chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16-year old daughter received the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old daughter received the first dose of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old daughter received the first dose of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old daughter received the first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
11/14/2021: Went to urgent care with atrial fibrillation with rapid ventricular response. Given oral and IV diltiazem, aspirin, and potassium chloride. Resolved by 8:30 a.m.  Next day blood results back and a diagnosis of hypothyroidism. No history of it... ave been tested since 1998 on semi-regular basis and never had an elevated reading. In Dec of 2019 reading  2.51 and on 11/14/2021 reading 10.8. On levothyroxine.
ACUTE MYOCARDITIS; This spontaneous report was received from literature: Myocarditis Temporally Associated with COVID-19 Vaccination. Rosner et al.: Myocarditis after COVID-19 Vaccination. This report concerned a 28 year old male. The patient's height, and weight were not reported. The patient had no history of prior covid19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 (3-7 days post vaccination), the patient was hospitalized for acute myocarditis-like illness. The patient also experienced acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I. The patient was hemodynamically stable and had no pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. The patient hospitalized for 2 days and symptoms resolved by hospital discharge. Treatment medication included beta-blocker, unspecified anti-inflammatory medication, aspirin, angiotensin converting Enzyme-Inhibitor(ACE-I) and clopidogrel (2 doses, stopped on discharge). Laboratory data (dates unspecified) included: ANA (NR: not provided) Negative, Blood pressure (NR: not provided) 145/82 mmHg, Body temperature (NR: not provided) 37 C, C-reactive protein (NR: not provided) 1.3 mg/dL, Cardiac MRI (NR: not provided) LVEF-50% (no regional wall motion abnormalities), Cardiac troponin I (NR: not provided) mean peak = 15.77ng/mL, median peak = 12.01ng/mL, Chest X-ray (NR: not provided) No acute pulmonary disease, Coronary angiograph (NR: not provided) No evidence of CAD, Echocardiogram (NR: not provided) LVEF-50%, LVIDd-4.8cm, IVS-1.0cm, RWMA-Mild global HKN, Electrocardiogram ST-T change (NR: not provided) 1mm ST elevation in II, V5-V6, Erythrocyte sedimentation rate (NR: not provided) 8 mm/h, Heart rate (NR: not provided) 70 bpm, PCR (NR: not provided) Negative, Respiratory viral panel (NR: not provided) Testing not obtained, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and WBC (NR: not provided) 8.08 (unit not reported).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocarditis. This case was reported to the vaccine adverse event reporting system (VAERS) and the CDC. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210650174- covid-19 vaccine ad26.cov2.s-Acute Myocarditis, . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of 9 patients (demographics unknown). On 07-AUG-2014, the patients received improperly stored VARIVAX (Merck) (dose, lot number, expiration date and route were not provided). No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 12:23 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Narrative:  90 yo male died at hospital on 12/19/2021 after being sent back there from rehab facility where he was residing due to recovery from broken 4 ribs after a fall at home. Pt. was dehydrated and dx with pneumonia.  (No mention of covid infection). Pt had received covid vaccines on 1/12/21, 2/9/21 & 9/8/21. Pt's problem list: Iron deficiency 09/16/2021 Weight loss 09/02/2021 Osteoarthritis of knee 03/09/2021 Constipation 09/18/2020 Orthostatic hypotension 07/24/2019 Vitamin B12 deficiency (non anemic) 07/24/2019 HTN - Hypertension 04/29/2019 Low back pain 04/29/2019 Benign prostatic hypertrophy without outflow 04/29/2019 obstruction GERD - Gastro-esophageal reflux disease 04/29/2019 Hyperlipidemia 06/04/2018 Chronic kidney disease stage 3 06/04/2018 Hearing loss 06/04/2018 Cardiac arrhythmia 02/04/2016 Edema 11/19/2015 Hyperparathyroidism due to renal insufficiency 11/19/2015 Major Depressive Disorder, Recurrent Episode, 07/30/2019 Moderate Degree Malignant neoplasm of upper limb 11/05/2014  Vitamin D Deficiency 07/02/2014 Personal History of other Mental Disorders 07/24/2019 Other B-complex deficiencies 07/02/2014 Malignant neoplasm of larynx 07/24/2019 Other nonspecific findings of urine 10/27/2016 Lack of Housing 08/29/2016 This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
It was about 5PM Dec 25th, 2021. I just ate a lot and after that I was shivering and cold at night. I was shivering so bad at one point I couldn't hold my phone. The next morning, I felt horrible I decided to go into a walk-in clinic because I was having a hard time breathing so I thought it was pneumonia because I've had it years ago. I was tested for COVID, and the results came back positive on the 27th. I loss the taste and smell. My oxygen Sunday was 97 and today was 99.  At night I sweat a lot and I shiver.
Extreme fatigue, muscle aches -- these adverse events started in late afternoon and continued through most of the next day Chills & fever, neuropathic pain (electrical shock-like symptoms on underside of arms & in upper legs) -- these adverse events started after bedtime, continued throughout the night, and subsided by later the next morning. Neuropathic pain was particularly severe, awakening me every 1 to 2 hours, making it near impossible to sleep that night. Except for the neuropathic pain, the other symptoms did not surprise me; neuropathic pain was very alarming & unexpected.
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00422751). A contactable female consumer reported for herself. The patient of an unspecified age and race received PREVNAR 13 at single dose on an unspecified date for immunization. 3 hours after receiving the injection the patient experienced a very severe reaction and was extremely sick. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 68 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 29-JUL-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported). As a result of his receipt of zoster vaccine live (ZOSTAVAX), in November 2015, patient was caused to suffer shingles, including any and all of its sequelae.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. Patient is informed and believes and further alleges that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, patient suffered shingles and other related health complications. In addition, patient requires and will continue to require healthcare and services. Patient has incurred and will continue to incur medical and related expenses. Patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Patient's direct medical losses and costs include physician care, monitoring, and treatment. Patient has incurred and will continue to incur mental and physical pain and suffering.  The outcome of shingles was reported as not recovered/not resolved. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).     Shingles was considered to be disabling.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 12-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0187), at the age of 12, in right arm, on May 17, 2021, at 16:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had vomiting, onset May 19, 2021, with outcome of recovering. Therapeutic measures were taken as a result of vomiting. Additional Information: No results in death. Not life-threatening. No prolonged hospitalization. Not disabling/incapacitating. No congenital anomaly/birth defect. No other medical history. Facility where the most recent COVID-19 vaccine administered: Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient treatment received for the adverse event included Zofran. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. No further information expected.
It was reported, an adult male received Tripedia on 5/25/99. Reportedly on 5/27/99, he experienced chills and fever of 102F. Reportedly the fever has resolved. From additional information received on 6/17/99, additional patient, responsible physician and vaccine information was given. Follow up #1 (6/26/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (deleted medication error).
area swollen-red in color, warm to touch & firm to touch;pt c/o pain upon touching;pt states noticed redness/swelling around 9PM on 8JUL96;apply warm compresses to area q 30min x 15min
extremely severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extremely severe headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (extremely severe headache). At the time of the report, HEADACHE (extremely severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory failure on 2L, hypertension, multinodular goiter who presents to ED on 4/25/2021 with symptoms of progressive shortness of breath, dysphagia and neck pain.    Labs showed  elevated BNP of 3000 and a hemoglobin of 8.5.  Patient was incidentally positive for COVID-19 pneumonia
Information has been received from a health care professional concerning a patient who in November 1999 was vaccinated with one dose of varicella virus vaccine live. In May 2000 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. The patient's 2 brothers had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Started feeling symptoms on Saturday when I woke up. Continued to be extremely tired for 4 days, fever for two days (highest was 101.9), chills, whole body ached.  Was extremely fatigued walking from the bedroom to the kitchen or family room.  Woke up on the fifth day feeling better but doing too much brought back the fatigue.
High Fever, Rash, sick for months, loss of speech, loss of eye contact, loss of motor planning abilities.
on2/11/2021 upon administering the Moderna Covid vaccine, the syringe and needle came apart upon administration, with liquid spraying onto patient's arm, provider's hand. When provider went to withdraw syringe, needle stayed in patient's arm, separate from syringe, removed easily. Second dose was administered at same visit, but at 0.4 ml, rather than 0.5 ml (Provider thinking some went in before needle and syringe came apart. Patient was contacted on 3/8/21 and reported only mild arm soreness after the vaccination.  Information from Moderna regarding trials using various doses from 50 to 250mcg was provided to patient.
Resident short of breath approximately 10 minutes post vaccination. Staff noted that his baseline upon activity and transferring is generally shortness of breath. Resident wears 2L NC, O2 saturation was 92%, increased to NC to 4 Liters O2 saturation up to 96%.  170/80, heart rate 94, regular rhythm. Sent to hospital.
Hives and rash. Two weeks of prednisone treatment and allergy medication. Hives and rash still persisted after one month.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment information was provided by reporter.  Date of refrigeration was reported as 05-07-2021.   This case was linked to MOD-2021-365137 (Patient Link).
Very sick; Unexplained neurological symptoms; Menopause in my 30's after this one; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced sickness, neurological symptom and early menopause. On an unknown date, the outcome of the sickness and neurological symptom were unknown and the outcome of the early menopause was not recovered/not resolved.   It was unknown if the reporter considered the sickness, neurological symptom and early menopause to be related to Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got very sick after a booster of vaccine with unexplained neurological symptoms and went into menopause in her thirties after that vaccine. This case has been linked to US2021AMR214141 (husband's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214141:Same reporter, husband's case
Severe and prolonged pain. Ongoing Phys. Therapy. Pain medication. Steroid injection.
Patient had a positive COVID test on 2/14/2022 and expired on 2/23/2022.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The nurse reported that the patient received 1st and 2nd dose of GARDASIL (lot # not reported) intramuscularly 5 years ago on an unspecified dates. The patient came into the office on an unspecified date this year, 2013, and received the 3rd dose of GARDASIL (lot # not reported) intramuscularly. No adverse effect reported. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/31/2023 Discharge Date: 2/3/2023 PRESENTING PROBLEM: Diarrhea of presumed infectious origin  Elevated troponin  Nonspecific chest pain  COVID-19  HOSPITAL COURSE: Patient 86-year-old gentleman with past medical history significant for prostate cancer status post radiation complicated by hemorrhagic cystitis , presented to the emergency department on 01/31/2020 with chief complain of weakness and recurrent falls x3, with bilateral knee laceration.  Patient had symptoms of rhinorrhea and diarrhea for 6 weeks prior to current admission.  Associated symptoms of dry cough with chest pain and exertional dyspnea.  In the emergency department was noted have tachycardia, troponin was slightly elevated at 144, COVID-19 was positive.  EKG did not show any significant changes.  Cardiology was informed who recommended admission to internal medicine for continued care.   Post admission patient had an echo which showed a reduced ejection fraction of 39%.  Cardiology pursued stress echo which was done on 02/02/2023.  On the stress echo patient was noted to have no signs of MRI and an EF of 49%.  Blood pressures were controlled by starting patient on metoprolol XL 50 mg orally 3 times a day along with losartan 50 mg orally 2 times a day.   For his a flutter with RVR patient was loaded with 0.5 of binge followed by 0.25 mg. Patient converted to normal sinus rhythm.  Cardiology initially recommended digoxin 0.125 mg orally daily.  However given improved rate control with just metoprolol digoxin was discontinued.  Patient being started on Eliquis for a an elevated Chad Vasc 2 score of 3.   Patient did not require any directed therapy for COVID-19.  Remained stable on room air.  Discharge cautiously with recommendations to follow-up with PCP and Cardiology post discharge.
Day of shot erythema and swelling, shakes and chills.  Erythema and swelling in left arm, legs and elbow at night of shot injection.
This spontaneous report was received from a Registered nurse who was a 46 year old male patient. The patient's medical history included bacterial spinal meningitis and chickenpox (varicella). No drug allergy was reported. The patient historically had 4 or 5 doses of unspecified Hepatitis B vaccines (manufacturer unknown) on an unspecified dates, to all which he failed to seroconvert (case# 1503USA0068430). Approximately on an unknown date in August 2012, the patient as vaccinated with RECOMBIVAX HB first dose, (dose, route, indication and lot number were not specified). Then the patient had blood titers Hepatitis B surface antibodies drawn on 22-AUG-2012, which were negative. On 09-SEP-2012, which was about a month after the previous dose of RECOMBIVAX HB, nurse then received another dose of RECOMBIVAX HB (dose and route were not reproted) (lot # 1572AA with the expiration date of 26-MAY-2014) dose 2. Other suspect therapies included PROPECIA 1 mg split in to half (start date, route and frequency was not reported) (case #1503USA006842) and ZOCOR (dose, frequency, route were unspecified). The nurse's serostatus was unspecified after the second dose of RECOMBIVAX HB. Action taken with simvastatin and finasteride was continued. The outcome of event was unknown. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.