chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was giving vaccines to Patient, a six mold old child vaccines ordered was Pentacel, Prevnar 13 and Hepatitis B. Mother was present at all time child reacted well to the firs vaccine giving Pentacel did not cry, second vaccine was hepatitis B, patient started to cry. When the last vaccine giving Prevnar 13 patient cry excessively and hold his breath at the he was turning purple. My reaction was to blow air on his face pick him up from the table right away. He started to cry normal and look normal, but couple seconds later he look like he was going to pass out and was rolling his eyes backwards.So I call code blue and Doctor went in to the room and the LVN with the emergency kit and the oxygen tank. When everybody arrive to the room the child was crying and breathing normal there was no need for any oxygen. Doctor exam the child and said he is ok. By the time the mother was crying and scared and said he usually holds his breath but not for this long, patient waited for couple minutes in the room and leave.
Had flu shot 11/2; Noticed red area 11/3; Area is itchy/warm; no fevers/chills; otherwise feels okay; her methotrexate is due today; has no allergies to eggs, latex or other than peroxide; no h/o reactions to flu shots; she is able to use the arm normally; she has a small mark that may be a bug bite in the area as well; no trouble swallowing/speaking/tongue swelling etc; Opted to treat with topical steroids, cephalexin in case of cellulitis and may take medrol dose pack if not improving in next 48 hours; Reviewed ER precautions for anaphylaxis; discussed w patient. unclear if reaction to vaccination vs appears small bug bite not in area of vaccine administration reviewed options/ddx with pt; opts topical HC cream, cool compresses and coverage with cephalexin orally; if not improving or if worsening over next 48hrs, will initiate medrol dose pack and seek re-evaluation; Medication risks and benefits as well as the common side effects were discussed with the patient; she felt comfortable monitoring closely.
MAJOR FLARES; STRESS; ANXIETY; This spontaneous report received from a patient via other manufacturer concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 116850 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 36 years old. No concomitant medications were reported. On an unspecified date, the patient experienced major flares, stress, and anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from major flares, and stress, and the outcome of anxiety was not reported. This report was non-serious.
15 year old volunteer was vaccinated; A spontaneous report was received from a physician concerning a 16-year-old male patient (also reported as 15 year old volunteer) who was participating in the mRNA-1273 Emergency Use Program and was vaccinated.   The patient's medical history was not provided. No concomitant medications were provided.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 in his right deltoid for prophylaxis of COVID-19 infection and the mother is upset. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event inappropriate age at vaccine administration was resolved on 10 Jan 2021.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown whether patient was ever diagnosed with Covid-19. The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown. No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Case number PHEH2015US010531, is an initial spontaneous report received from a nurse on 01 JUN 2015. This report refers to a 21 year old male patient. Historical condition and concomitant medication were not reported. On 29 MAY 2015, he was vaccinated only with the liquid component of RABAVERT (batch number: 564011A) via intramuscular route, second dose. After vaccinating the patient stated that "the medication burned".  Outcome of the event was reported as complete recovery on the same day. Seriousness and causality was not reported.
Asymptomatic  ED to Hosp-Admission  Current  10/21/2021 - present (25 days)  Hospital Patient is an 51 y.o. female with past medical history of breast cancer with metastasis to brain, hypertension, hyperlipidemia, anxiety and depression who presents to Hospital with generalized weakness.  Most of the history is obtained by speaking with the patient, her daughter over the phone and review electronic medical records past with a history, patient reportedly was feeling extremely weak since yesterday.  Daughter reported that she was not able to move around her home.  She was unable to lift her legs which is unusual for her.  Patient also reportedly had fall few days ago and is complaining of right rib cage pain.  This morning, patient was supposed to go see cancer care Associates for her follow-up appointment however patient's daughter reported that she was not able to move her extremities which concerned her for possible underlying stroke hence  EMS was contacted.  EMS found that her blood sugars were 40 and she received dextrose on her way to the hospital.  Patient reportedly has been eating at her baseline per the daughter.  Patient does report headaches but denies any vision changes fevers chills cough chest pain palpitation shortness of breath GI or any urinary symptoms.  Cancer care Associates note reviewed, recently restarted her chemotherapy after progression of her disease.   In emergency department, patient's vital signs are stable.  Given her concern for stroke, P1 CT imaging performed in the ED which showed stable brain metastasis with no new intracranial abnormalities.  Labs showed stable blood sugar levels.  Hospitalist team were consulted for further management of her symptoms.
All at injection site area: pain, swelling, hardness, red and very warm to the touch.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 28-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-009507513:
patients rt arm became swollen, red, hot, and painful Tues night after getting the fluzone HD. Symptoms did not subside by Wed night so patient was seen and prescribed keflex
near black outs when sitting or standing (not lying down); Shortness of breath with little activity; elevated heart rate after little activity (eating breakfast, washing dishes, etc.); fuzzy vision; dizziness; headaches when lying down.; heart racing; patient pregnant and received BNT162b2 vaccine; This is a spontaneous report from a contactable consumer. A 28-year-old pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 11May2021 16:00 (Batch/Lot number was not reported) at the age of 28 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL); triticum aestivum germ oil (WHEAT GERM OIL); rubus idaeus leaf (RASPBERRY LEAF); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 received by the patient on 19Apr2021 09:30 AM administered in the right arm intramuscularly, at the age of 28 years, as dose 1, single for COVID-19 immunization. On 12May2021 07:00 AM, the patient experienced shortness of breath with little activity, elevated heart rate after little activity (eating breakfast, washing dishes, etc.), fuzzy vision, dizziness, and near black outs when sitting or standing (not lying down), headaches when lying down. She also experienced heart racing on the same day (12May2021). There were no treatments for the events. The patient has no history of COVID-19 infection prior to vaccination and has not been tested for it post vaccination. The mother was 18 weeks pregnant at the onset of the event. The mother was due to deliver on 08Oct2021 as the patient LMP (last menstrual period) was 31Dec2020. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 2021. No apparent previous infection or expose prior to vaccination. Outcome of dizziness, heart racing, near blackouts, headache was recovered on an unspecified date, while outcome of the remaining events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Arrhythmia; Arrhythmia that cause Angina; Backache; Serious Diarrhea; Headache; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Arrhythmia) and ANGINA PECTORIS (Arrhythmia that cause Angina) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), ANGINA PECTORIS (Arrhythmia that cause Angina) (seriousness criterion medically significant), BACK PAIN (Backache), DIARRHOEA (Serious Diarrhea) and HEADACHE (Headache). At the time of the report, ARRHYTHMIA (Arrhythmia), ANGINA PECTORIS (Arrhythmia that cause Angina), BACK PAIN (Backache), DIARRHOEA (Serious Diarrhea) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Arrhythmia and unexpected, serious (Medically significant) event of Angina pectoris. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. There was no information provided regarding the initial two doses. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the events was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Arrhythmia and unexpected, serious (Medically significant) event of Angina pectoris. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. There was no information provided regarding the initial two doses. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the events was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.
1)  Approximately 16 hours after shot: nausea, vomiting (1 time), fainting (1 time), profuse sweating. These occurred together in one episode and did not recur 2) 16 hours after shot until about 36 hours after shot: fever, chills, muscle aches, fatigue 3) Beginning 1 or 2 days after shot, resolving about 3 weeks after shot: racing, pounding heart, feeling of chest pressure, periods of intermittent fast pulse occurring with light-headedness and fatigue. Did not change in response to physical exercise, time of day. Most frequent and intense for about the first 10 days after shot, lessening after that to resolving without treatment 3 weeks after shot
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-NOV-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Swollen lymph node in right armpit. Started close to the 24 hour mark after vaccine. Swollen to about the size of a prune.
Information has been received from a physician concerning an approximately 25 year old female patient with no known drug allergies or medical history reported, who on 26-MAR-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 mL dose of GARDASIL (Lot #0152X).  There was no concomitant medication.  On approximately 02-APR-2008, the patient developed pain, warmth and diffuse muscle tenderness in her left upper arm.  She was examined by the physician on 02-APR-2008 and prescribed corticosteroids (unspecified).  She was also examined on 08-APR-2008 and reported that her upper body was hot and sore and she was lethargic.  It was reported that there were no abnormal findings on physical exam other than mild injection site tenderness and no fever.  Diagnostic laboratory testing performed included blood tests with unknown results.  No product quality complaint was involved.  The reporting physician considered these events to be disabling/incapacitating.  Additional information has been requested.
FEVER; This spontaneous report received from a parent concerned a child of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.4 F, 102.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
The vaccine shot area was very sore and bruised from day 1. Muscle pain and limited movement started about a week later.  It has been sore and unable to move my left arm fully.  Can not fully extend arm over my head. It's like a very sore/tight muscle pain that I can not seem to get relief from, or improve. It started mostly around the shot area and moved up to my shoulder, and almost down to my elbow.  When I over extend, it is excruciatingly painful.
4-15-15/pain of shoulder and arm 8/10. 4-17-15/redness, warmth and swelling of arm-concern for cellulitis and treated with KEFLEX for 7 days and MOBIC for pain.
8/24/21 hx of HTN, HLD, hypothyroid, CVA, OSA, GERD, lumbar spinal stenosis, who presented to ED for evaluation of fever
This spontaneous case, initially received from a physician on 15-Nov-2018, concerning a male patient of an unspecified age (reported as 40-50 years of age). On 12-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252683, expiry date: not reported). On the same day, after vaccination, the patient contracted an eye infection and experienced localized swelling, redness and vertigo. The physician had monitored the infection and said that the infection 'seems to be better'. The physician confirmed that no treatment measures were associated with the events. The outcome of the events was resolved on 15-Nov-2018. At the time of this report, the patient was well. The reporter assessed the case as non-serious and considered the causality of the events as related to the suspect product.
Case number PHEH2013US0113520 is an initial spontaneous report received from a nurse on 21 Jun 2013, and with a follow up report receive on 16 Jul 2013. This report refers to a 12-month old patient of an unknown gender. The nurse reconstituted MMR vaccine powder (other manufacturer, batch number: unknown) with liquid component Men CYW-135 of MENVEO (batch number: unknown) and administered to a patient of an unspecified date. So the patient had received measles, mumps, rubella and three meningitis antigens. Nurse reported that it was unknown whether this occurred. No adverse event was reported following medication error. No further information was provided. Follow up report received from nurse on 16 Jul 2013. Updated narrative.
A month after the vaccine I developed a rash on my chest arms and hands. I went to my doctor which referred me to dermatology and they prescribed 3 different steroid creams. The creams help some but the rash didn't completely go away. I also developed a lump in the left side of my throat I have an appointment for an ultrasound on Wednesday. The lump has been here for the past two months.
Nose irritation and swelling, runny nose, Sneezing, coughing, headache, extremely tired and weak, chills, loss of appetite. Diarrhea.