chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started with low grade fever that culminated with pt having fever of 105.6 degrees on 11/16/15.
vaccine expired, used for a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 4th February 2022, patient received a dose of Bexsero by mistake thinking it was not expired, but it was expired on 31st January 2022 The reporter wondered if needed to give another dose or the vaccine had a beyond use date and was still viable. It had been stored in the fridge the whole time. The reporter consented to follow up. No further details provided on web form.  The reporter was unable to reach health care professional and a voicemail was left. . The reporter consented to follow up.
This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown.  10/16/07 T/C to reporter who provided patient demographics.  10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported.  D/C to home 10/6 with f/u scheduled for 10/8.  11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home.  Lethargic w/multiple apneic events at pcp office on 10/8/07.  WBC 16.8, platelets 20,000 in pcp poffice.  Pcp placed on O2 & called EMS.  Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007.  Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated.  Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.
Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) outcome was unknown.        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.   No concomitant medications were provided.  No treatment medications were reported.
2 x 5 cm area of swelling at DTap shot site left thigh. Slight warmth. No tenderness. Red rash.
Heart palpitations, dizziness,  delirious, delayed response to things, sense of being out of it, dry mouth and lips regardless of proper hydration, fatigue, coldness of body (specifically hands).   Heart palpitations would come and go over the course of approx a month and a half, the feeling of being dehydrated although maintaining proper hydration lasted approx 2-3 weeks. Fatigue last approx 2.5 weeks. All other symptoms subsides within 48hrs of initial reaction.  Patient is a pescatarian and had refrained from drinking caffeinated beverages during the appearance symptoms.
Patient came in on 3/28/18 1245pm to report and adverse reaction (SIRVA-Brusitis) from the vaccine she received on 1/26/18. She reports that almost immediately she felt a severe pain at the injection site while she was shopping and almost passed out from the pain. She also reports that it went numb and it felt like dead weight. She began to take ibuprofen and it seemed to go away but till this day she has restricted motion in her left arm and cannot raise it too high. she has an appointment with her doctor this week since the pain and discomfort has been ongoing. Informed patient to let us know how it goes or if she needs anything else from us as well as reassured her that we would be reporting this adverse event.
6-7 days after booster vaccine dose, patient developed severe b/l feet and ankle pain leading to taking hours to get out of bed in morning, difficulty walking, in the morning. Also severe right wrist pain. Symptoms resulted in inability to drive due to pain. Also difficulty sleeping due to pain. Evaluation by primary care office led to diagnosis of rheumatoid arthritis. Steroids started on 10/1/21 and referral to rheumatology made.
This spontaneous report was received from a healthcare worker via company representative and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA (strength, dose, frequency and route were not reported, lot number 1030442 and expiry date 19-DEC-2016). On unspecified dates, there were two instances in which the Hepatitis A "pre-filled vials broke off at the base" (the company representative stated that he was assuming that the healthcare worker was speaking of VAQTA). It was not reported whether this occurred during administration to patients. Product quality compliant (PQC) was involved. On 20-JAN-2016 at 10:45 AM: PQC was filed. No further adverse event (AE) information was filed. The outcome of the event two instances in which the Hepatitis A "pre-filled vials broke off at the base" was unknown. The reporter did not provide causal relationship between the event two instances in which the Hepatitis A "pre-filled vials broke off at the base" and suspect therapy. A "pre-filled vials broke off at the base" and suspect therapy. Additional information has been requested.
presented with altered mental status and SOB; positive for COVID-19 pneumonia;CXR revealed bilateral opacities subjectively they are mild in nature. admitted to the hospital and was noted to have drop in oxygen saturation up to 86% on ambulation. Labs: D-Dimer was negative, serum WBC negative, lactic unremarkable.  CRP 6.35, Procal 0.07  Tx: IV dexamethasone and remdesivir, also rec'd maxipine, Vit C, Lovenox, Singulair, and zind.  His oxygenation has improved;  room air at d/c.
Describe Event, Problem or Product Use Error: [Pfizer vaccine] use for COVID-19 under Emergency Use Authorization (EUA):pt fully vaccinated and tested positive for covid 8/27/2021. hospitalized 8/30/2021 - received tocilizumb and remdesivir, dexamethasone, Oxygen
Fever; Sore arm/ Sore Injection Site; Nausea; Vomiting; Headache; Shivers; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 15th August 2019, refer case US2019190825). Concurrent medical conditions included postnasal drip.   On 20th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st October 2019, 1 days after receiving Shingrix, the patient experienced fever, injection site pain, nausea, vomiting, headache and shivers. Rechallenge with Shingrix was positive. On 21st October 2019, the outcome of the injection site pain, nausea, vomiting, headache and shivers were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever, injection site pain, nausea, vomiting, headache and shivers to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 57 or 58 years. On 21st October 2019, the patient woke up in the early AM with a sore injection site, nausea, vomiting, fever, headache and shivers. Several hours later, these symptoms had resolved. The reporter consented to follow up.
Pt had a positive COVID test on 7/14/21 at Hospital; 8/31/21 pt to hospital and admitted with SOB and cough; diagnosed with pneumonia post COVID and respiratory failure; O2 supplementation; DNR/DNI; desires hospice care and comfort measures; pt expired in the hospital.
pain, swelling, rednes, 101 fever, muscle aches, joint pain, lathargy, confusion & weakness. Took ibupropin.
Developed itchy tingly patchy red rash on L arm. Over next few days, patches expanded and developed vesicles on patches from mid upper inner arm, on inner forearm, and latest on hand and palm.
Not feeling well evening after shot given. Went to ER via ambulance, possible heart attack.
dizziness; increased heart rate; minor incidence of the allergic reaction; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6205) via unspecified route of administration, on 19Mar2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced a period of severe dizziness for 3-4 hours. Patient also had an episode of increased heart rate for 5-10 minutes on unspecified date. Patient mentioned that none of these things happened to her before. Patient queried if she should be concerned about her allergic reactions and is it still okay to get the second dose. Patient also stated she was actually trying to find out the information about the side effects and patient didn't actually have any other side effects. Patient was concerned about she had minor allergic reaction and does that matter if far was going and getting the second shot. Patient stated that why they send me to this number because patient literally being on hold for two hours and 45 minutes. Patient stated it was really super annoying. Patient was unwilling to share further information. The outcome of the reported events of dizziness and increased heart rate was recovered on an unspecified date, and it was unknown for minor incidence of the allergic reaction.  Follow-up (22Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: Clinical course details were added  No follow-up attempts are possible. No further information is expected.
(L) supraclavicular lymphadenopathy - chest x-ray, blood work, referral to oncology.
Info has been received from a physician concerning a 78 year old white male physician with a history of a stable abdominal aortic aneurysm and high cholesterol, who on 7/9/02 was vaccinated, in the left deltoid, with a 1st dose of Hep-B (invalid lot 06555) and on 9/5/02 was vaccinated, in the right deltoid, with a 2nd dose of Hep-B vaccine. On 9/15/02, the pt developed distal leg numbness described by the pt as a "sensation that my left foot was asleep". Over the next few days, this "feeling moved up the leg" and at the same time, the "same process started in the right foot and moved up the leg". On 9/20/02, the sensation had "risen to the waist" and it "felt like I had tights on constricting the lower half of my body". On 9/20/02, the pt 1st noticed some difficulty walking and on 9/21/02 he "could not walk unassisted". On 9/21/02, the pt also had trouble initiating micturition and "felt like I had crashed". On 9/22/02, the pt went to the ER and was admitted to the hospital. The pt's LP on admission, revealed WBC-14, neutrophil-18, protein-183 and normal glucose. Tests for West Nile Virus and Lyme's Disease were negative. The pt's computed tomography showed hyper-density at T10-T11. Transverse myelitis was reported and the pt was treated with IV steroids. On 9/27/02, the pt was discharged from the hospital. On 9/30/02, it was reported by the treating physician that the pt was walking and recovering. Follow-up info from the pt indicated that he "started to improve" with the IV steroids while in the hospital. but he has not recovered. The pt also reported he still had "sensory changes which were marked from the waist down", there was a "loss of strength in both legs", his "balance continued to be lousy", he walks with a cane, he was going to a rehabilitation center 3 X a week and he has noted "some improvement". The pt considered his adverse experiences to be a life-threatening illness, to have resulted in a persistent or significant disability/incapacity and to be an "Other Important Medical Event". Additional info has been requested.
Initial report received on 07-Nov-2013 from a health care professional. A 4-year-old female child whose medical history and concomitant medications were not reported, received a intramuscular dose of FLUZONE QIV (lot number U4772AA; expiry date unknown) on left deltoid on 04-Nov-2013. It was reported that the patient experienced redness at the injection site with erythema and induration on 07-Nov-2013. The events were ongoing at the time of the report. List of documents held by sender: none.
night sweats; fever; fatigue; muscle ache; chills; really dizzy; felt flushed in the face; cheeks were red; cheeks were swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (really dizzy), FLUSHING (felt flushed in the face), ERYTHEMA (cheeks were red), SWELLING FACE (cheeks were swollen) and NIGHT SWEATS (night sweats) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (really dizzy), FLUSHING (felt flushed in the face), ERYTHEMA (cheeks were red), SWELLING FACE (cheeks were swollen) and CHILLS (chills). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (really dizzy), FLUSHING (felt flushed in the face), ERYTHEMA (cheeks were red) and SWELLING FACE (cheeks were swollen) had resolved and NIGHT SWEATS (night sweats), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle ache) had not resolved. Not Provided      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.   On an unknown date, Blood pressure measurement: result-unknown. On an unknown date, Oxygen saturation: result-unknown.
2.5 days after Covid vaccine #2, I developed left leg stiffness, a recurrence of my symptoms associated with Stiff-Person Syndrome. I was originally diagnosed with SPS in 2013, and had complete resolution of all symptoms following a course of IVIG, with no symptoms since 2017. The same left leg stiffness which I had previously recurred two days after vaccine administration. I saw my neurologist, who thinks that the vaccine stimulated an immune response with an increase in antibody production, and since this condition is associated with elevated B cell antibodies (anti-GAD antibodies), this may be temporarily triggering symptoms.
Pt recv vax on 10/9/98; on 10/30/98 pt exp vesicular lesion at vax site w/ lesions on trunk, back & face
edema in major joints & especially lower legs; severe sinus swelling; my major joints swelled up; extremely painful to move; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 05Feb2021 (Lot Number: EC9269) at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included a history of allergies and take have taken allergy shots for years. Known allergy was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included tamsulosin hcl, testosterone (ANDROGEL), sildenafil, simvastatin and overran. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 15Jan2021 (Batch/Lot Number: EC1284) at the age of 78-year-old as single dose for COVID-19 immunization. On 07Feb2021 at 12:00, the patient experienced edema in major joints, especially lower legs and severe sinus swelling. 2 days after 2nd dose the patient was feeling OK, so he went for a walk (first exercise since vac). About 1/4 mile out his major joints swelled up and began extremely painful to move. Edema slowly reduced, he tried compression socks which helped some. About 3 months later, he saw internist who sent him to a vein specialist. He thinks the patient will have a permanent problem with edema. The patient was scheduled for an echocardiogram and vein ultrasound. He think that this is too much of a coincidence to be another cause. The patient was concerned about getting a booster because he may sustain further permanent damage to he vascular system. In addition to edema, the patient's sinuses swelled up and required a month of heavy-duty medication (Chance) to return to their normal swelling. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Hospitalization Prolonged was none. Treatment was received. The outcome of events was recovered with sequel.
Moderna inadvertently given to client under 18 y/o.  Left message for parent to call.
Vaccine Administration Error.  Bivalent Booster should of been given.  No reactions reported.
pt recvd vax; 1/2 hr later,pt "blacked out"; poss fainting x 1 min;hit face on pavement inject; fx nose & broken front 2 teeth; tx in er; IV x-rays; front teeth repaired, released same day;
EDD: 01/27/2022 Miscarriage, 08/2021
erectile dysfunction; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (erectile dysfunction) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (erectile dysfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (erectile dysfunction) outcome was unknown.            Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within minutes of vaccinating the patient wants to go. He is immediately pale and sweaty. S/V BP 80/60 Sat 92% P-59 Dxt 92 mg/dl 12:10 pm BP 100/80 Pt hadn't had breakfast. 12:30 pm Pt stabilized and left accompanied by his driver.
Pt's guardian was asked and counseled about vaccine: (ie No past vaccine complications, no allergies, not sick today) etc. Got vaccine. About 10 min later, returns to Pharmacy feeling faint, flushed. Sat in chair, rested about 10min.
Fever of 101.2 at 11:30pm 3/26 101.5 at 11AM 3/27 102.11 :00pm 3/27 , Chills, nausea, dizziness, headache, fatigue, weaknesz, muscle soreness , muscle tightness and weakness at injection site all starting 11PM 3/26 , Cough, sore throat starting 10AM 3/27
patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medication history was provided.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second). At the time of the report, WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown  Treatment information was unknown