chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine at 1:55 pm, took nap, awoke at 5:00 pm nausea, chest tightness, diaphoresis, flushing throat felt swollen, face tingling. Took BENADRYL 25 mg PO without help. Taken to ER via rescue squad at 7:30 pm. CXR okay, EKG okay. Received IV steroid and BENADRYL.
Hives, itching, and soreness surrounding injection site. Also experienced cough, and cold symptoms. Inflammation of right arm documented. Treated in Urgent Care with Prednisone and ATARAX.
Moderate dizziness, nausea, chill, fatigue started around 5 pm lasted throughout evening. Had to take zofran 4 mg ODT for nausea.  No known fever. Unable to drive home from work for 2 hours. Went to bed around 11 pm. Felt better the next morning with mild residual dizziness and chill and fatigue. Minimal chill and fatigue ongoing at 55 hours after injection. Left arm injection site pain started at time of injection and ongoing after 55 hours.
Patient is a 64 y.o. male who presented from home on 12/8/2022 with worsening hypoxia in the setting of COVID.  On admission he was also found to have CAP.  His oxygen requirements improved with antibiotics and steroids. Pt was discharged home on 12/10.    Discharge Diagnosis and Associated Hospital Course   Acute Hypoxic Respiratory Failure - In the setting of multiple respiratory infections as below. - On admission was requiring NRB/HHFNC, now weaned off and stable on RA. - cont IS   Severe Sepsis without Shock - improved Community Acquired Streptococcus Pneumonia - Meeting SIRS criteria and with evidence of end organ dysfunction on presentation, improved with empiric treatment. - CTPA with LLL consolidation, concerning for CAP.  Urine antigens positive for Strep Pneumoniae. - Continue empiric Levaquin therapy, end date 12/14.   COVID-19 - With symptom onset reported 11/27, tested positive 12/2. - Had started Paxlovid and steroids outpatient prior to admission. - Continuing Decadron for 10 days.   Metabolic Acidosis - resolved - Elevated Lactate of 4.8 in the ED in the setting of hypoxia and sepsis as above. - Normalized with resuscitation.   Insulin Dependent Diabetes Mellitus Type 2 with Hyperglycemia - A1c of 8.5 noted 4/2022. - Hyperglycemia in the setting of acute illness and steroid administration. - Home regimen includes glyburide/metformin, Lantus 43 units nightly, 18 units Lispro TID AC.   Mild Hyponatremia - Unclear etiology, though to be at least partially related to interval hypervolemia in the setting of volume resuscitation. - resolved. - Administered one dose of IV Lasix in ICU 12/9.     Elevated Troponin - Elevated on admission and then downtrended, with apparent up-trend thereafter. - Presumed to be in the setting of sepsis and relative hypoxia.  Patient denied chest pain throughout this admission. - Echocardiogram 12/9 without focal WMAs.  ECG without focal ST elevations or depressions. - No further work-up inpatient.  Essential Hypertension - Home regimen of Clonidine 0.2mg TID, lisinopril 40mg, and metoprolol 100mg resumed.   History of Gout - Continued allopurinol.   Major Depressive Disorder - Continued home Celexa.   Obesity - BMI 35.83 - Continue to encourage lifestyle and dietary modification as tolerated.   Possible OSA - With snoring noted in ICU, high suspicion for underlying OSA. - Referral to sleep clinic being coordinated by ICU team, appreciate assistance.
Left Transverse and sigmoid   Cerebral Venous  Sinus Thrombosis in a patient with Chronic left Mastoiditis and previous Hx of VTE. I do not believe this was likely an AE from vaccine
Two weeks after administration of vaccine, suffering chest pain, bleeding excessively from minor cuts with extremely slow clotting.  Spontaneous bleeding from small cuts.  Pain in chest, shortness of breath, severe fatigue.  Severe joint pain in shoulders, hips, knees, elbows, ankles, hands, toes, spine, and neck not eased by pain medicine, warm baths, or laying down.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015 at 04:10, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 12.0 and 0.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
i got the COVID; i got the COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021), on 08Mar2021 as dose 2, single (Lot number: EN6206, Expiration Date: 30Jun2021) and on 18Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i got the COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; eye pressure: High. Clinical course: Consumer (Nurse Practitioner) stated, "I have had a question about the Pfizer booster shot, I was able to get the first two Pfizer COVID-19 Vaccines without any reactions or side effect at all and I got the Bivalent without any reaction at all but when I got the COVID, the Pfizer COVID Booster shot and this was in Dec2021, three week after I got that shot.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid 19, vaccination failure cannot be excluded.
PT HAD GOTTEN A RED HOT PUFFY AREA NEAR INJECTION SITE THAT DISSEMINATED AROUND AND BELOW INJECTION SITE THE UNDER SIDE OF THE UPPER ARM.
Information has been received from a consumer concerning her 8-year-old white son with allergies who on 22-FEB-1999 was vaccinated subcutaneously with a dose of Varivax (date unspecified). Concomitant therapy included montelukast sodium (MSD) and sodium fluoride. On 16-APR-2006 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought; no laboratory or diagnostic tests were performed. At the time of the report the patient was recovering. No product quality complaint was involved. Follow-up information received from the mother indicated that the patient's immune system was way below normal. One week post chickenpox, on approximately 23-APR-2006, the patient ended up getting strep throat. However, the mother did not know this at the time because he was not complaining. Three weeks post vaccination, the mother brought the patient back to the physician for a rash. One and one half weeks after that, he developed a severe internal rash all over his body. The patient was diagnosed with scarlet fever. He was treated with 400 mg amoxicillin for 7 days. The mother indicated "so far, he is better." Follow-up information from the nurse practitioner indicated that the patient developed chickenpox on 17-APR-2006 and subsequently recovered. It was reported that the patient's sister developed an adverse reaction following vaccination (WAES# 0604USA03960).
Case number PHHY2012US053750 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient's medical history included of congenital heart disease (not specified). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died to congenital heart disease. No other information was available. Authors stated that the adverse event profile after 2009-H1N1 in VAERS was consistent with that of INFLUENZA, although the reporting rate was higher after 2009-H1N1 than INFLUENZA, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).
woke up screaming several times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-010540 (Moderna case), 137265 (Moderna AE#), U1075497 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, She mentioned her daughter got 3 Pfizer vaccines and had really bad reactions.), for Covid-19 immunization, reaction(s): "Covid"; Bnt162b2 (2nd Dose, She mentioned her daughter got 3 Pfizer vaccines and had really bad reactions.), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: SCREAMING (non-serious), outcome "unknown", described as "woke up screaming several times".  Additional information: The reporter called and indicated that she had 5 fractures in her shoulder and her humerus bone was turned. She stated that her doctor told her to let it heal and the reporter is asking if we had any information on if this would affect her ability to get the booster. During the call the reporter stated that she is immunocompromised and also had reactions to the previous doses. She said after the first 2 doses she was really achy and tired; it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days). She also mentioned joint aches. For the third dose she had more reactions like fever, body aches, nausea (3 days). She stated that the third dose was worse than the first two. In addition, she mentioned her daughter got 3 Pfizer vaccines and had really bad reactions. She woke up screaming several times and got COVID shortly after. (Non-Moderna AE) Moderna 1st dose: 6Mar2021, 027A21A. Moderna. 2nd dose: 3Apr2021,036B21A. Moderna 3rd dose: 24Oct2021, 012F21A  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2nd dose vax experienced dizziness, h/a & URI, otitis media, rhinitis & tinnitus; 1wk later seen & an allergic rxn was dx; Given 1st dose of vax w/o rxn;
When patient  woke up this morning his arm was swollen to twice the size and it was warm and painful to the touch. I instructed him to use an ice pack and ibuprofen to help with discomfort.
pt to ED with c/o SOB x 5 days that is worsening; productive cough, sore throat, loss of appetite; O2 supplementation; found to be positive for COVID; given Albuterol and Dexamethasone, Zinc, Vitamin C and D; pt's condition worsened; transitioned to DNR; continued to decline clinically; pt passed away in the hospital
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 at 19:00 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 at 20:00 as dose 2, single (Lot number: EW0162), in left arm, on 16Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 14May2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (31Aug2022) Negative, notes: negative tests; (03Sep2022) Negative, notes: negative tests; (05Sep2022) Positive, notes: Antigen test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment of COVID-19 included Paxlovid from 26Aug2022 to 30Aug2022 of lot GE0257. no known allergies. other medication in 2weeks product included Lisinopril/HCTZ, other medication in 2weeks brand Lupin Pharm, other medication in 2weeks with start date Aug2022.
There was no adverse reaction. We are reporting that we administered the vaccine to someone that is under the age of 18. This person volunteers at our clinic.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with doses of RECOMBIVAX HB )route, strength, lot# and dose were unknown), which were exposed to temperature outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Area of induration measuring 8 x 9 cm over R deltoid. 24 hours after receiving vaccine inflammation started per pt. Pt seen 48 hours after vaccination.
8 hours post the vaccine the pt experienced severe nausea, vomiting, diarrhea, fever , chills and aches
PT HAD INJECTION SITE REACTION SWELLING ,REDNESS, BLISTERS, MUSCLE PAIN LEFT ARM
Arrived from a residential facility on 8/10 with anemia and worsening repiratory failure. Previous hospitalization 7/27-8/5 for covid pneumonia. Started IV antibiotics and consulted nephrology for dialysis. Patient was too hypotensive for first dialysis attempt.  Midodrine was intitiated with fluid resuscitation. Next day tolerated dialysis but could not pull any fluid. Started cardizem drip due to worsening RVR.  Unable to tolerate dialysis consistently and became encephalopathic and nonverbal after first full session.  POA involved in care being given and requested comfort care.
vaccine sprayed out between the needle and the syringe with no reported adverse event; the plastic hub attached to the syringe where the needle screws on is loose and spins, no AE; vaccine sprayed out between the needle and the syringe and into the face of the patient with no reported adverse event; Initial information was received on 07-Dec-2021 regarding an unsolicited valid non-serious case from a nurse via physician.  This case involves patient (demographics unknown) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] which sprayed out between the needle and the syringe and into the face of the patient as a result of the plastic hub attached to the syringe where the needle screws on was loose and spined (underdose, needle issue and exposure via skin contact).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7384LA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose, needle issue and exposure via skin contact (latency same day).  It was reported "A medical assistant was administering this vaccine and the vaccine sprayed out between the needle and the syringe. When I looked over the needle and syringe, I noticed the plastic hub attached to the syringe where the needle screws on is loose and spins. My thoughts are when our MA tightened the needle onto the syringe the hub spun and did not allow the needle to be tightened properly. I did check the other syringes in this same box and the plastic hubs do not twist, they are fixed into place. Nurse (RN) reports that FLUZONE QIV NP syringe was used on a patient and that the hub was loose on the product and when the MA went to administer the product the fluid sprayed out between the needle and the syringe and into the face of the patient"  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.
The initial symptoms were as though somebody had been punching me in the arm repeatedly. Within two hours the pain was excruciating end I could not move my right arm. The pain went from below my elbow to above my shoulder and into my back. I called the office and they told me to just put ice on it. Seriously the pain was unbearable
He is having extreme fatigue as well as a swollen left axillary lymph node and occasion moderate headaches pain level 5-6/10
Rash. a company representative reported that a pt received Prevnar and within 24 hrs developed an itchy rash. No further information was available at the date of this report.  This is on of two pt from the facility who experienced an event following receipt of Prevnar. See related case number HQ1288324MAY2001.
Pr developed local reaction with cellulitis Rt arm resolved after taking oral KEFLEX for 7 days.
Administration of a second dose of Havrix an Hiberix to a patient. First doses for each vaccine were given on 10Mar2021 / second doses on 17Mar2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old female patient who received Hib (Hiberix) (batch number J3Z99, expiry date 7th November 2021) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Concomitant products included HAV (Havrix) and Hib (Hiberix).   On 17th March 2021, the patient received Hiberix and Havrix. On 17th March 2021, unknown after receiving Hiberix and Havrix, the patient experienced drug dose administration interval too short. The action taken with Havrix was unknown. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details was reported as follows: The reporter wanted guidance in for the administration of a second dose of Havrix an Hiberix to a patient. First doses for each vaccine were given on 10th March 2021 and second doses on 17th March 2021. The reporter confirmed that the doses received on 10th March 2021 should had been last doses for the patient.  The reporter consented to follow up.  Follow up received from physician on 10th April 2021: The patient's demographic details were updated. The patient was erroneously given the vaccines hepatis A and HIB on 17th March 2021. Patient had already received these vaccines on 10th March 2021.  Interval between vaccines too short. On 18th March 2021, the reporter made a follow up phone call, spoke to the patient's father, the reported patient was doing well. VAERS information also updated.
severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from a contactable physician (reported for herself). A 41-year-old female patient (Pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3248), via an unspecified route of administration on 10Jan2021 08:30 at single dose for COVID-19 immunization. The patient's medical history included Allergies to amoxicillin. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (lot number: ek9231) on 22Dec2020 21:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills, severe nausea (no vomiting), neck aches, headache on 10Jan2021 20:30. Treatment received for the adverse events included tylenol 1g x3 doses. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Jan2021.
Mild chills, body aches particularly in the neck and back lasting 9-11 hours
Also she had blood in her stool; Her urine was really yellow and then she hydrated and was still yellow; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Also she had blood in her stool) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE, METFORMIN, PRAVASTATIN, CETIRIZINE, METOPROLOL, HYDROCHLOROTHIAZIDE and TOCOPHEROL (VIT E [TOCOPHEROL]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Also she had blood in her stool) (seriousness criterion medically significant) and CHROMATURIA (Her urine was really yellow and then she hydrated and was still yellow). At the time of the report, HAEMATOCHEZIA (Also she had blood in her stool) and CHROMATURIA (Her urine was really yellow and then she hydrated and was still yellow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The case refers to a 58-year-old female who received Covid-19 vaccination.  Based on the current available information and temporal association between the use of the product and the start date of the events, Hematochezia and chromaturia, a causal relationship cannot be excluded.; Sender's Comments: The case refers to a 58-year-old female who received Covid-19 vaccination.  Based on the current available information and temporal association between the use of the product and the start date of the events, Hematochezia and chromaturia, a causal relationship cannot be excluded.
she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; This spontaneous report was received from a nurse referring to a female patient of unknown age or gender.  The patient's concurrent conditions, historical conditions, drug reactions, allergies, concomitant medications were not provided. The patient was not pregnant.  On 02-MAY-2019, the patient, who was also the nurse, got inadvertent exposure in her eye to one droplet of one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R026548 (expiration date 17-SEP-2020) (dose, frequency, strength, were not provided) (occupational exposure to product, accidental exposure to product, and exposure via eye contact). No additional information provided.