chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient ID: Age: 32 y.o. Admit Date: 8/13/2022  2:56 PM Discharge Date:  8/16/2022 Admitting Physician:  Discharge Physician:   Discharge Diagnosis: Principal Problem:   Acute renal failure with acute tubular necrosis superimposed on stage 3b chronic kidney disease Active Problems:   Type 1 diabetes mellitus with diabetic polyneuropathy   HTN (hypertension)   COVID-19 virus infection   Elevated d-dimer       HPI: "Patient is a 32 y.o. female who came to the ER due to persistent upper respiratory symptoms from Covid-19 infection. She tested (+) a week ago. She had been vaccinated. She has CKD 3b, HTN, DM. She is found to be in AKI with Cr 3.6. She has been admitted for that"   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.      * Acute renal failure with acute tubular necrosis superimposed on stage 3b chronic kidney disease o Acute on chronic renal failure. Serum creatinine remains elevated at 3.0 today but trending down closer to baseline near 2.0. Treated initially with IV fluids. Serum creatinine remained elevated and IV fluids held by nephrology. Improved as discussed above. Nephrology cleared for discharge to follow up outpatient.  o COVID-19 virus infection. Remains asymptomatic from respiratory standpoint. Not on any Remdesivir. Continue to monitor closely. o Diabetes mellitus type 1. Poorly controlled with a hemoglobin A1c of 10.2. Continue same treatment. Diabetic diet ordered. Insulin sliding scale. o Elevated d-dimer. Bumped from normal up to 1544. VQ scan was ordered. repeat d-dimer came back much lower at 346. V/Q scan resulted as low probability. Patient remains on room air with no respiratory symptoms. PE and DVT are unlikely. o Hypertension. Controlled. Continue same treatment. Follow up daily labs.      Physical Exam on the Date of Discharge: Stable and improved.
This spontaneous report as received from a coordinator Healthcare worker refers to specific patient of 61 year old of an unknown gender. None concurrent conditions or medical history were reported. On 16-MAR-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot No. K020802, expiration date: 31-JAN-2016), (route and anatomical location were not reported), which was improperly stored. No adverse effects were reported and no product quality complain (PQC) was filled. Additional information has been requested. This is one of several reports received from the same source.
Within a couple of hours of getting the vaccine, I had arm soreness, and redness developed on both upper arm areas. Redness went away by that evening, but I woke up the next day with a large swollen knot over the injection site area (about the size of a golf ball). I had a lot of arm soreness and pain throughout the day after getting the vaccine. All pain was gone By the following day (2/5/21- 2 days after vaccine shot)
Pt experienced tender and painful right upper arm the 2 day, post vax. Seen at clinic for monitoring/2 days in sequence by clinic MD's. Dx'd with possible hematoma or vaccine allergy. Pt was advised to use contrast packs 3-4 times a day.
itchy rash all over body; Red, itchy rash all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0510), via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: ER2631), via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced red, itchy rash all over body. No therapeutic measures were taken as a result of the adverse events. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red, itchy rash all over body was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
booster; sore arm for 4 days; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for Covid-19 immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm for 4 days".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient's guardian called after hours and spoke with on call provider. Mom reported hives on arms and stomach. Provider advised zyrtec and benadryl. No more reports by guardian has been made. Unable to reach guardian.
2 minutes after shot, I started sweating profusely, heart racing, difficulty breathing, tunnel vision and nausea.
Day 1 -5 (4/19- 4/23) -  Sore L-Upper Arm, Mild Headache, Fatigue Day 6 -7 (4/24 - 4/25) - Mild Constipation  Day 8-10 (4/26-4/28) - Mild Loose Stool 4/28 - 5/21 - Shortness of Breath, Dry Cough, Right side Pain, Swelling in Feet (more on Left Foot) 5/4 - Dr. visit 5/21 - Went to Emergency symptoms worsened
Develop chest tightness, mild SOB, lips and eyes are itchy. EPI PEN not administered - pt stated not severe. Sent to urgent care 1 mile away. BP 126/82, Pulse 65, Resp 16.
fevers from 101-104F and squeezing headache that started on 4/19/21.
69 y.o. female being admitted to the medical intensive care unit with new diagnosis of COVID pneumonia, septic shock in the setting of multiple medical problems   The history is obtained from speaking to Patient and her husband at the bedside.  The patient is a 68 year old female history of AS s/p TAVR, Afib on eliquis, OSA/OHS on CPAP, pulm HTN, COPD on 2L oxygen at baseline, DM, Adrenal insufficiency, complex LLE with multiple joint/hardware infections.     She was recently admitted here at Hospital from 09/09/2021 through 09/22/2021 for VRE hardware infection of left lower extremity requiring drain placement and antibiotics.  She presented to Medical Center on 9/9 with fevers and dyspnea. CXR noted pulmonary infiltrates. Patient found to be hypotensive thus given fluid resuscitation and started on norepinephrine. Cultures obtained and empiric abx added. She was transferred to the Intensive Care where she was quickly weaned off norepinephrine. She underwent CT imaging of the LLE showing new large fluid-density collection in the lateral thigh adjacent to the area of postsurgical change. IR consulted for drain placement on 09/11/2021, brown drainage noted and cultures  revealed vancomycin-resistant Enterococcus.  She was transitioned off NE and midodrine was started.  She was ultimately transferred to the hospitalist service.  Other issues during her hospital stay included atrial fibrillation with rapid ventricular response treated with beta-blockers and anticoagulation; troponin leak due to demand ischemia; new left bundle branch block; diastolic congestive heart failure, acute on chronic, with volume overload.  She required hydrocortisone for Addison's disease.  A drain was left in place to drain her complicated left lower extremity hardware for infection, with cultures ultimately growing VRE.  She was ultimately transitioned to chronic suppressive therapy with amoxicillin.     She presents to the emergency room today 10/25/2021 with shortness of breath and cough.  She is also experienced fever to 101 F, significant fatigue, loss of appetite, and diarrhea.  Her husband tells me symptoms have been present for about 1.5 weeks; about 2 weeks ago, she went camping and ?did fine?.  She was hypotensive with a blood pressure as low as 50s over 20s.  She has been started on norepinephrine and responds well to low-dose, currently at 0.02, although two efforts at weaning this off the emergency room have been unsuccessful, with rather abrupt drop in her blood pressure and associated worsening in her mentation.  Chest radiograph showed patchy bilateral airspace disease.  She tested positive for COVID.  She has been treated with empiric broad-spectrum antibiotics, including Zosyn, doxycycline, and vancomycin.   Patient is a fairly limited historian at this time due to clinical condition
01/08/2022: Event occurred after 2nd vaccine.  73-year-old with having diarrhea and black stools.  Is been going on for about several days now.  Was loose and dark black and brown.  She is not on blood thinners.  No nausea decreased oral intake.  No documented fevers or chills.  Is on oxygen normally.  she is got progressively more short of breath 01/11/2022: Dexamethasone 6 mg IV once daily  Remdesivir total 5 days Continue baricitinib. SpO2 91% 10L during my interview. Continue supplemental O2, wean SPO2> 90%.  Remains in hospital
Slight ringing in ears began 28 hours following receiving the vaccination, and the ringing is still present. The ringing is not bothersome, but a retired doctor friend suggested that I report this side effect. I am able to sleep soundly. This is the only possible side effect experienced following the 2nd dose.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HCT; METOPROLOL; TAMOXIFEN; TRAZODONE; LEVOTHYROXINE; ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. No known allergies. The patient took other medication in 2 weeks. COVID-19 treatment was Paxlovid from 05May2022 to 09May2022. 9 days after onset of COVID, patient had symptoms again. Symptoms of stuffy nose, cough, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FEEL COLD; HANDS AND HEAD ARE SWEATING; LIKE SOMEONE SITTING ON CHEST; FEELS LIKE GOT HIT BY A DAMN TRUCK; ARM HURTS LIKE HELL; HEADACHE ON AND OFF; FEVER; TIRED; BODY ACHES; BONES HURT; MOUTH HURTS; DIZZINESS / WOOZY; PRETTY EXTREME LIKE A BAD FLU/FEEL SICK; FEELS LIKE CLOGGED NOSE; HARD TO TAKE DEEP BREATH; WOKE UP IN MIDDLE OF NIGHT SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: No known medical history. The patient's grandfather died of aneurysm. Headaches come and go and really bad last night. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced bones hurt. On 02-NOV-2021, the patient experienced mouth hurts. On 02-NOV-2021, the patient experienced dizziness / woozy. On 02-NOV-2021, the patient experienced pretty extreme like a bad flu/feel sick. On 02-NOV-2021, the patient experienced feels like clogged nose. On 02-NOV-2021, the patient experienced hard to take deep breath. On 02-NOV-2021, the patient experienced woke up in middle of night sweating. On 02-NOV-2021, the patient experienced feels like got hit by a damn truck. On 02-NOV-2021, the patient experienced arm hurts like hell. On 02-NOV-2021, the patient experienced headache on and off. On 02-NOV-2021, the patient experienced fever. On 02-NOV-2021, the patient experienced tired. On 03-NOV-2021, the patient experienced hands and head are sweating. On 03-NOV-2021, the patient experienced like someone sitting on chest. On 03-NOV-2021, the patient experienced feel cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, tired, fever, bones hurt, mouth hurts, dizziness / woozy, arm hurts like hell, pretty extreme like a bad flu/feel sick, feels like clogged nose, hard to take deep breath, headache on and off, feel cold, hands and head are sweating, and like someone sitting on chest, and the outcome of woke up in middle of night sweating and feels like got hit by a damn truck was not reported. This report was non-serious.
The pt was vaccinated with Engerix-B at the same time as he was vaccinated with Havrix; 1 vaccine in each arm. On 3/27/00, the pt received his 1st dose of Havrix. On 3/29/00, he experienced a red and swollen rash from the armpit down body. An ER or doctor visit was required. The most recent information, received on 3/29/00, reports the condition of the vaccinee as unknown.
Immediate pain (muscle cramping)  at injection.  Pain continued all day. Took Tylenol 1 hour after injection: no relief. Relaxed all day. Continued throbbing at site. Placed arm in a sling because I was unable to  lift my arm and it gave me some relief. At supper I took t tramadol.  Still in throbbing pain when I went to bed. Slept well. Pain somewhat subsided but arm still unable to lift  in morning. Treated with chiropractic adjustment. More relief. Still  some soreness, but now able to life arm.
eight days after injection I got bad back back- lower lumbar, weakness and tingling in my legs and feet- called my Doctor, he said to take nati-inflamatories and possibly Prednisone if it gets worse.  I was injected on 11-11-21
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8727), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: EN6203) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Oct2021 as dose 2, single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2022 as dose 4 (booster), single (Lot number: 037A22B), in right arm and on 24Jan2023 as dose 5 (booster), single (Lot number: 042H22A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (09Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment for covid-19.
Injection site redness; Injection site swelling; Injection site pain on left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) and (batch number 45N3Y, expiry date 21st January 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   The patient's past medical history included drug allergy.   On 28th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 28th October 2019, the patient received Boostrix. On an unknown date, less than 5 months after receiving Shingrix and Boostrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix and Boostrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced an allergic reaction at injection site after dose one of Shingrix. The patient also received Boostrix on same date. The reporter described allergic reaction as injection site swelling, redness, and pain on left arm. The reporter consented to follow up.
chest pain began 5/28/2021. Presented to ER 5/29/2021 with elevated cardiac troponin 4.88. Echocardiogram revealed normal wall motion and no pericardial effusion. Cardiac MRI on 6/30/2021 reveals mild myocardial inflammation. Patient treated with ibuprofen and colchicine. Inflammatory markers remain elevated on 6/24/21 with continued use of antiinflammatories
The injection site is red, but not hurting; Up most of the night last night because of her headache.; bad headache; general body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache), MYALGIA (general body aches all over) and VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache) and MYALGIA (general body aches all over). On 26-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache), MYALGIA (general body aches all over) and VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment with Tylenol was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: TCR form is added.
Pt was queasy, blacked out, fell. Hit head on doorframe, comp. fract. of back, leg on doorframe. Called ambulance. Hospital wanted her to stay, she didn't.
Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose.   Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patients daughter-in-law, called me on 11-19-18 to report that after her father-in-law, received FLUAD on 10-14-18 from our pharmacy. He initially had a lot of redness and painful irritation at the injection site. She called us and we told her to put ice on it and use acetaminophen for the pain. She did that but it continued to hurt and the patient now had arm weakness in the vaccinated arm and can't raise his arm, hold a cup, or feed himself. His hand also shakes. Patient had an XRay done of his arm and it did not show any muscle damage. His health has also deteriorated since he had the flu shot-He not is having shortness of breath and is coughing up white and yellow phlegm. He now is having shortness of breath and is coughing up white and yellow phlegm. She is concerned since has never had a reaction to a flu shot before. She thinks the flu shot was given too high, close to his rotator cuff per daughter-in-law. She also thinks there was nerve damage from the flu shot that caused all these problems. Nurse told her this is very unusual to have this kind of reaction to a flu shot. She suggested she see a physician about the muscle weakness/breathing issues.
Swollen eyes, blotchy pink face.  Raised, bumpy Rash on both arms, very itchy.  Spread to torso and legs over the next 24 hours.  Taking Benadryl consistently, not giving much relief.
The pt experienced the following disorders after being vaccinated, autistic entercolitis, speech delay, mentally retarded, auditory processing disorder, auto immune disease, neurological damage, constipation, diarrhea, seizures, hypothyroidism, learning disability, high measles titers, and autism.