chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in wrist / It felt broken; it still hurts in certain movements and is hard to hold or push things.; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; my muscle in my left shoulder blade are swollen.; I feel random pain at the injection site in my upper left arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 05May2021 (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history or known allergies. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06May2021 at 01:00 am, the patient experienced severe pain in wrist in the middle of the night after receiving vaccine. It felt broken. Although pain had dulled, it still hurts in certain movements and was hard to hold or push things. Her whole arm tingles as if a nerve was pinched. It was so uncomfortable, she did mention to a PCP who didn't do anything. The patient proceeded to see a chiropractor who noticed her muscle in her left shoulder blade were swollen. Even that day, 06Nov2021, the patient felt random pain at the injection site in her upper left arm. She has never had issues with her left arm or had anything ever similar happen. This all started in the middle of the night the night after the vaccine and hadn't gone away. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient went to the Chiropractor received treatment for the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test which included COVID-19 test (nasal swab): Negative on 14Sep2021. The device date was reported as 06Nov2021. The case was assessed as non-serious. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
fever 106 showing p/vax;parent's called 911, were taken to ER;
On the middle left side of my back I feel a painful radiating heat/burning with simultaneous pins and needles sensation.; On the middle left side of my back I feel a painful radiating heat/burning with simultaneous pins and needles sensation; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date and unknown if ongoing. On 09Mar2021 at 20:15, the patient experienced on the middle-left side of her back, the patient felt a painful radiating heat/burning with simultaneous pins and needles sensation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful radiating heat/burning with simultaneous pins and needles sensation were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pfizer Dose 1 2/8/21 (EN6201) Pfizer Dose 2 3/1/21 (EN6203) COVID Positive 1/4/22  1/4/22: Patient is an 87-year-old male with past medical history significant for type 2 diabetes, CKD, CAD s/p stent placement, hypertension, B12 deficiency, history of unprovoked PE in 2018 currently anticoagulated on Eliquis, recent COVID-19 infection, melanoma with metastatic disease to lungs.  The patient presents to the ED today via EMS from a facility with worsening shortness of breath.  Of note, the patient was admitted to the Hospital for 3 weeks due to COVID-19 pneumonia, he was discharged to a facility 1/3/2022 on 8 L of oxygen via nasal cannula.  The patient's HPI is difficult to obtain due to his significant hypoxia and fatigue. The patient is not able to answer questions appropriately during examination.  Of note, the patient follows with Dr. for the management of his metastatic melanoma.  The patient had a CT of his chest completed on 11/30/2021 and reviewed slight enlargement of the pulmonary nodule in the right middle lobe.  He was previously being treated with keytruda; however, it has been on hold for 2 months due to worsening performance while on keytruda.   Upon arrival to the ED patient's temperature is 99.3°, heart rate 88, respirations 39, pulse ox 91% on 15 L high-flow oxygen, blood pressure 117/58.  The patient was subsequently placed on BiPAP at 50% FiO2 to maintain O2 saturations greater than 90%.  Patient's laboratory findings are significant for sodium 130, chloride 93, a gap 18, glucose 205, BUN 38, creatinine 1.68, AST 64, WBC 12.71, hemoglobin 11.5, hematocrit 36.1.  The patient received 6 mg IV Decadron, DuoNeb x1, Levaquin 750 mg IV, 2 L IV normal saline in ED.  1/6/22: Discontinue routine blood checks  Discontinue glucometer and insulin  Continue with comfort measures  Follow-up with care coordination and hospice team about DC to skilled on hospice Other medications discontinued.
Local muscle soreness occurring 11/18 to now. No other side effects??swelling, redness, paresthesias, weakness.
Vaccines proceeded as expected.  About a month later, patient presented with eye drainage and was treated with eye ointment.  He did not get better, and developed a fever on 7/14/23.  He looked pale and unwell and was admitted to the hospital.  Workup revealed acute myelogenous leukemia with spread to the CSF.  Given the rapid prorgression to leukemia, parents requested that we report to VAERS in case there were any correlation between timing of vaccination and onset of his leukemia.
Information has been received from a licensed practical nurse concerning a 77 yr old male with hypertension, chronic obstructive pulmonary disease, anemia, gout and allergies to sulfamethoxazole (+) trimethoprim (Bactrim) and amoxicillin trihydrate (+) clavulanate potassium (Augmentin). On 01/31/2002 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 639396/0718L), in the deltoid. Concomitant therapy included furosemide sodium (Lasix (furosemide sodium)) (40mg) (qd), allopurinol (Allopurinol MSD) (300 mg) (qd), clonidine (0.1 mg bid) and colchicine (0.5) (bid), famotidine (Pepcid) (20mg) (bid), and theophylline (Thesol) (1 tablet) (qd). On 02/01/2002, the day following vaccination, the pt developed a rash, wheals, and itchy fluid-filled red streaks that were below the injection site, at the deltoid. It was reported that the rash was between the injection site and elbow. The pt was seen in the Dr.'s office on 02/08/2002, when the symptoms were still present. It was noted that at that time the pt reported that " he had a fever earlier." The pt was prescribed diphenhydramine hcl (Benadryl) and prednisone. On 02/15/2002 the pt was seen again at which time he felt better and the symptoms had resolved. Additional information has been requested.
Vaccine received Wednesday 12/23 about 12:15-12:30 pm and arm was sore after. On Thursday 12/24: Tired in the afternoon and increasing tiredness and feeling weak.  Evening brought on headache, chills, fever of 100.7 or higher and fast heart rate of about 100 when resting heart rate is usually 55-60.
Patient was Covid + on 10/29/2021. Patient received Moderna with 1st dose 012L20A on 02/08/2021 and 2nd 029L20A 03/09/2021.  Per ED Note:  History of Present Illness     71-year-old male past medical history significant for paroxysmal A. fib, HTN, newly diagnosed prostate cancer who is presenting to the emergency department from home via private vehicle for chief complaint of weakness and falls.  Patient states that over the past 24 hours he has been feeling weak and has had difficulties standing.  Patient states that he had a fall approximately 5 hours prior to arrival.  Patient states that he went from a seated to standing position and felt weak and fell.  Patient states that he has pain on the left side of his chest wall from the fall. Patient denies any  abdominal pain, vomiting, difficulty breathing, focal paresthesias or weakness, headache, dizziness, fevers or chills, URI symptoms,  change in bowel or bladder habits, leg pain or history of blood clots, or changes in medications. He denies any other modifying precipitating or relieving factors. ED Course/Medical Decision Making:     Evaluation, management, services and procedures as well as the key components of the patient's care described here were performed in the presence of the attending physician.  Clinical records were reviewed. Pulse oximetry interpreted by me: 90% on room air-abnormal.   Initial evaluation: 71-year-old male past medical history significant for paroxysmal A. fib, HTN, newly diagnosed prostate cancer who is presenting to the emergency department from home via private vehicle for chief complaint of weakness and falls.   Vitals are reviewed and significant for heart rate of 125, respiratory rate of 33 and a temperature of 103.3.  Patient was placed on 2 L nasal cannula and given Tylenol for the fever.   Patient was given 10 mg of Lopressor and ED sepsis diagnostic pathway was triggered.  30 cc/kg was held as patient has lower extremity edema and mild crackles on exam.   Labs: CBC shows no leukocytosis or severe anemia.  Blood chemistry is significant for sodium of 130.  Troponin is negative.  proBNP is 444.  Lactic acid is unremarkable.  Covid is positive.   Imaging:   CXR: Limited study due to low lung volumes. No definite evidence for acute cardiopulmonary disease.   XR 2 view: Bronchial thickening without consolidation   CT head: No evidence for acute intracranial abnormality. Advanced pan-sinus disease.   EKG interpreted by myself and attending physician and demonstrates: Rhythm: A. fib with RVR. Rate: 123. Intervals: QRS: 92, QT/QTc: 314/449. ST elevations: No acute elevations or depressions. T wave changes: T wave inversion aVR. No acute ischemic changes. Prior ECG: No significant change from EKG in October 2018.   Patient's CHADVAS score is low risk at this time and heparin was not started.  Imaging was reviewed and was grossly unremarkable.  EKG showed A. fib RVR and repeat EKG showed normal sinus rhythm at a rate of 78.
fever; chills; fatigue; nausea; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2015, the patient was inoculated with the ZOSTAVAX at a shopping center, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. In 2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
They've been vaccinated with the first dose more than 6 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist called to report that the patients were coming into her pharmacy to get the second dose of Shingrix and did not receive yet, which led to incomplete course of vaccination. The reporter wanted to know how to proceed.  At the time of the call the reporter did not had any patient demographics or vaccination information, because was just calling to know how to proceed in those cases. No further details were provided at the time of the call. The reporter did not consent to follow up. The HCP did not consent nor declined follow up, because was just searching for the Medical Information answer to enquiry.
Patient had onset of pain, Redness, swelling at injection site approx. 2 days post vacc. There is a large Knot at site. RD enlarged lymph nodes. No previous hx of vac reaction
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-JUN-2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of burning during injection in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown) that expired on 22 June 2012. During vaccination with TWINRIX, the subject experienced burning during injection, expired vaccine used and pharmaceutical product complaint. The healthcare professional reported the subject received a dose from this TWINRIX batch and complained of burning as it went in. The reporter was planning to return this lot as she suspected the symptoms may be related to this particular lot [pharmaceutical product complaint]. At the time of reporting the outcome of the burning during injection was unspecified. The healthcare professional reported another subject who experienced adverse events with this TWINRIX lot, please see case A1018366A for this report.
Acute loss of physical strength.  Approximately, 40-50%.   I have not recovered.
The patient is a 75 yr/o male with a history of COPD presents with multiple constitutional symptoms have been present over the past week since getting his second COVID-19 vaccination.  Patient states he has had fever and chills, generalized fatigue, body aches, increased sleepiness, and some burning with urination.  Patient states his wife took his blood pressure this morning and that it was abnormal prompting the visit to the ER.  The patient states all the symptoms started about a day after getting his second COVID-19 vaccination and have been persistent since that time.  He states that he has a longstanding history of shortness of breath due to his COPD but no worsening shortness of breath over the past week.  Patient denies any chest pain, nausea, vomiting, bowel issues.  Patient denies any headache, dizziness, vision changes.  Patient does wear corrective lenses.   Per Triage:  HOT Fatigue (wife states BP was 67/48 this AM at home, 2nd COVID vaccine 2/19) Fever (all week  since wednesday off/on)  Final diagnoses: AKI (acute kidney injury) (CMS/HCC) Elevated CK Body aches Fatigue, unspecified type Transient hypotension
Severe pain in arm at 5AM, nausea and very cold that I had to get up and put on my winter pajamas.  I took a Tylenol and went back to bed.  Woke up at 7AM, still the same now light chills, overall feel like I have a flu coming on.
Case number PHEH2014US021995, is an initial spontaneous report received from a nurse on 29 OCT 2014. This report refers to a male patient of unknown age. Patient was sick with a severe cole 2 weeks prior to receiving the vaccine. The patient received FLUVIRIN 2014/2015 (batch number: 1413401) intramuscular on 28 OCT 2014. Two hours after vaccination he stated that he was feeling a little bit better. He went to bed at 07:30 PM the day of vaccination and woke up at 08:00 AM, the next day, which was not usual for him. Final outcome of the events, seriousness and causality assessment was not reported. No further information was provided.   Following an internal review on 10 NOV 2014, of the information received on 29 OCT 2014 significant correction was done. The coding of the event "started to feel run down" was changed to tiredness.
Myalgia injection site pain/arm pain, chills Narrative:  Arm pain/soreness the evening of the vaccine, then later overnight began to have chills, body aches all over, and some nausea from the pain of the body aches. Chills are subsiding as she uses a warming blanket, body aches are lingering, nausea comes and goes. Took Tylenol PM OTC last night, this morning took some NyQuil and went back to bed, feels the NyQuil is helping.
(after re- start of therapy) pre-existing fatty liver disease worsened and worsened liver function labs; from kidneys down to tail bone, whole back seized up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 12Oct2023, outcome "unknown", described as "from kidneys down to tail bone, whole back seized up"; INFLUENZA (non-serious), outcome "unknown", described as "(after re- start of therapy) pre-existing fatty liver disease worsened and worsened liver function labs".  Additional information: It was reported that the patient received shot on 11Oct2023 and on 12Oct2023, has got this from kidneys down to tail bone, whole back seized up (as reported), she also wondered if any side effects were caused by the Covid vaccine. It was clarified that patient if this Covid vaccine causes flu symptoms similar to this, the back being seized up from kidneys down to tail bone.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
dizzy; vomited; nausea; chills; cold sweat; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VOMITING (vomited), NAUSEA (nausea), CHILLS (chills) and COLD SWEAT (cold sweat) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizzy), VOMITING (vomited), NAUSEA (nausea), CHILLS (chills), COLD SWEAT (cold sweat) and MYALGIA (muscle aches). On 27-Feb-2021, VOMITING (vomited) had resolved. On 28-Feb-2021, MYALGIA (muscle aches) had resolved. At the time of the report, DIZZINESS (dizzy), NAUSEA (nausea), CHILLS (chills) and COLD SWEAT (cold sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.