chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient arrived at shot table in TCPH w/c, short of breath. Taken straight back to private observation from shot table. EMT on site in attendance. Upon assessment; patient having suprasternal, substernal, intercostal retractions. Patient on home O2 at 2 L/M per NC. Per EMT auscultation patient has inspiratory and expiratory wheezing. Patient has a loose congested cough. Pt's nail beds dusky, no blanching. Hands are cold. Unable to initially obtain O2 sat reading. Patient does not have inhalers with her. Pt. can't recall names of meds.  9:30 BP 132/62; HR 68 strong and regular per palpation. RR 30.  9:40 O2 sat 82% after hands warmed. Patient increased her own O2 to 3 L/m . EMS activated  9:45 O2 sat 84% with 3 L/m per NC. Still having deep retractions.  9:50 EMS arrived along with FWFD. Patient alert/oriented x 4, still labored breathing. Patient denies feeling badly. Med star team evaluating.  0957 O2 97% on 3 l/m per nc. HR 72; BP 104/58; ETCO2 41 1007 O2 97% on 3 L/m per NC; ETCO2 43; HR 112; BP 96/56. EMS recommends transport. Patient refused. Pt. states she will go home and take her own nebulizer treatment. Patient called brother for ride Patient left AMA, patient remains A/O x 4, taken via w/c to brother's car for transport home.
Mom stated pt ran a fever, got sick, cried for hrs; leg swelled & his whole rt side turned red from hip to toes; Had a fever for 2 days & was red & swollen & very irrtable x 3 days afterwards;
- Weird sensation - passing out feeling.  - Right jaw upper lip swollen - numb, tingly - face was red used eye pack, took BENADRYL.
this is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a nurse practitioner concerning a 8 week old female infant with no known allergies or pertinent medical history who an unspecified date was vaccinated orally with 2ml of ROTATEQ (Oka/Merck) (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one of several reports the same source. Follow-up information has been recovered from a nurse practitioner concerning this 8 week old female infant with no known allergies or pertinent medical history who on 21-JUN-2008 was vaccinated orally in the PM with a first dose of ROTATEQ vaccine (Lot # 660596/0122X) (previously reported as lot # 660679/0407X). There was no illness at the time of vaccination. Subsequently since 23-JUN-2008 in the PM, the patient has 4-6 watery stools per day. On 26-JUN-2008 the family called the office. There were no lab studies performed. At the time of the report, the patient recovered after 4-5 days on approximately 27-JUN-2008. It was reported that the diarrhea resolved without treatment. Additional information is not expected. The patiet's twin brother also has an adverse event after vaccination with ROTATEQ vaccine (WAES 086USA0924). This is on of several reports from the same source.
Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm  is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch.  The other symptoms resolved after 24 hours.
Patient reported dizziness / lightheadedness after receiving the vaccine through today, 10/28/2019
Injection site soreness, numbness and burning sensation throughout the vaccinated arm extending to finger tips, swollen axillary lymph nodes. Patient did not experience these adverse effects for first nor second dose.
pt recv vax 24FEB90 & 24FEB90 exp h/a in back of head & above eyes, malaise, nausea, stiff neck &  abd cramps; WBC 10,800 w/a viral shift; pt had flu; anti-HBs neg;
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 18Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for Covid-19 immunisation. The patient's relevant medical history included: "Viral (non-Covid) pericarditis", start date: Nov2021 (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN, stop date: 18Apr2022; ALLOPURINOL; VYTORIN, stop date: 18Apr2022; COLCHICINE, stop date: 18Apr2022; ASPIRIN LOW; VITAMIN C [CALCIUM ASCORBATE], stop date: 18Apr2022; GLUCOSAMINE, stop date: 18Apr2022; VITAMIN B-12; CENTRUM, stop date: 18Apr2022. Past drug history included: Known allergies: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 18Apr2022, outcome "recovered with sequelae" and all described as "Report with Pfizer BioNTech Vaccine administered(patient also took Paxlovid for Covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Apr2022) Negative; (23Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course included: Covid symptoms and positive rapid test resumed 1 day after completing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
My arm has been in incredible pain ever since I got the flu shot. It hurts all the time, and nothing helps!! I take Advil, etc., and nothing helps. I have never had pain like this before from a vaccination. It is so upsetting. It hurts so much!!
Pt reports being in USOH, afebrile. Received vaccine with no acute sx. Awoke evening post shot with T102 F, painful oral sores, myalgias diffusely, and asthma exacerbation. SaO2 89%. Pt self-treated with prednisone course x 5 days with some improvement, with residual oral sores present 1 week following, temperature lasting 3 days, and partial improvement of asthma sx (still coughing nightly). Pt with very similar symptoms aggressively evaluated while on Fasenra with elevated inflammatory markers, however pt subsequently tolerated Dupixent and presently Nucala.
Information has been received from a physician who reported that a dentist mentioned to him a female patient on an unspecified date was vaccinated with a dose of GARDASIL. On an unspecified date after vaccination the patient had mouth and vulva ulcerations. The outcome was not reported. It was unspecified if the patient sought medical attention. This is one of two reports from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Within 6 hours of vaccine administration, patient became very ill with decreased appetite, headache and diarrhea that lasted 3 days.
This is a breakthrough case of COVID-19 that resulted in death.   The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/22/2021.   The individual tested positive via PCR for COVID-19 on 09/18/2021 and was admitted to the hospital on that same day. The individual reported COVID-19 symptoms of fatigue, weakness, cough, shortness of breath, fever, chills, nausea, vomiting, diarrhea, and feeling lightheaded. They were hospitalized until their death on 10/04/2021.   Death Certificate details are as follows:  Part I Cause of Death A: Acute Respiratory Distress Syndrome B: COVID 19 Pneumonia Part II Other Significant Conditions: Viral Sepsis, Shock, Immunosuppression, Acute Kidney Failure ON Chronic Kidney Disease, Hospital Acquired Pneumonia  The patient was considered to be immunosuppressed at the time of death, due to medication use; the person was a kidney transplant recipient.
leg cramps/cramp cause because it is harder to get in and out now; rotator cuff; back problems; it is hard to get in and out now; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing allergies (are acting up), ongoing sinuses is really draining a lot. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergy and sinuses. The patient previously took levocetirizine dihydrochloride (XYZAL) and experienced headaches, jittery and no sleep. She stated that she got her Pfizer shot and the next day stated that she had leg cramps and took some highlands leg cramp and than 2 hours later she had another leg cramp. she also has a cramp cause because it is harder to get in and out now. She has rotator cuff and back problems. She later stated that she is home bound. The outcome of events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
No additional AE; Medical assistant reported VAQTA was administered after temperature excursion.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 14-AUG-2023, the patient was vaccinated with a improperly stored hepatitis a vaccine, inactivated (VAQTA), intramuscular injection, 1 dose, lot # Y3ME2, expiration date: 23-FEB-2025, (strength, exact dose, dose#, and route of administration were not provided) for prophylaxis (product storage error). Lot Number Y3ME2 is not valid for a hepatitis a vaccine, inactivated (VAQTA), and does not match any Company product The operator of the device was a healthcare provider. No additional adverse event (no adverse event). For the suspect vaccine, temperature excursion was reported as 8.9 Celsius (C) degrees for 12 hours and 20 minutes on 14-AUG-2023, and 9.4 Celsius (C) degrees for 8 hours and 20 minutes on 28-SEP-2023. There was no previous temperature excursion reported.
Patient immediately developed markedly depressed anterior fontanelle which lasted 72 hours.  This was associated with irritability, but no fever.  Patient had no vomiting, no other neurological symptoms.
Patient came in for a  Moderna booster (.25) but received  full dose(.5)
Had unbelievable arthritis pain/ my flare; Hands and fingers were swollen; Had unbelievable arthritis pain/pain woke the patient up at night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at an dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. The concomitant medications were not reported. The patient previously took Xeljanz (XELJANZ) and experienced lack of efficacy and arthritis pain. The patient stated that she spoke with safety department yesterday. The patient has been taking Xeljanz for years. The patient retired recently and had to change her insurance. Starting 01Jul, the patient got 3 bottles of Xeljanz in the mail. After that first bottle and started the second bottle, it was like the patient was not taking any Xeljanz at all. The patient knew what that feels like because when she got the COVID vaccine, her doctor wanted her to pause Xeljanz and she had unbelievable arthritis pain. The patient's hands and fingers were swollen. The pain woke the patient up at night. The patient told her doctor about her flare and he told her double her prednisone dose. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant referring to a 24 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with a properly-stored dose of VARIVAX, reconstituted with a properly-stored diluent, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient had been receiving unspecified doses of certolizumab pegol (CIMZIA) for Crohn's disease. The reporter did not know whether the certolizumab pegol (CIMZIA) therapy was discontinued prior to the administration of VARIVAX, or when the last dose of certolizumab pegol (CIMZIA) was given. No adverse effect was reported. No product quality complaint was involved. Additional information is not expected since there was no consent to contact the reporter.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 22-Jun-2021 at 9:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 22-Jun-2021 at 9:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 58.67 for dose administered on 22-Jun-2021. No concomitant medications were reported. Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.
04/19/2022 Vaccination. 06/28/2022 I woke up with a headache and I was coughing but I do normally due to asthma. I thought bad allergies. Runny nose. I was sneezing a lot. After a few days, I was so fatigued I couldn't stay awake. I was traveling with my son. I took a home test and it was COVID positive. The symptoms appeared 5 days after I got to where I was traveling to so I am unsure if I got it there or who I was expose to. I was prescribed antibiotic what I thought was a bladder infection. My asthma is a little worse but it usually happens after I have anything respiratory in regards to infections and I thought COVID had set it off.
Pt recvd vax 26SEP92 & following vax SEP92 devel hives; pt treated w/Pred & DPH;
I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; Significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving.; This is a spontaneous report from a contactable consumer (patient herself).  A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 14:00 (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included obesity from an unknown date and while the knees were not in perfect health prior to the shot, patient was able to walk and hike, that patient had not been able to do at the time of report. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine and fluoxetine hydrochloride (PROZAC); both taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received first dose of BNT162B2 (Lot number: EL9264) via unspecified route on the left arm at age 37 years on 02Mar2021 at 08:30 AM for COVID-19 immunisation. On 24Mar2021 19:00, the patient experienced significant leg pain began in the right knee and then worsened, so that both legs were having difficulty moving. The doctor recommended Advil and electrolytes. It got a little bit better for a short time, but the pain is still there- I believe it triggered a pretty bad case of arthritis in both knees, and it is still a daily struggle. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the adverse event included cortisone shots so far, physical therapy, naproxen. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a Public Health Clinic. The outcome of the event was not recovered.   Further information has been requested.
On day 10 Post vaccination, patient developed increasing redness and swelling at site with a pustule in the center! Streaking note to axilla, Levaquin 750 mg PO daily x 5 days.
Rash began on back couple weeks after shot. Spread to chest. Used cream and took prednisone - rash went away. Once prednisone stopped, rash returns. It is currently as bad as it has been and extremely itchy. Had biopsy and diagnosed perivascular dermatitis.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Arm Red; felt not like herself; Arm Swollen; stay in bed for day and a half; feel tired; sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days), BEDRIDDEN (stay in bed for day and a half) and FATIGUE (feel tired). At the time of the report, ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen) and FATIGUE (feel tired) outcome was unknown and ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) had resolved.            Concomitant medications were not provided. Treatment information was not provided.  Symptoms onset date for all events was on JAN 2022 and stop date for Illness and bedridden on JAN 2022.
Patient is a 58 y.o. female with history of GERD,Hyperlipidemia,Hypertension,Nephrolithiasis,DM Type 2,DVT,Chronic pain syndrome,RA,OSA,COPD,Asthma,UTI,pneumonia, hypothyroidism, essential tremor presented to Hospital with Dizziness vomiting   Hypokalemia due to intractable vomiting . etiology unknown concern for gastritis gastroparesis in the setting of poorly controlled diabetes mellitus. Patient improved with potassium replacement, IV fluids, and antiemetics.   Covid-19 Virus Infection Date of onset of symptoms: 3 days prior to admission Symptoms present on admission: Nausea vomiting Date of covid positive test: 12/29/2022 Vaccination status: vaccinated Imaging: Chest x-ray shows no acute disease Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Anticipated special isolation end date: TBD   Intractable vomiting The patient also notes some diarrhea Stool PCR was negative Resolved with symptomatic treatment..   Hypertension Essential Continue losartan   Diabetes mellitus type 2, Blood glucose fairly controlled 95 on admission. Chronically uncontrolled given hemoglobin A1c of 9.4 1/31/22 Resume previous home diabetic regimen at discharge.   Chronic anemia. Continue to monitor and treat as needed.   DVT Continue Xarelto   Hypothyroidism Continue levothyroxine
Patient was brought to ER on 11/6/2021 due to severe weakness and lethargy. She was severly hypotensive with BP that could not be recorded, but she was also in Afib. She was given fluids and started on Zosyn for UTI/sepsis after urinalysis results were obtained. The patient continued to decline and the family decided to pursue comfort measures. The above adverse events may or may not be a result of the booster dose of vaccine, but per EUA provider is responsible to report serious adverse events irrespective of attribution to vaccination.
Started with aches and exhaustion around 10:30/11, progressed to a Fever for about 6 hours, chills for about 2 hours at 2:30am, followed by an hour of intense feelings of heat; Nausea for about 3 hours during chills, vomiting; all between 12am and 5:30am.