chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart rate is going quite up around 140; Having body ache; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In May2021, the patient was having body ache, fever and her heart rate is also going quite up around 140, so the reporter just wanted to check recommendation and asked if it was okay for her to take Tylenol with the vaccine? also added, "Are there any medications that are not supposed to be taken like Ibuprofen, Tylenol, paracetamol or something which she can take for her fever and body ache?" The outcome of the events was unknown.  Information about batch/lot number has been requested.
Patient arrives with a chief complaint of having a fall.  Patient fell at approximately 5:30 PM while working her way around her bed.  Patient was on the floor and her daughter noticed that she could not get a hold of her today and went over for a welfare check and found her still on the floor.  Patient says that she was just in too much pain and weak to get up.  Patient denies loss of consciousness.  Patient denies blood thinners.  There are multiple contusions.  Patient appears fairly comfortable on the cot, speaking in full sentences.  Patient has past surgical history of a hysterectomy and cardiac stent past medical history includes CAD diabetes and hypothyroid Patient is a non-smoker nondrinker   Associated Symptoms: back pain, fall, headache, injury, neck pain
Rash began on the left arm and spread to the right arm hours later. The next day the rash spread to my legs and neck.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: None relevant medical history reported.  No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a patient concerned a patient of unspecified age and 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 not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On MAR-2021, the subject experienced arm was little sore. On MAR-2021, the subject experienced mild headache. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was little sore, mild headache, and tired on 14-MAR-2021. This report was non-serious.
Myalgia and skin rash. Diphenhydramine 25 mg TID.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On 01-MAR-2014 the patient was vaccinated by staff error with a dose of PNEUMOVAX 23 (dose and route were not reported) lot number 0291AE expiry 25-JAN-2014. No adverse effect reported. Additional information is not expected.
1. Shortness of breath within 5 minutes of administration 2. Dizziness 3. Headache  Was administered and EpiPen and Acetaminophen
He developed a runny nose on Tuesday, April 4, 2023. He also had a cough that turned into a barking cough. He developed a fever as well. He was fighting the fever for a couple of days. I could tell me he was in pain. He was really fussy and cried all day and night. He didn't sleep or eat solid foods for a couple of days. He only wanted to breastfeed. He's getting better now, but he's still sick.
I start having SOB and fast heartbeat around the end of April.  It got worst through May.  I went to the ER They did blood work, that came back abnormal.  So, they did a CT scan, it show that a had pulmonary embolism, which confirmed that I had a blood clot.  The blood clot caused a strain on my right side of my heart.  I am not taking blood thinners.  I have never had blood clots before the vaccination.
09/15/2023: Head to toe hives, pruritic  for 2 days, detox discussed
Injection site got swollen; Injection site got red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site got swollen) and VACCINATION SITE ERYTHEMA (Injection site got red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site got swollen) and VACCINATION SITE ERYTHEMA (Injection site got red). At the time of the report, VACCINATION SITE SWELLING (Injection site got swollen) and VACCINATION SITE ERYTHEMA (Injection site got red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details were not provided.
Severe Itching Under Stomach/Hips/Legs; Severe Itching Under Stomach/Hips/Legs; Sleepless Nights For More Than 45 Days; Black Spots On The Legs. Like Chicken Pox.; This is a spontaneous report from a contactable consumer. This 58-year-old Female consumer (patient) reported. A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 (at the age of 58-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 22:00, the patient experienced severe itching under stomach/hips/legs. Sleepless nights for more than 45 days. Black spots on the legs like chicken pox. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Device time stamp was 04Aug2021. Information on the Lot/batch number has been requested.
No Wheal on first Intradermal administration. 2nd administration was successful subcutaneously.
Chest pains, heart pain, clenching feeling in heart that feels better when I sit up.
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008054 and expiration date 05-AUG-2016) (dose and route were not reported). No adverse effects were reported. No Product Quality Compliant (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Blood clots; Gangrene; Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine; patient was sent to rehabilitation center; surgery (a leg was amputated); two clots were removed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots), THROMBECTOMY (two clots were removed), GANGRENE (Gangrene) and LEG AMPUTATION (surgery (a leg was amputated)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (blood clots in heart and lungs for last 15 years) and Thrombectomy (40 clots removed from heart and lungs from past 15 years). Concurrent medical conditions included Systemic lupus erythematosus (bad lupus).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant). On 01-Mar-2021, the patient experienced THROMBECTOMY (two clots were removed) (seriousness criterion hospitalization prolonged) and LEG AMPUTATION (surgery (a leg was amputated)) (seriousness criterion hospitalization prolonged). On 12-Mar-2021, the patient experienced REHABILITATION THERAPY (patient was sent to rehabilitation center). On an unknown date, the patient experienced GANGRENE (Gangrene) (seriousness criterion hospitalization prolonged) and PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine). The patient was hospitalized on 10-Feb-2021 due to THROMBOSIS, then on 27-Feb-2021 due to LEG AMPUTATION and THROMBECTOMY. The patient was treated with Surgery for Gangrene. On 01-Mar-2021, THROMBECTOMY (two clots were removed) and LEG AMPUTATION (surgery (a leg was amputated)) had resolved. At the time of the report, THROMBOSIS (Blood clots), PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine) and REHABILITATION THERAPY (patient was sent to rehabilitation center) outcome was unknown and GANGRENE (Gangrene) had resolved.        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.   As per the patient's doctor, it was too late and dangerous to remove clots from the patient's leg and eventually, the doctor had to amputate the patient's leg because of gangrene.  No concomitant medications were reported.  Company comment: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.
patient reports systemic fatigue and body aches similar to influenza for 3 days, which subsided on their own. Localized red rash at vaccine site spreading down arm about 6 inches long and 2 inches wide on day 4. Patient advised to take diphenhydramine 50mg by mouth and monitor rash when presented on 5th day post-vaccine.
Mentioned wanting to kill himself; three voices in his head; Completely lost, he would not know who he was, where he was; Chest pain; Stomach pain; Hand pain/feet pain; Shaky feelings; Knee pain; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Mentioned wanting to kill himself) and HALLUCINATION, AUDITORY (three voices in his head) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hydrocephalus, Down's syndrome and Convulsions. Concomitant products included OXCARBAZEPINE (OXCARBAZEPIN) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SUICIDAL IDEATION (Mentioned wanting to kill himself) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (three voices in his head) (seriousness criterion medically significant), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, SUICIDAL IDEATION (Mentioned wanting to kill himself), HALLUCINATION, AUDITORY (three voices in his head), FEELING ABNORMAL (Completely lost, he would not know who he was, where he was), CHEST PAIN (Chest pain), ABDOMINAL PAIN UPPER (Stomach pain), PAIN IN EXTREMITY (Hand pain/feet pain), NERVOUSNESS (Shaky feelings), ARTHRALGIA (Knee pain) and MYALGIA (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Scan brain: normal (normal) normal.         Patient prescribed anxiety and sleeping pills that the physician did not recommend that he take.  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. Unlikely, that the events are related to the vaccine due to existing comorbidities.   This case was linked to MOD-2021-235268 (Patient Link).; 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. Unlikely, that the events are related to the vaccine due to existing comorbidities.
Patient tested positive while admitted.  Been admitted since 11/18/21.Complex medical history including chronic atrial fibrillation, hypertension, DM2, esophagitis with gastritis, gastric cancer with gastric outlet obstruction, cervical myelopathy, pseudogout, osteopenia, aspiration pneumonitis, urinary retention, admitted with nausea and vomiting, found to have gastric cancer with outlet obstruction.  A facility was consulted to assist with goals of care, now providing comfort-focused care at end of life
Urticaria, primarily on the abdomen, chest, and chest. Currently treating w/ Benadryl and Methylprednisolone.
At site of injection pt had developed enlarging area of circumferential erythema, edema and pain. No ulceration. Reaction developed 24 hrs post vaccination. Pt was tx'd for cellulitis.
ED visit for left leg pain and swelling - treated and released. Admission to the hospital with a left hemipelvic mass.  She underwent CT-guided drainage and fortunately the mass was found to be an abscess rather than a malignancy as we were originally concerned.  Drainage was uneventful and patient was placed on vancomycin and Zosyn. Treated and discharged. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
My symptoms began with a sore arm, then headache, cough, chills, high-grade fever, and sweating.
Hospitalization: 1/3/2023 - 1/4/2023 (30 hours) Presentation to the ED: substernal chest pain radiating to the back.  COVID + date: 1/3/2023 Treatment: no current indication for remdesivir or steroids.  Discharge to: Home.   011L20A 1/2/2021 012M20A 1/30/2021
Developed pain and swelling at injection site the evening of 2nd.  Upper arm became more swollen and painful over next 2 days; unable to lift arm due to tenderness;  erythema minimal
This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot number M035455, expiration date 22-APR-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursion were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001638 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1703USA013299: US-009507513-1704USA001638: US-009507513-1704USA001640.
Episode of palpitations and tachycardia to the 120s the night of my shot. Took my PRN Propanelol  20mg with resolution.  Arm soreness x2-3 days
10/18 - Vaccines administer. 10/19 - Patient with fever 101.2 degrees - 103.6 degrees F and crying. 10/19 - Patient visited hospital ED. No further workup - treated symptomatically. 10/20 - F/up with patient - improving - fever reduced. 10/21 - Onset of diarrhea.
Common, Pain at injection site.  Body, Muscle pain, slight headache. Not common (adverse) Swollen left lymph node. Not quite as bad as the swollen lymph node from my first covid shot (report #617152).
Myalgia, Arthralgia, Fever,  sore arm, abdominal muscle pain Narrative:  after receivng the 2nd dose, experienced shooting muscle pains in the  legs, low-grade temp and join pain in left hip (history of right hip replacement).  Experienced some abdominal muscle pain the day after. also experienced soreness in arm. Latter 2 issues noted as resolved.
Immediately after vaccination, I got heart palpitations. A minute or two later, I was quite dizzy. My husband said my pulse was 100 and irregular. The tech gave me ice water and I waited 15 minutes. When I left the store, I was still dizzy. My face was flushed. After I had been home about 10-15 minutes and the dizziness had gone, I took my bp. The first reading was 134/90, with pulse 84. Three more readings later, it was down to 118/86, pulse 76. The diastolic was still high but much better. I have had heart palpitations in the past but not with dizziness. I have never been diagnosed with high bp and my bp has always been normal at home.
redness and swelling at the injection site; redness and swelling at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She has treated with cold compress and Ibuprofen.No concomitant medications are provided.The outcome of the patient is  recovered.   Reporter did not allow further contact
the vaccine did not work as had this very bad flu disease; bout of flu; dehydration; high blood sugar; headache; diarrhea; chills; high fever of 103.5 f; Initial information was received on 01-Dec-2022 regarding an unsolicited valid  serious case received from a patient.  This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu with Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2022, the patient received 0.7 ml dose of suspect Influenza quadrival A-B high dose HV vaccine (with unknown strength, lot number and expiration date) via unknown route in the left arm for prophylactic vaccination.   On an unknown date in 2022, the patient had serious event the vaccine did not work as had this very bad flu disease (vaccination failure) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine. This event was assessed as medically significant. On an unknown date in 2022, the patient had non serious events bout of flu (influenza) wherein she experienced high blood sugar (blood glucose abnormal), dehydration, headache, diarrhea (diarrhoea), chills and high fever of 103.5 f (pyrexia) (latency: 6 weeks) following the administration of Influenza quadrival A-B high dose HV vaccine.  Relevant laboratory test results included: Blood glucose - On an unknown date: [high] Body temperature - On an unknown date: 103.5 F  Action taken: Not applicable.  Corrective treatment: The patient was treated with Paracetamol (Tylenol) for Influenza.  Outcome: Unknown for the events.; Sender's Comments: Sanofi company comment dated 06-Dec-2022: This case involves a 67 years old female patient and reporter reported that the vaccine did not work as had this very bad flu disease, and had bout of flu after being vaccinated with Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]. Case will be reevaluated post further update on concurrent condition during vaccination, past medical history, concomitant medications and risk factors underlying diseases excluding alternative etiologies for the reported events, which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
pt recv vax 21JUL97 & 22JUL97 pt was hosp w/fever of 101, dizziness, nausea, feeling hot & cold & an inj site rxn characterized by redness & warmth;pt recovered;