chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider at Discharge: MD None Admission Date: 7/12/2022 Discharge Date:  7/18/2022  PRESENTING PROBLEM: Mucoid impaction of bronchi [T17.500A] Sepsis [A41.9] Cavitary lesion of lung [J98.4] Acute cystitis with hematuria [N30.01] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present [A41.9]   HOSPITAL COURSE: The patient is an 81-year-old male, with a history of BPH, who recently underwent a laser enucleation of the prostate on 07/06/2022.  The patient presented on 7/12 with fatigue and sepsis.  CT scan of the abdomen and pelvis showed cystitis and prostatitis as well as nonobstructive left-sided nephrolithiasis.  Urine and blood cultures were obtained in the ER and the patient was started on Zosyn.  Chest x-ray was performed showing a a right lower lobe infiltrate, and CT of the chest was performed revealing a cavitary lesion in the right lower lobe.  A review of prostate biopsies from 07/06 showed necrotizing granulomas.  Given the appearance of his cavitary lesion as well as necrotizing granulomas seen on prostate biopsy he was placed in negative isolation.  COVID testing was negative in the emergency room.  The patient was seen by Pulmonary, and underwent bronchoscopy on 07/13.  Findings at the time of bronchoscopy showed blackened endobronchial patches.  BAL was positive for COVID, and severe respiratory isolation was added to negative isolation.  BAL was also quickly positive for acid fast bacilli.  Sputum culture was positive for acid-fast bacilli on 07/14.  Both of these were identified as mycobacterium tuberculosis.  ID was consulted, and the patient was started on a 4 drug regimen of ethambutol, isoniazid, pyrazinamide and rifampin on 07/15.  The Health Department was contacted to assume management of the patient's active tuberculosis, with the patient being discharged to home on 07/18.   Current plan is for the DOT nurse to meet the patient at home at after discharge and coordinate DOTT TB treatment as well as testing of other family members.
did not receive 2nd Shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles outbreaks every 9 months). Previously administered products included Shingles vaccine (1st dose received on 31st March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd Shingles shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that they had regular shingles outbreak every 9 months, but had seen improvement in symptoms and severity since receiving first dose of Shingles shot. The reporter stated that they did not receive 2nd Shingles shot within 6 months of March when they got the first. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Pt is a know COPD and dementia who presented with severe sepsis with COVID pneumonia with acute respiratory failure. Pt is COVID + on 11/4/2021 at admission. Pt admitted with atrial fibrillation with RVR, SOB, elevated troponin, fever, COVID and acute chronic respiratory failure with hypoxia.  Treatment IV cardizem, Lovenox, IV Decadron, Breo inhaler, albuterol nebulizer, Metoprolol with chronic systolic congestive heart failure.  Pt required intubation, pressors, broad-spectrum IV antibiotics.  Patient developed acute kidney injury.  Patient Expired.
COVID Breakthrough Case  J&J Dose 6/8/21 (lot not listed in records) COVID Positive 11/7/21  11/7/21: Patient is 62-year-old male with past medical history of COPD, chronic hypoxic respiratory failure on 4 L oxygen at home, stage IIIB squamous cell carcinoma of the right lung on chemotherapy, pancytopenia, atrial fibrillation on chronic anticoagulation with Eliquis, hypertension, dyslipidemia, chronic hyponatremia, gout, ASD closure, paranoid schizophrenia, tobacco abuse, and obesity. He presented to the emergency room with complaint of shortness of breath. A few hours prior to presenting to the emergency room, patient had sudden onset of shortness of breath at rest. He also reported cough productive of greenish sputum. He also reported associated wheezing. He denied chest pain or palpitations. No fever chills or rigors. No sick contacts in the recent past. Patient is fully vaccinated for COVID-19. Patient still smokes up to 3 piece of cigarettes every day. No nausea vomiting or abdominal pain.  Upon evaluation at the emergency room, patient was in respiratory distress.  He was maintaining saturation with 4 L oxygen via nasal cannula which is his baseline. He was hemodynamically stable and afebrile. Significant lab findings are hyponatremia 131, hypokalemia at 3.3, hypomagnesemia at 1.2, troponin of 0.02 with repeat value at 0.02. CBC was remarkable for pancytopenia which is chronic. Absolute neutrophil count was at 1300. Platelet count was at 37000. Chest x-ray did not reveal any acute cardiopulmonary pathology.  At the emergency room, patient received an hour long DuoNeb nebulization, Solu-Medrol 125 mg IV, Levaquin 750 mg IV.  Potassium and magnesium on supplemented. Patient also received a unit of platelet.  11/12/21: Patient was admitted and underwent treatment for COVID 19 infection and COPD exacerbation  He was given IV abx, steroids, antiviral and bronchodilator therapies  Patient was very dissatisfied with his stay, complained about nursing staff not treating him right, "lying" to him about his compression stockings.  He was given neupogen for pancytopenia as well as PRBC and platelet transfusions. Oncology consulted and followed him, ok for discharge and f/u outpatient with Dr.   ID was consulted due to presence of pseudomonas in sputum culture, this likely is colinization however patient was continued on IV levaquin and will d/c with PO levaquin  Rate control medications were adjusted with favorable response  Patient was counceled extensively on RTC precautions, the importance to follow up with PCP , pulmonology, oncology, and ID as soon as he can make an appointment upon discharge  CBC, BMP on Monday, result to PCP and Dr.  Patient is at high risk of re-admission. He has been admitted at least once a month for the past several months  Patient cleared for discharge by specialty services involved  On the day of discharge patient states he will go home and smoke, despite my objection and discouragement. He states he doesn't want to "come back to hospital in 2 days" yet states he is ready to " get out of here"  Total time spent on d/c 50 minutes
Vaccine caused patient's blood sugar to drop, has been prescribed 2 additional blood sugar meds
hives, urticaria mostly over torso, face; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 15Dec2020 19:30 at a single dose for covid-19 immunization. The patient's medical history included persistent depressive disorder and known allergic reaction to wood varnish. The patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN). 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 and had not been tested for COVID-19 since the vaccination. The patient experienced hives, urticaria mostly over torso, face on 17Dec2020 18:00. Therapeutic measures were taken as a result of hives, urticaria mostly over torso, face and included treatment with dexamethasone. Outcome of the event was recovering.
Focal pain at injection site; chills/tremors; elevated body temperature; body aches; mechanical allodynia; neck/join pain and stiffness; substernal chest pain radiating to abdomen and right side of neck and jaw. All symptoms began to present approximate twelve hours after vaccine administration. As of 36 hours post-vaccination, symptoms have diminished, but not completely resolved.
Left lower quadrant abdominal pain. Diverticulitis of intestine with abscess and rupture treated with bowel rest and IV antibiotics, blood transfusion, 7 day hospital stay(12/6/21-12/12/21), and discharged home on antibiotics and follow-up care.
Patient describes rash, swelling, and tenderness at site of injection within the day after vaccination. Rash spread from injection site down approximately 2/3 of the way to the elbow. Patient also noticed some small bumps/pustules within the borders of the rash a couple of days after vaccination. Patient presented to pharmacy one week after vaccination, at which point rash was improved, but still visible and swelling gone.
fever & cold-like sx began 25JUN94 pt was given Septra sx did not improve; MD visit 5JUl94 & dx w/pneumonia, ear infections & flu; mom reported child's lt arm limp 8JUL94; on 9JUL94 visted hosp ER; spinal tap revealed meningitis;
Developed Hodgkins lymphoma. We diagnosed patient's cancer in August, 2008, and she is continuing chemotherapy. She will have a stem cell transplant too.  9/28/09 Hospital records received, multiple admissions and outpatient visits, DOS 8/22/09 to 9/09/09. Assessment: Hodgkin's Lymphoma stage II-A, bulky disease. Patient c/o "losing my voice'. (L) vocal cord paralysis. Dysphagia. Mediastinal mass. Chemotherapy. Fever. Neutropenia. Radiation therapy. Relapsed with positive B symptoms, mediastinal mass, neck and lung involvement. Cervical lymphadenopathy. Chemotherapy. Nausea, decreased appetite. Throat pain. Lung sounds diminished (R). Dry nonproductive cough and rhinorrhea. Stem cell harvest.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 29-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data, they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Patient presented with large swelling on the injection arm and edema in the posterior forearm (especially significant when compared to her right forearm). She had not tried anything 2 days out when she came to the store. It was recommended she call her doctor right away, and if the swelling/itching got any worse to visit the nearest ER or immediate care clinic for further treatment. She was advised to use an antihistamine such as BENADRYL or ZYRTEC (she reported no other medications). Upon follow-up the next day, the patient reported the itching/swelling had not gotten worse and seemed to be improving. Two days later she reported all symptoms were gone and she was back to normal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Jan2022 as dose 1, single (Batch/Lot number: unknown), in right arm and on 07Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-viral details: Product: Covid 19 Treatment. Brand was Paxlovid. Treatment start date was 06Jun2022. Treatment stop date was 10Jun2022. Lot number was FX4447. Indication was Treatment of Covid-19. Taking Paxlovid within a couple hours patient had a very bitter taste on the back of the tongue. Almost like tasting alum. This subsided within 6 - 8 hours, but re-occurs with the next dose taken. This sensation had increased over the course of the week's dosages. This adverse event started at 06Jun2022 at 09:30 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Employee stated that he pre-medicated with Ibuprofen/Tylenol prior to vaccine - He sated approximately 4 hours later that he had to take a 2nd dose as he felt that "his whole body was on fire" he also reported body aches, chills and extreme fatigue.  He is an ER provider. He had to go home early from his shift related to this feeling.
Myocarditis  Symptoms: CHEST PAIN, UNSPECIFIED(R079).  Patient presented for care early April with chest pain. However, he had chest pain that started approx. 1 week after vaccine. He is now under care with cardiology at . Pending diagnosis is myocarditis post 2nd dose of Moderna COVID Vaccine.
March Hallucinations, both visual and audio; April Hallucinations continue; May Hallucinations and trance-like behavior; June, Complete personality change. Hallucinations, withdrawal, fearfulness and sleeplessness; July same symptoms as above and she quit eating. August not eating or drinking without coercion, and then only small amounts August inability to start a urine stream; August sensitivity to sound; September continues all above symptoms.
Took vaccine and got shingles/suspected vaccination failure; Shingles; Very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took vaccine and got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's friend interactive digital media. The reporter stated that happened to his/her best friend.  The patient took the Shingles vaccine and two months later he had the shingles.  The patient said that it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
collar bone have been sore; armpit areas have been sore; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore). At the time of the report, LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains no significant information.
Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Pollen allergy, Allergy to animal dander and Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced LETHARGY (Lethargic). On 08-May-2021, LETHARGY (Lethargic) had resolved.            This case was linked to MOD-2021-076470 (Patient Link).
I received the Janssen vaccine on 3/5/2021.  My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period.  I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom.  There were clots in the blood in addition to extraordinarily heavy blood flow.  The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor.  I asked her to "run" all tests that were available and approved by insurance, which she did.  All came back normal.  Due to the significant difference in my period this month, the ARNP  requested an inner-uterine ultrasound which found the below:
Immediately post injection, I did not have any reactions.  Around 10 days after the shot, i woke up with a severally swollen site around the injection area. My arm was very sore and felt like a burning sensation. The redness/pain remained for 3-4 days after. The area was very sore, and made it difficult to sleep on that side.
Fever, Chills, chest congestion, tiredness, runny nose consecutively beginning about 4 to 4 1/2  hours post inoculation. Symptoms lasted 48 hours but at 60 hours, felt fine. Took NSAIDS and over the counter medication's to control symptoms. Did not seek professional medical advise or tele-health service.
began screaming uncontrollably the following day this cont x 3 days; mom said pt was not able to comfort pt at all; ran fever 101 or 102 R, poor appetite; pt has hx of frequent ear infect; did not see MD during this time;
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot number and injection site not reported). Subsequently the patient developed chickenpox. It was unknown if the patient sought any medical attention. The outcome was unspecified. This is one of several reports from the same source. Additional information has been requested.
Thigh numbness, 17 days after 2nd dose; Arm heaviness; Lower back pain on and off,; hip soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date the patient experienced thigh numbness. On an unknown date 17 days after 2nd dose vaccination, the patient experienced arm heaviness, lower back pain on and off and hip soreness. The clinical outcome of the events thigh numbness, arm heaviness, lower back pain on and off and hip soreness was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have a condition called cluster headaches ever since I was 8 years old and they come and go every 6 years meaning a cluster headache free period 5 years in between. I had my last cluster before the vaccines back in 2017 and right after getting the second shot, in 10 days, my episodes started and lasted roughly 40-45 days(the duration was regular for me). Cluster headaches is a rare condition, and often doctors misdiagnose and it takes years for patient to get an accurate diagnosis
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M041085, expiration date on 03-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the unspecifie temperature excursion. Data logger was involved in recording of the temperature excursions. There were unspecified previous excursions reported. Properly stored doses of sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported) were used to reconstitute the doses of the vaccine. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA006767:
Headache, Fatigue, Dizziness, Loss of Appetite, Shortness of breath
There was no adverse reaction but the nurse who administered the vaccine failed to realize that the second dose booster was given 2 weeks early. Patient was called and educated as to the situation.
it was rpt fr HCP concerning pt who was vax & subsequently exp muscle weakness, difficult swallowing & a varicella like rash on arms. addl info requested.