chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus headache; arm is a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore). At the time of the report, SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore) outcome was unknown. Not Provided          Patient stated, that patient did not make a report. Patient  did not have a sore arm or sinus headache No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant TCR received. Event details were updated.
Pain at inoculation site at vaccination. Development severe muscle pain R arm and  R shoulder within 4 hours. Self treatment with ice pack and sleep.   Pain 90% subsided within 48 hours.
This spontaneous report was received from a physician and other concerning a 2 year and 11 months old patient of unknown gender. On 21-NOV-2013, the patient was vaccinated with the second dose of M-M-R II (dose, route, lot number and expiration date not reported). Concomitant therapies included the second dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported) and the second dose of VAQTA (dose, route, lot number and expiration date not reported). No adverse events were reported. The other reporter mentioned that both VARIVAX (Merck) and VAQTA were given at appropriate times as second dose (interval from first doses ok). M-M-R II were given on 09-DEC-2011 and then on 21-NOV-2013 (at the age of 2 years and 11 months, which would be too early for booster dose (age 4-6). Additional information has been requested.
Patient is a 80 y.o. female patient of CNP with history of COPD A-fib CAD  presented to Hospital with shortness of breath now admitted for COPD exacerbation due to COVID infection.   Acute on chronic hypoxic respiratory failure Secondary to COVID infection Pneumonia due to COVID and pseudomonas Covid-19 Virus Infection Date of onset of symptoms: 8/26 Symptoms present on admission: SOB Date of covid positive test: 8/28 Vaccination status: vaccinated x 1, no booster Imaging: CXR with increased density in left lung, atelectasis vs infiltrate Oxygen requirements on admission: BIPAP Current oxygen requirements: 2L Medical therapy: steroids Consultants following: ID Anticipated special isolation end date: 9/5 Wears 2L at home came in initially needing BiPAP Chest x-ray with possible infiltrate Completed steroids  Breathing treatments Sputum cx grew pseudomonas-change antibiotic from ceftriaxone to cefepime on 9/2 Wean oxygen to home dose of 2-3L Positive D-dimer, CTPA neg for PE Much improved   Bradycardia Started on 8/31 - going into 40's and occ 30s Remdesivir started on 8/31 - can cause bradycardia Hold parameters on metoprolol S/p remdesivir, now stopped  Improved - maintained in the 50's or above Elevated troponin Likely demand ischemia from Afib and COVID infection Admission EKG-Afib RVR Troponin downtrending Denies any chest pain   A-fib RVR -now rate controlled Not on AC due to bleeding with Eliquis in the past Continue home metoprolol and diltiazem   Anemia- iron deficiency Baseline hb 12, admission hb 10.2 Hb 7.7 today -8/29/23 (?Dilutional) Cnt Home ferrous sulfate Transfuse if hb <7 Hemoglobin is stable.  Outpatient evaluation and management.   Hypertension, uncontrolled Home Cozaar Added amlodipine 9/1 Metoprolol already on board but occ held due to bradycardia   CAD Plavix, metoprolol, lipitor   Malnutrition BMI 17 Dietician consult
Patient had her first Gardasil shot on 02/15/2010. On 02/19/2010, she had a Grand Mal seizure. She had her 2nd shot on 08/06/2010. She died on 08/19/2010. Medical Examiner listed cause of death as Sudden unexpected death associated with Seizure Disorder.
After the administration of the Pfizer vaccine, the patient stated they felt warm and nauseous. The patient laid their head on the table and stated they were going to vomit. The patients blood pressure was taken and it was determined they were hypotensive so they were placed on the floor, where they then vomited. 911 was contacted and the patient was evaluated. After vomiting, the patients vitals stabilized and transport was refused to the hospital.
Information has been received from a pharmacist concerning her husband who on 04DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced pain at the injection site, which still persists today. The pt was not hospitalized. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint. Additional information has been requested.
received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received contains patient demographics and dose information.
Within an hour I became pale, lethargic, weak and dizzy which only lasted 2-3 hours. The next several days I developed extreme joint pain in all joints, similar to flu like joint pain, however I never became sick. Joint pain lasted 2 months. Developed daily headaches, brain fog that caused ADD like symptoms. Difficulty concentrating, speaking, reading, writing, poor memory retention.
1st dose 17Jan2022, 2nd not yet; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17-JAN-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 17Jan2022, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:04-APR-2023 The patient was scheduled for a heart procedure and the doctor did not want him/her to get the second dose until after the heart procedure.  The patient's doctor then went in for a hip replacement, and was not conducting office hours. The office manager did not call him/her when the doctor returned to her practice.  As lot of time has passed since shingrix 1st dose, the patient wanted to know if he/she had to do start all over with the first dose, or could he/she receive the second dose of the vaccine. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Migraine headache and malaise that started about 4 hours after the injection and has continued into today (10/26/18). I am pregnant.
In Oct90 10 out of 59 pts were found to have insuff or neg antibody levels during post serology testing for anti HBs.  (see EBU910168 - EBU910169 - EBU910171 - EBU910177)
Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pain radiating to base of skull and shoulders. Fatigue. Chills. Nausea. Headache.  Had repeat PCR Covid test at facility.  Negative. Naproxen for approx 10 days of no benefit. Heel pain, shoulder/neck pain, fatigue, chills, nausea and headache continued. Saw FNP BC March 8, 2021.  Symptoms continued through March 16.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and unknown gender. The patients medical history and current conditions were not reported. Since 03-JUN-2014, the unspecified number of patients were vaccinated with improperly stored ROTATEQ (dose/frequency, route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1407USA0009063, 1407USA012205, 1407USA012206, 1407USA012208. Additional information has been requested.
Back pain along spine and  headache started during the night (about 12 hours after vaccination). It was bad enough to keep me from sleeping. I started running a fever during the night as well. I got up around 5am because I could sleep with the pain , I took my temp it was about 101. I was also nauseas.  This lasted a few hours and was relieved with 600mg ibuprofen.  My arm has been painful the entire time (4days now).  Redness around the site has been getting larger. It started as just a small circle but after two days it started to grow to about 2?x4? and by today (day4) it covers my entire bicep and is starting to wrap around. It is also mildly itchy and swollen.  On the 31st I work up with a painfully swollen axillary lymph node on the left side. It stayed swollen and painful for about a day.
Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia  2. acute respiratory distress syndrome due to COVID 19  3. Acute heart failure with reduced ejection fraction  4. aspergillus pneumonia  5. history of prostate cancer, history hypertension
The vaccine did not prevent shingles as intended/and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles; contracted a persistent strain of herpes zoster also known as shingles and other complications/was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles. However the vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles (vaccination failure).  The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  The outcome of herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).    Additional information has been requested.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011701: US-009507513-1911USA011705: US-009507513-1911USA011706: 1911USA011703:
Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 30-36 hours.  My heart rate while sleeping was over 95+ bpm and 110-114bpm while awake  In addition, I had severe joint aches, fatigue, night sweats, fever for 48-72 hours.
The night that I got the vaccine, while I was asleep I started to develop a fever of 102.4F, chills, sweats, malaise. The symptoms persisted until I took ibuprofen and Benadryl so I could fall asleep and reduce my fever. I took ibuprofen throughout the day the next day along with DayQuil to ease my symptoms. The next night, I premedicated before bed with Theraflu and ibuprofen which allowed me to sleep. However I sweat through all my sheets and pillow. This morning I still had a fever and chills so I took more medication before I went into work and felt OK. I have now been without fever reducing medications for 16 hrs and my temperature is 99.9 F.
Tingling all over; hot and flushed. No treatments needed. Improved on its own approx. 10 min after it started.
Significant left arm pain at AC Joint, difficulty with mobility still (beginning day of vaccine). Swelling/fluid-like collection over left supraclavicular area, tender to the touch, beginning 1.28.21.
pt recvd vax & 10-15 sec later pt began to scream, abruptly hold breath, become pale & limp began circumoral cyanosis & 10 sec later w/tonic/clonic sz, eye rolling back; lasting 2-3mins pt apneic pos 3 mins;
Initially very mild tingling to nose and lips. Then in ED, BP 170s/110s. Then about 1 hour and 10-15 minutes later had rash start to pop up on random areas of my face. Then next morning with sore throat and rash around the next about 21-22 hours after the vaccine
NauseaVomiting malaise, fatigued, chills, and sweating (Staff member states,"No fever" Narrative:  Other Relevant History:
Joint soreness and stiffness in the shoulder and wrist in the arm that I received the vaccine. The wrist stiffness and soreness went away after a few days, however, the shoulder soreness and stiffness has been getting worse. I have not injured the shoulder and I am an active, fit 60 year old man that exercises several times per week. My shoulder soreness and stiffness is getting worse even though the injection was six months ago. I am confident this is the result of the injection because the soreness/stiffness started the day after the injection and has not subsided.
Myalgia; Fever; chills; A spontaneous report was received from a healthcare professional concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events myalgia, fever, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported. Reporter(physician) taking care of 2 patients who received moderna covid-19 vaccine and experienced same symptoms. On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving second dose of vaccine the patient experienced the event Myalgia, Fever, chills.Consumer provides consent for safety to contact for follow up  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, myalgia, fever, chills were unknown.
Received Moderna vaccine on 2/26. March 8, I broke into hives all over body. Took 2 Benadryl and hives subsided. March 9 6:30 am took 2 Benadryl again because felt slight itching. At 5:30 in the evening broke out in severe hives all over body again. Tongue started tingling also. Took 2 Benadryl. It's now 8:22pm and tongue still feels tingly hives have subsided but can still see faintly.
Left shoulder joint pain, headaches, stomach pain, severe left forearm nerve pain Physical Therapy, OTC Advil, Aleve, Tylenol, ASA, Also rest, ice, and elevation and exercises given from therapist daily. Outcome is progressing
The arm hurt after each shot a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The arm hurt after each shot a little bit) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), DILTIAZEM, PREDNISOLONE ACETATE, OFLOXACIN from an unknown date to 13-Sep-2021 and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (The arm hurt after each shot a little bit). At the time of the report, VACCINATION SITE PAIN (The arm hurt after each shot a little bit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided.   This case was linked to MOD-2021-320932, MOD-2021-320954 (Patient Link).
Pfizer Biotech COVID-19 mRNA given instead of Pfizer COVID-19 Bivalent.
Adverse effect of other bacterial vaccines, init encntr on 2015-10-20.
After going to bed last evening, experienced fast heart rate with pounding (as in heart beating) in head. Tachycardia continues, today with pounding in head.
Report A0371653A describes burning at the inject site in a PT (age, gender unspecified) who received Hep B vaccine recombinant (Engerix-B). This report was received from a nurse via a GSK sales rep. There was no relevant medical history, concurrent conditions, or concomitant medications provided. The vaccinee experienced no adverse events following receipt of the first injection of Engerix-B. On an unspecified date, the vaccinee received a 2nd injection of Engerix-B and immediately experienced burning at the inject site. The reaction did not last long and was reported to have resolved.
dizziness; fatigue; nausea; Pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 030A21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Acute lymphoblastic leukemia (In remission since 1996) in 1992, Alcohol use (4 drinks per week) from 2009 to 21-Jan-2021 and Marijuana use (1 gram per month) from 2008 to 21-Jan-2021. Concurrent medical conditions included Sulfonamide allergy and Migraine (Improvement since pregnancy) since 2007. Concomitant products included PRENATAL MULTIVITAMIN + DHA from 25-Jan-2021 to an unknown date for Prenatal care.   On 01-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (sore arm). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved. On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (Positive) positive. On 30-Jan-2021, Ultrasound scan: positive (Positive) positive pregnancy. On 16-Jun-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 29-Apr-2022, Ultrasound foetal: normal (normal) anatomy scan- normal, no findings.         On 01mar2021, post vaccination, the patient reported that she experienced symptoms of dizziness, fatigue, nausea, vaccination site pain and exposure during pregnancy.   No treatment information was provided  Internal review on 21jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Internal reviewon 21jul2021 resulted in updates to pregnancy information
I broke out in hives from mid chest to my scalp and I went to the emergency room and received an IV steroid.
moderate/severe headache: Oct 16, 8:00 am - 11:55 pm, resolved moderate body aches, soreness: Oct 16, 8:00 am - 11:55 pm, resolved moderate chills, tiredness: Oct 15 11:55pm - Oct 16 11:55pm, resolved moderate injection site pain: Oct 15 6:00 pm - Oct 19 11:55 pm, resolved bump under ear, possible swollen lymph nodes: Oct 18 5pm - present, haven't went away
Red, swollen area of upper thigh surrounding injection site for 10cm.  Diagnosis: Cellulitis.
Lymphocyte relative 13% low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis", start date: Jun2017 (ongoing), notes: ANA Positive. Concomitant medication(s) included: VUMERITY oral taken for multiple sclerosis (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: LYMPHOCYTE COUNT DECREASED (non-serious), outcome "unknown", described as "Lymphocyte relative 13% low". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient received dose 4 (gray cap) on 30Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Small blisters/rash over entire body, but more prominent on upper arms and chest- site near injection itches with multiple blisters present
pt recv vax SC on posterior arm 5inches above the elbow;area around inj site approx 4inches in diameter became red, warm, swollen & painful;had low grade fever (100.0 - 100.4) & h/a for 10 days p/vax;25NOV discolored around inj site