chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient sat down and alerted observation that he was experiencing feeling flushed and felt his pulse was faster than usual. He took off his jacket to cool down. As time progressed, he said he did not feel as dizzy. Patient was in observation for over thirty minutes. EMS arrived at scene to evaluated patient. Patient signed a refusal form to go to the hospital and to receive treatment. Pulse 76, pressure 121/83, oxygen was 96.  Patient was instructed to download the app .
mom reports t105 the noc p/last dose of vax 29NOV94; T lasted 12 hrs fluctuating between 103 & 105; mom did not seek medical care, but gave APAP & a cool bath
Approximately 24 hours after receiving the second dose of the Moderna vaccine the patient consumed alcohol (3 alcoholic beverages over the course of 2.5 hours which is a typical consumption rate for the patient). The patient then experienced a sudden onset of vomiting and dizziness. Vomiting continued for approximately 12 hours. Lethargy was present for the following 36 hours. Symptoms then resolved on their own without treatment.
Note: These symptoms are from the second injection of the vaccine; first was March 11...no problematic symptoms from that one. Symptoms started at midnight on April 2 (10 hours after injection) with chills, not sure if accompanied by fever.  By 8:00am, chills subsided, but had body aches and headache the rest of the day and though the night.  Ended by 8:00am on April 3.
nausea same evening as vax;over next 4 days flu-like sx w/fatigue, h/a, arthralgia in elbows & knee, sore throat;29APR devel rash on arms, spread to chest, face;no cough;no Gi sx tx atarax cleared by 1MAY99
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes.  Nausea 12/26-12/27.  Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
Soreness at the injection site; redness in the area of the injection spreading toward the chest; Fever (101° F degrees); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (101° F degrees)), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Fever (101° F degrees)). On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest). At the time of the report, PYREXIA (Fever (101° F degrees)), INJECTION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (redness in the area of the injection spreading toward the chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "latex allergy" (unspecified if ongoing); "Shingrix reaction" (unspecified if ongoing), notes: She said she had Shingrix reaction. The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of pruritus. Additional information: A female patient called about the new Pfizer Covid vaccine Comirnaty 2023-2024 formula. She has latex allergy. She set aside the next 2 weeks to have her flu and Covid vaccines for the rest of the year. She'll go to her HCP or might get the Covid vaccine from local pharmacy. She said she had Shingrix reaction. Her allergist is a teaching immunologist. Her local health department and pharmacist weren't willing to give the original Covid vaccine to her before. So, her allergist wrote an allergy action plan for her, and advised her to take cetirizine, Pepcid (H1N1 blocker) and oral steroid. Having prescribed that cocktail allowed the pharmacist to feel secure to give the very first Covid vaccine. She said she only did have itching. She was monitored and allowed to get the next 3. She said she had total of 4 Pfizer Covid vaccines, she did not have any bad reaction to any. She said that the last one (Bivalent), she had nothing, no reaction at all. And so, she doesn't need to take steroid needlessly she said. She added that she doesn't intend to turn herself into a DM2 and so, she won't be taking the steroid, but just the other 2 medications. Also mentioned that her doctor died of Covid. She also asked if she can take the last one (Bivalent) if it's still available and if Pfizer now have Comirnaty listed as being safe for those who have latex allergy.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Broke out in blisters around injection site. Resolving when examined on 03/02/2005. Given Bactolum to prevent infection.
Spoke with patient today, 10/22/2009. She had NO reactions to her FLUARIX Immunization.
Patient is a 82 y.o. male patient of MD admitted to HCF on 11/9/22 due to complaints of chills and weakness.    Per Admission Information: Patient is a 82 y.o. year-old male, who presented with chills and falls.  The history was obtained from the database and validated with the patient.  He is a 82 y.o. male who presents with a chief complaint of Chills and Fall.  Patient presents emergency department for generalized weakness and multiple falls since Saturday around 5 days ago.  Patient notes that he has had 2 falls since then.  Patient notes that one of the falls he did hit his forehead.  He notes that fall was about 4 days ago.  Patient denies headache, dizziness, nausea, vomiting, numbness, tingling, unilateral extremity weakness.  Patient denies worsening or increased cough and congestion.  Patient's family is at bedside and notes that he has a chronic cough as well as chronic diarrhea at baseline which has been unchanged.  Patient has had multiple hospital stays over the last several months and was recently discharged from a different HCF.  They note that the patient has had a steady decline since being discharged from his skilled nursing facility.Family notes that the patient has had a "tremor and shaking all over his body".  Patient states that it is because he feels cold all the time and he is shivering.  Patient notes that he has had a decubitus ulcer to the left buttock.   Hospital Course: Patient diagnosed with COVID-19 infection upon admission to hospital. Initial CXR showed slightly improved aeration at the lung bases; bilateral interstitial opacity persists which could be mild edema or atypical infection. Patient required 2L of O2 via NC initially, but is now on RA, which is his baseline. Patient on isolation until 11/19/22. Patient treated with IV Rocephin and IV Decadron. Patient initially hypoglycemic as well. All oral diabetic medications stopped and patient placed on sensitive SSI. BG has since normalized. Patient will restart Farxiga per home instructions upon discharge. Appetite has improved. Initial UA demonstrated UTI. UC showed E. Coli positive. Not susceptible to cipro. Will transition to oral macrobid. Patient completed three days of IV Rocephin. He will complete four days of macrobid for total of 7 days on antibiotics. He is encouraged to follow-up with his provider at office, whom he sees for his prostate cancer. Coumadin resumed at home dose. To follow with PCP on Monday for re-check of PT/INR and additional coumadin dosing. Patient seen by care manager. Will go home with HHC.    Patient in stable condition at time of discharge. Discharge education provided. Patient to follow-up with PCP on Monday.    Discharge Diagnoses: 1. Persistent hypoglycemia in setting of DM type 2 2. COVID-19 3. Deconditioning 4. Falls, multiple 5. DPU left coccyx POA 6. Morbid obesity BMI 41.44 7. Chronic Afib 8. Urinary retention 9. UTI, E. Coli 10. Follows at PCP office for metastatic prostate cancer (mets to bone and lymph) as well as malignant neoplasm of dome of urinary bladder.
Throat closing, tough to swallow, tight chest, eyeballs hurt - lasted 6 hours. Headache, rapid heartbeat, muscles hurt lasted - 12 hours.
Large (approximately softball size) red area, swollen and itchy at the injection site.  Today 11/07/2014, red area slightly bigger, but not as bright red, and still itchy per mom.
Raise, red rash (whelps) on forehead, temples, chin itching.
Pt received COVID 19 Vaccine on 12/16/20. During 15 minute Observation; pt complained of Palpitations about 5 minutes into Observation. The nurse assisted pt to Overflow Observation room. Nurse Manually check Pulse; Pulse 68, A/O x4.  Pt provided water and crackers. Pt stated her Palpitations have resolved on their own in about 4-5 minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. Approximately on an unknown date in December 2012 (reported as a year after) the patient was vaccinated with GARDASIL dose 1. No concomitant medications were reported. On 02-DEC-2013 the patient was vaccinated with GARDASIL dose 2 one year after the first dose. No adverse effect was reported. Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that when the lot number of Moderna Covid-19 vaccine of 010A21A is entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021.  Reporter also had a screenshot of the above lot number 010A21A entered into the lot number expiration date look up program on Modernatx.com that shows the expiration date as 14-Oct-2022.The vial did not undergo any temperature excursions.  No treatment information was provided.
C/O FEVER 100.9; BODY ACHES; EDEM TO RIGHT AXILLA LYMPH NODES; HA.
Patient is fully vaccinated.  COVID + on admission to hospital.  84-year-old female who presented to the hospital with altered mental status, found to be in the setting of acute hypoxic respiratory failure due to covid 19 pneumonia. CXR: Findings suggest mild pulmonary vascular congestion with a right basilar airspace opacity and a small to moderate right pleural effusion. She was treated with supplemental oxygen, IV steroids, breathing treatments.  She was also treated with IV remdesivir And completed the full 5 day course.  Her mentation improved back to baseline.  She also had a TIA and was provided with IV hydration, which improved her AKI. Cr 1.25. D-dimer is elevated. Discharged -home care services.
Pt. stated she has been experiencing swelling, soreness, rash like symptoms in her (R) arm recommended pt. to take NSAID, antihistamine, elevate arm and monitor/contact MD if worsens.
Significant/severe and painful joint and bone pain all over body.  Lasting over two months.  Finally decreasing.
Excruciating upper arm pain that was significantly more severe than standard sore arm. Chills, headache, worse pain than broken wrist I once suffered.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This Case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848.(same reporter, same vaccine, same lot number). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017, site: unknown and dose was not reported) intramuscularly, on 04 October 2016 (also reported as over the past month). Previous doses were reported as unknown. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient experienced rash (2-3 inches wide) at site, arm sore and swollen. It was reported that the patient required emergency room/doctor visit. Lab data was not reported. Patient received no corrective treatment (sought out treatment). The outcome of the events was reported as unknown. List of documents held by sender: none.
the patient did not experience any other adverse events; patient administered MMR in their office and given a VARIVAX in another office less than 4 weeks apart; This spontaneous report was received from a registered nurse and a consumer and refers to a 12-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 08-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 mL (site of vaccination not provided) (lot#T015997, expiration date 08-MAY-2022) for prophylaxis. On 22-OCT-2020, less than a month after the first vaccination, she was vaccinated with rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (site of vaccination not provided) (lot# S037498, expiration date 04-OCT-2022) reconstituted with sterile diluent (lot# T005076, expiration date 04-OCT-2020) for prophylaxis. The consumer wanted information on validity of the vaccines that were administered less than a month apart. No adverse events were reported.
Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) had resolved.        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 product use was not provided by the reporter.   Treatment information was not provided.
mistakenly the facility gave MENACTRA to a 4 month old child with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid non-serious case from other health professional via call center.  This case involves a 4months old patient of unknown gender who was mistakenly administered Menactra by the facility with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Feb-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength, dose, batch number, route, administration site : unknown) for immunization. Information on batch number was requested.  On 28-Feb-2022, the patient was mistakenly administered Menactra by the facility with no reported adverse event (product administered to patient of inappropriate age) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the events (product administered to patient of inappropriate age).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Patient has DTaP and Varicella Vaccine at approximately 0910. Patient was sent to lab approximately 35 mins after injection.  Patient had syncopal episode a few mins after blood draw. 0950, patient was sent to Emergency Room and evaluated. May have had syncopal episode from neelde stick?
Information has been received fro a pharmacist concerning a 24 year old female with an allergy to cephalosporins and no medical history, who on 14-OCT-2006 was vaccinated SC with a 0.5 mL dose of Pneumovax 23 (lot# 651399/0486F) and influenza virus vaccine (unspecified). Concomitant therapy included hormonal contraceptives (unspecified). Several hours later, the patient experienced tenderness, warmth, swelling, and redness at the injection site and soreness of the whole arm with movement. The patient was treated with BENADRYL and TYLENOL. ON 16-OCT-2006 the patient saw a doctor who ordered AUGMENTIN and VICODIN. It was noted that the patient was being referred to an Infectious Disease Specialist. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Face was drooping like bell's palsy; Swollen Lips; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Face was drooping like bell's palsy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Swollen lips (thought was due to working as a land scraper (had happened previously)). Concurrent medical conditions included Milk allergy (had ice cream around the same time as the first dose).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced BELL'S PALSY (Face was drooping like bell's palsy) (seriousness criterion medically significant) and LIP SWELLING (Swollen Lips). At the time of the report, BELL'S PALSY (Face was drooping like bell's palsy) and LIP SWELLING (Swollen Lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LIP SWELLING (Swollen Lips) to be unlikely related. No further causality assessment was provided for BELL'S PALSY (Face was drooping like bell's palsy).    Concomitant medications were not provided.   The patient took second dose of Moderna vaccine with no adverse effects.   Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field. On 30-Jul-2021: Follow-up contains patient's other relevant history and second dose details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT SAID THE SWELLING INCREASED IN SIZE AND  FELT VERY WARM. PATIENT WAS CONCERNED ABOUT INFECTION AND PLANNED TO GO TO AN URGENT CARE FACILITY
Information has been received from a pharmacist via a field employee referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength and route unknown). 3 to 5 days after the vaccination, the patient experienced redness, itching and swelling at the injection site. No rash was present. The patient was administered BENADRYL for treatment and would be going back to the pharmacy on 06-NOV-2015 for follow up. The outcome of the events was unknown. Additional information has been requested.
shaking of all extremities x 2min w/confusion;no fever, no lethargy, no cyanosis or pallor occurred twice-same afternoon p/vax given in AM;
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (which had the lot number of L024265, expiration date 01-JUL-2017) (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Swelling of entire left upper leg -> hip knee. Positive erythema. No increased warmth.