chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was hospitalized due to breakthrough infection. Patient received Moderna vaccine (3rd dose in series) on 03/06/2021. Patient was hospitalized from 01/22/22 - 01/28/22. Below is copied from discharge summary:   Hospital Course:   Pt. is a 78 y.o. female with PMHx of CAD s/p PCI RCA 2006, PAD s/p left fem-pop bypass then L AKA, HFpEF, chronic moderate pericardial effusion l2/2 cardiac amyloid, IDDM, HTN, HLD, COPD, current tobacco use, low functional status, wheelchair bound who presented to the hospital for SOB.   Acute on Chronic HFpEF exacerbation Resolve CXR w bilateral pulmonary edema  Echo 2D Nov 2021 EF 60-65%, bright and speckled due to infiltrative disease Pro BNP 4900 Continue BB Lasix 40 mg PO daily Home O2 requested and delivered.   COVID 19 infection Dx with COVD 19 on 1/20  Procalcitonin 0.08 and vitamin D low Replace vitamin D  O2 as needed  Continue symbicort BID  Albuterol PRN for rescue    Paroxysmal Afib Continue AC Eliquis and metoprolol for rate control EKG with sinus rhythm, occasional PAC and PVC, bifascular block RBBB/LAFB    Cardiomyopathy 2/2 AL Amyloidosis Large Chronic Pericardial Effusion in the setting follow up as an outpt    COPD not on home O2  No active wheezing Symbicort and Albuterol  O2 as needed   CAP s/p PCI of RCA 2006 No chest pain    PAD s/p left fem-pop bypass then L AKA No acute issues    Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
12/17/2020 20 MIN AFTER INJECTION, FELT ITCHY AND WELTS. MEDICAL STAFF ADMINISTERED TYLENOL AND BENADRYL.  12/20/2020 AFTER RASH AND HIVES DISAPPEARED,  WOKE UP TO JOINT AND MUSCLE PAIN ALL OVER. PINS AND NEEDLES, FELT LIKE ON FIRE.  *MISSED 2 DAYS OF WORK DUE TO ACHES
fever 102, severe chills, severe uscle aches, headache, eye pain, pain at injection site, rash at injection site
arm was a little sore; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of unspecified age received BNT162B2 (COVID vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the COVID vaccine and her arm was a little sore but that's all. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
>4 days fevers >101 with large violaceous/ red skin reactions and swelling legs at site of HIB (L leg) more than DAPT and Hep A (R leg).
This spontaneous report was received from a pharmacist refers to a 62 year old female patient with arthritis. On 06-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M041669 for prophylaxis.  Concomitant therapies included fluoxetine hydrochloride (PROZAC), estradiol, hydrocodone, clonazepam, diclofenac sodium (VOLTAREN) and promethazine hydrochloride(PHENERGAN). On 07-AUG-2017, 2 days after onset of therapy the patient developed a rash generalised. The outcome of rash generalised was reported as not recovered/not resolved.
GOT PERIOD AFTER VACCINATION; This spontaneous report received from a patient concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had been in menopause since 2018 and some other history about the patient was 9/11(09-SEP-2001) survivor and had cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient who was in menopause received janssen covid-19 vaccine and her period came two days after the vaccination and it lasted for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from patient in menopause and got period after receiving the janssen covid-19 vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210920831-Covid-19 vaccine ad26.cov2.s-Got period after vaccination. 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).
Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated redness at injection site.  Area of redness was oval shaped about 2 inches in length and 1" wide. No treatment was used. Area cleared within 2 days.
Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with doses of varicella virus vaccine live (Oka/Merck) (Lot#657944/1003U). On 21-AUG-2007 the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Patient completed COVID vaccination series on 02/15/2021. Tested positive for COVID on 04/05/2021 and is symptomatic. Patient is currently 27 weeks pregnant.
Information has been received from a registered nurse concerning a female nurse who was evidently not using gloves to administer Rotateq (no lot number provided). Subsequently the patient experienced diarrhea. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-408551 (Patient Link).
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old female patient who experienced swelling of entire upper arm, red injection site and tender injection site. At 3 year of age, the patient received the fourth dose on 8/9/2005. Indication for Prevnar was immunization. Product was administered on 8/9/2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy none. On 8/11/2005, the child developed a 3 inch area of redness (injection site erythema) and tenderness (injection site pain) at the injection site. The mother also reported that the child's entire upper arm was swollen (injection site swelling). By 8/15/2005, the event had resolved. This is one of three children from the same facility who developed an injection site reaction following receipt of Prevnar lot A56117B. See MCN HQWYE949616AUG05 and MCN HQWYE973917AUG05.
Client stated," I had a pain in my chest for less than a minute, about 15 minutes after I was vaccinated." The client denied experiencing shortness of breath, difficulty breathing or swallowing, changes in vision, lightheadedness, radiating or tingling sensation.
Prior to taking the Covid-19 Janssen vaccination, I  have had normal menstrual cycles since menstruation began at age 11. After receiving the shot on 10/5/ 21 menstrual cycle was expected between 10/13/2021 - 10/18/2021 and did no come.  Cycle still has yet to come, even though all typical symptoms revolving around cycle have occurred (menstrual cramps, face break out, etc). There is no pregnancy, medications, or use of birth control to affect this change.
FIRST DOSE OF HEPATITIS B WAS GIVEN TWICE. NO ADVERSE REACTIONS AT THIS TIME.
No adverse event.  Patient is under 18 years old and Moderna is not indicated for patients under 18.
4 days after receiving the Tdap vaccine in L deltoid, c/o pain in arm. The next AM, patient awoke with erythema and edema in upper/front left arm (not at injection site) plus warm to the touch. One week after receiving the Tdap, skin still red but no edema and less pain.
Narrative: Patient received a covid vaccine EUA (J&J) on 4/12/2021. Pt died on 10/10/2022. Pt recently had new diagnosis of acute on chronic heart failure (9/23/22) not included in his problem list yet. Pt had the following issues in medical chart problem list: Active Problems ---------------------------- 22 Active Problems PROBLEM LAST MOD PROVIDER Anemia (SCT 271737000) (ICD-10-CM D64.9) 06/15/2022 OA - Osteoarthritis of hip (SCT 239872002) 04/29/2022 (ICD-10-CM M16.9) History of gastrointestinal bleed (SCT 03/15/2022 275551007) (ICD-10-CM Z87.19), Onset 07/00/2016 Lumbar spinal stenosis (SCT 18347007) (ICD-10-CM 04/28/2021 M48.061) Proliferative retinopathy with retinal edema due 11/19/2020 to type 2 diabetes mellitus (SCT 97341000119105) (ICD-10-CM E11.3519) Chronic kidney disease stage 5 (SCT 433146000) (08/21/2020) (ICD-10-CM N18.5) Neck pain (SCT 81680005) (ICD-10-CM M54.12) 09/21/2018 Seen by palliative care service (SCT 441874000) 09/13/2018 (ICD-10-CM Z51.5) History of total knee arthroplasty (SCT 03/18/2019 1211000119105) (ICD-10-CM R69.), Onset 00/00/2016 1. Left 2016 2. Right 3/14/2019 Hyperparathyroidism due to renal insufficiency 08/09/2018 (SCT 19034001) (ICD-10-CM N25.81) Venous insufficiency of leg (SCT 234050002) 05/23/2018 (ICD-10-CM I87.2) Gout (SCT 90560007) (ICD-10-CM M10.9) 03/30/2018 Illicit due use (SCT 307052004) (ICD-10-CM 08/09/2017 R69). Marijuana Osteoarthritis of right knee joint (SCT 06/07/2017 323321000119100) (ICD-10-CM M17.11) H/O: rheumatoid arthritis (SCT 161567008) 06/07/2017 (ICD-10-CM M06.9) Coronary arteriosclerosis (SCT 53741008) 06/17/2017 (ICD-10-CM I25.10) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 11/17/2016 Cerebral infarction (SCT 432504007) (ICD-10-CM 11/17/2016 Z86.73) (ICD-10-CM N18.4); Chronic kidney disease stage 12/04/2017 4 due to hypertension (SNOMED CT 129151000119102) (ICD-10-CM M19.041); Osteoarthrosis of hand 04/05/2016 (SNOMED CT 22193007) (ICD-10-CM E11.65); Diabetic stage 3 chronic 01/12/2016 renal impairment due to type 2 diabetes mellitus (SNOMED CT 731000119105) (ICD-10-CM I10.); Benign hypertension (SNOMED CT 01/12/2016 10725009) Likely covid vaccine EUA (J&J) is not related to this pt's death given long length of time between date of vaccine & date of death.
tested positive for Covid; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. On 31Mar2021, after a week the patient got tested positive for covid virus. She was scheduled for 15Apr for the second dose appointment, but it is more than 21 days and she wondering if she should continue the second dose. She is under quarantine right now. On 31Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test was positive. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Arm swelled by injection shot, similar to a large lump, hot to touch and tender, size of tennis ball. next day the swelling went down a little, 3rd day it had spread from a swollen lump to a red welt and progressed lower on my upper left arm away from injection site. it is now a large red welt that is a rash. Also 3rd day woke up with a stuffy kind of ringing in ear, but it did go away later on that evening .
pt recvd MMR vax & exp t103 for 7 days; no further details were provided;
Presented with fever, some SOB; + Covid-19 in ED; admit to medical with Covid PNA; TX with Maxipime, remdesivir, vancomycin, Vit D3, steroids, zinc, LF O2; She will be discharged today to home.
After receiving the vaccine I noticed shortness of breath and now it has progressed to the fact I need oxygen 24/7 a day. Before this I was diagnosed with COPD, but I never needed oxygen until now.
Fever, redness & pain @ inject site for 3-4 days; 16NOV91 seizured @ home, ambulance to Hosp; airlifted to another hosp 16NOV91; remains in coma, ?encephalitis, didn't eat, c/o muscle aching 2 days a/sz; cultured H influenzae;
Tinnitus. Started after a few days of getting the vaccine. I was treated with  3 rounds of cisplatin in 2017 from October through December for squamous cell carcinoma. I did develop tinnitus at that time, but it completely resolved in a few months.
Administration at 2:00pm; At 2:15, patient complained of nausea and became diaphoretic.  He was placed in a supine position and provided a moist cloth for his forehead; vital signs and blood pressure remained stable.  He was provided a snack and dishcarge d to home at 2:50pm
Severe chest pain; jaw pain; could barely open my mouth; felt like someone sitting on my shoulders; I could barely walk; extreme fatigue; My arm was very sore; I had no energy and I was just dragging; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 13:15 (Lot number: FE3590) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 02Mar2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Feb2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "Severe chest pain"; PAIN IN JAW (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "jaw pain"; ORAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "could barely open my mouth"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "felt like someone sitting on my shoulders"; GAIT DISTURBANCE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I could barely walk"; FATIGUE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "My arm was very sore"; ASTHENIA (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I had no energy and I was just dragging". The events "severe chest pain", "jaw pain", "could barely open my mouth", "felt like someone sitting on my shoulders", "i could barely walk", "extreme fatigue", "my arm was very sore" and "i had no energy and i was just dragging" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, pain in jaw, oral discomfort, musculoskeletal discomfort, gait disturbance, fatigue, pain in extremity, asthenia. Additional Information: Patient did not received any treatment for AE. Patient did not tested Covid post vaccination. There was no Known allergies. Other medical history was N/A. Patient had Covid prior vaccination. Device timestamp was 14Feb2022.
First two day: Fever, headache, chills, nausea, dizziness, injection site pain  Next 14 days: Motion sickness when riding in cars and extreme headache (like an ice cream headache) when sitting for longer than 1 minute or standing longer than 3 minutes. Treatment was 800 mg Ibuprofen 3 times per day for 10 days, then 800 mg Ibuprofen twice per day for 4 days, then 800 mg Ibuprofen as needed.
About 16 hours after injection (woke up the next morning) with myalgias, headache, chills, fever to 100. Feeling flu like.
Received flu vaccine on 2/14/14. Went to Hosp ER on 2/15/14 due to large, red, swollen area on thigh. Treated with KEFLEX, increased in size returned to ER give KEFLEX and IV oral clindamycin. Improved - went to ER another dose.
4/3/2021: Hours after receiving vaccination patient reports experienced headache, nausea, sore/swollen arm,  redness at injection site.  4/4/2021: Arm has rash from injection site to approximately two inches above elbow; itchy/swollen
Bladder infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Bladder infection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concomitant products included CIPROFLOXACIN for Bladder infection, BENAZEPRIL, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CYSTITIS (Bladder infection). At the time of the report, CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included- Ciprofloxacin (for bladder infection).   This case was linked to US-MODERNATX, INC.-MOD-2021-101999 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: On 03-MAY-2021, a Follow up was received through Telephone Contact. It contained information about the second dose of suspect product and events associated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101999:second dose case
Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours.  Had Temp 100.3.  Headache, body aches, and no energy. Started feeling better on 4th day after Covid injection.
Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Dec2021 (Lot number: FL3197) at the age of 42 years as dose 3 (booster), single, intramuscular, administration date 12May2021 (Lot number: EW0176) as dose 2, single and intramuscular, administration date 21Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunization at Workplace clinic.The patient had no relevant medical history.The patient took concomitant medications included other medications the patient received within 2 weeks of vaccination: Centrum Men's Multivitamin. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 25Jan2022, outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: covid test name post vaccination: self test covid test type post vaccination: Nasal Swab; (25Jan2022) pending, notes: covid test name post vaccination: PCR covid test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.
Hives without respiratory involvement. Diphenhydramine 50 mg IM for treatment; Symptoms resolved; patient to home
feeling tired; She is a little bitty sore; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot/batch no: EL9232), dose 1 via an unspecified route of administration, administered in Arm Left (Injected in left arm unable to confirm if it is in the muscle) on 03Feb2021 (at the age of 73-years-old) as single dose for a COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was little bitty sore, and was feeling tired. She then said she was tired because she was shoveling snow. Her arm was not as sore as the flu shot. The patient did not report that she had a flu shot or not. The patient stated that the next dose they have indicated on the card was 22Feb2021, and it was her understanding she should have it 21 days after. On 22Feb2021, would be 19 days after today. It was 2 days earlier, and she wanted to know if that was significant. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Patient states 10 minutes after receiving her second, she started experiencing nausea, chest pain, light headedness. Patient was still in shot clinic facility waiting in observation. A nurse practitioner evaluated her and suspicious of atrial fibrillation, was directed to Medical Center ER via ambulance. Her PCP was notified by phone and he recommended same course of action. She was evaluated at the ER and patient states they didn't find anything wrong. Patient states that her PCP was already concerned about atrial fibrillation diagnosis and had referred her to cardiologist, but she has not had an eval yet in regards to atrial fibrillation.