested positive for COVID. The patient is followed regularly by neurology for migraines, no prior history of back pain.
This spontaneous report was received from a health professional (medical assistant) refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On an unspecified date the patient received an improperly stored dose of (Oka/Merck) VARIVAX. Concomitant medications were unspecified. No adverse effect was reported. This is one of the two reports received from the same reporter (MARRS # 1501USA011420). Additional information has been requested.
Patient experienced twitching in her arm following injection. BP readings 150/110 and 130/100 HR 64 95% O2 on RA BGL 90
No additional adverse event; A patient was administered an improperly stored Pneumovax23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # S036495, expiration date on 13-SEP-2021 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The temperature and time were of 47°F (70° F) for 12 hours, without previous temperature excursion and was not called by a digital data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
I had fatigue, headache, and cough. These symptoms lasted for about a week. I went to medical facility about. They checked me for the flu and exam me. I did a at home Covid-19 test, negative results.
cramping in upper arms; muscle pain in forearms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms). At the time of the report, MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment  medications were reported.
Information has been received from a physician concerning a 16 week old male patient with no relevant medical history or past drug history, who on 26-OCT-2009 was accidentally vaccinated IM with 0.5 ml a dose of PNEUMOVAX 23 instead of PEDIARIX.  Concomitant therapy included a dose of PREVNAR, a dose of ROTATEQ and HIB conj vaccine (unspecified carrier) on the same day.  No laboratory test was performed.  As of 26-OCT-2009 it was unknown if he would continue PNEUMOVAX 23 vaccine and the patient was acting okay.  Additional information has been requested.
Started off with chills, headache and fatigue around 1am. I was also sweating profusely. I took my temp and it was 100.3. Was not able to sleep more than 4hours. I also had terrible nightmares during the little time I was asleep. I started to feel better around 11am that next morning however, I?ve had diffuse abdominal pain  and several episodes of diarrhea throughout the afternoon and evening.
He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself.  A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed,  10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.
Abdo cramps, cried extensively after 1st dose of Rotateq..Loose stools. Bloody stools, occult blood positive.
PATIENT BEGAN WITH A SCALDED LOOK FROM THE NECK AREA UP. HE HAD A BURNED TO LOOK THAT BEGAN AROUND HIS NOSE AND ON HIS EARS AND FACE. HE THEN BEGAN WITH WHELPS ALONG HIS EXTREMITIES. TODAY AFTER EXAMINING IN OFFICE BY DOCTOR HIS EYELIDS ARE PURPLISH AND CHEEKS ARE FLUSHED. NO TROUBLE BREATHING AT ANY TIME.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. Patient received the vaccine. Other medications in two weeks was reported as No.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The report was about COVID-19 treatment. Patient received COVID-19 treatment as Paxlovid from 16Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Diarrhea, vomiting, dizziness and extreme faint/weakness, chills.
Cellulitis on Left upper and lower arms/ deltoid. region. Treatment: Dr. prescribed Keflex.
Received the Moderna COVID-19 vaccine at 0845 on Thursday the 28th of February. Immediately upon injection, the site became red and inflamed. Pt was given 25mg of chewable Benadryl within 45 seconds of vaccine administration. Pt was directed to sit down and vital signs were taken. BP- 145/96 SP02: 99% on RA, HR: 95 RR: 22. Pt was given a cool compress and monitored closely by a Physicians Assistant for 15 minutes. Pt stated he felt that he was ?very anxious, but felt fine.?  Vital signs were taken again; BP 136/78 SP02- 100% on RA, HR: 72, RR: 18. Pt was monitored for another 30 minutes with no other side effects. Pt was given instructions to come back to clinic if symptoms persisted. walked from his car to his office around 1430 and ?felt winded and had difficultly breathing? he also stated he had a ?metallic taste in his mouth around lunch time.? Pt came back to the clinic and spoke to provider who did not feel that patient needed any escalation of care.  Pt was contacted multiple times after incident today and no additional symptoms persisted, at this time.
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization. Patient has not experienced any adverse reactions from vaccine after administration.
I have been ill all day and it is not going away. I  have a headache, brain fog, no appetite, nauseousness, i slept for 21 hours after the shot. I have had msny flu shots - last year along with the pneumonia shot- no issues before. Today I feel like i cannot function. Filling this form out is  torchure.  I have noticed in the last month with my GI issues that my doctor was aware of - my pulmonary dr gave me the flu shot - was aware that my bowels are full of feces and i work closely w a gi specialist to try to  address this as am in constant distress as well as malabsorption and massive mucus when i am able to relieve myself (3 x a month approx w a lot if diarrhoea) but this is different.  He was aware of the meds i am on as well as my medical conditions - he gave me the shot last year - no issues but my health has gotten worse. The flu shot has made me completely dysfunctional. I was very surprised. I am vaccinated for Covid - no issues. What is happening?  Sorry for all the details but I am worried and will be waiting watchfully to see if I recover.
Mother called12/26/02 states (child) had a red,swollen right arm; On 12/24/02, she took him to ER; Started on Iorabid 200 mg for local reaction; To return to ER 12/26/02 for rechecks
Administration error: pt. given Pfizer Bivalent dosage for adult.    Pt. didn't have any adverse signs or symptoms.   Attempted to reach parent by phone ( 08/08/23) to notify them or the error.
Pt. called after 24 hrs of receiving shot. C/O that elbow to her shoulder swollen & hot to touch, very painful. (R) arm.
patient recieved all 3 vaccines in same arm experienced swelling,and pain along with redness to upper arm,lasted 3-4 days,had appointment with ent doctor the following day,he put her on prednisone seemed to help patient is feeling better no complications.n/a