chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had very deep painful coughing. This lasted a long time and then I broke out in a fever, so I decided to go to the Emergency Room. After sitting in the Emergency Room for a very long time, I was admitted to the hospital for two days. While I was in the hospital, I was given antibiotics through an IV. The doctor diagnosed me with metapneumovirus, and he believed it tuned into a bacterial Bronchitis. I was also prescribed benzonatate, montelukast, guaifenesin, moxifloxacin, and albuterol. I am still dealing with these symptoms at this time.
The pt experienced edema, erythema, on the right arm. Treated with Benadryl.
Injection site pain; This is a spontaneous report received from a contactable consumer (patient). An unknown age female patient received BNT162B2 (COVID 19 vaccine) on an unspecific date at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Caller stated she has two questions, she received the Pfizer covid-19 vaccine on Saturday and she would like to know how long the injection site pain lasts. States she received the paper after the vaccine and wasn't asked if she was on blood thinners but she takes aspirin daily and hasn't been taking it because she was told to only take Tylenol. She took Tylenol because the injection site was painful. She is wondering if it's safe for her to take the aspirin. Caller states why would she answer any questions when she needs to speak to someone else about her questions, she is not in a bad situation, she is just curious. She would just like to know what would she be doing. Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Patient had Moderna vaccine on 8/12/2021 by Pharmacy. Patient had an appointment with our facility on 8/20/2021 for left leg pain that started the night before. He states it felt like a slight twinge that was more severe by his appointment. Was sent to the Emergency Room on 8/20/2021 and was diagnosed with left popliteal DVT. He was prescribed Eliquis and told to follow up with our facility 3 days later. Patient called on 8/25/2021 stating he felt worn out after moving around for a few minutes and needed to take breaks to catch his breath. Patient's doctor at our facility recommended him go the Emergency Room due to concern of pulmonary embolism. CTA on 8/25/2021 was positive for pulmonary emboli in the right lower lobe. The patient has no personal or family history of DVT.
This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 71-year-old male patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 29th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 30th May 2018, the patient experienced neck pain and movements reduced. The patient was treated with Physical Therapy (NOS) and Acupuncture. On an unknown date, the outcome of the neck pain and movements reduced were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the neck pain, injection site pain and movements reduced to be related to SHINGRIX. Additional details were provided as follows: The patient had some soreness at the injection site right after the dose, but it resolved after about 4 days. The caller reported that he had a lot of neck pain starting the day after receiving a dose of SHINGRIX. The patient had seen an orthopedist and had about 20 sessions of physical therapy, but he still had the neck pain. The patient was trying acupuncture at the time of reporting. The patient could not move his head to the full extent either right or left. The patient had a similar problem many years before the reporting date, but it did not last very long.
I had chills the first night after the vaccine. In addition to that I have continuous pain in the legs, feeling of dizziness and fatigue even after sound sleep in the night. I am having feeling of nausea and vomiting on a continuous basis which have not gone away even after four days have been complete since vaccination.
Patient stated morning after Moderna Vaccine 2, she developed a fever of 102F that lasted 17 hours. She also stated she had developed sharp shooting pains down her left arm and hip. In addition she had zapping in her muscles that rotated. She took Tylenol all day, and then advil that evening. Today, she is feeling better, just clammy.
don't feel right; getting dizzy spells; feel tired all the time; feeling really depressed and emotional; feeling really depressed and emotional; crying; stressful; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on 08Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 59-years) on an unknown date as dose 1, single for COVID-19 immunization and experienced slight heart palpitations that only lasted briefly and then she stated, but that could have been stress. After second dose first she felt great, she did not feel anything wrong at all. Then she reported around the beginning of May2021, she noticed that she just do not feel right, she was getting dizzy spells, she feel tired all the time. Patient feeling really depressed and emotional. During this report the she started crying. She stated that she just wanted to feel normal again. She was calling because her doctor advised her to call Pfizer or look on the website to see if anything similar has been reported regarding these emotional side effects. She stated that it was hard for her to know what was the true cause behind why she was feeling this way because she also opened her own business during this time and that has been really stressful as well, however, she stated that she just has not felt the same after receiving the second dose of the vaccine. She also mentioned it was hard to know what to believe about side effects with the Pfizer COVID-19 vaccine based on all of the different media reports. She also had a customer tell her that they have friends who have permanent seizures now because of the vaccine and she was unsure of what to believe. She was asking if these type of side effects (emotional) have been reported with the Pfizer COVID-19 vaccine. The clinical outcome of the events was reported as unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe
Lost his appetite; He thinks he got the shot very high in his arm; Arm was sore for a couple of days; Feeling down and has been resting in bed a lot; Feels weak; Chills; Muscle pain; A spontaneous report, was received from a consumer (patient), an 82-year-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced arm was sore for a couple of days (pain in extremity), loss of appetite (decreased appetite), feeling down and has been resting in bed a lot (depressed mood), feels weak (asthenia), chills, muscle pain (myalgia), and patient thinks he got the shot very high in his arm (product administered at inappropriate site).  The patient's medical history was not reported. Concomitant medications included insulin, dulaglutide, and unspecified statins for cholesterol.  On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned does of mRNA-1273 (Lot number: 013L20A), intramuscularly very high in arm for the prophylaxis of COVID-19 infection.  On the same day, the patient questioned the placement of his vaccination and reportedly thinks that he got the first dose of vaccine very high in his arm. Since the injection on 04 Feb 2021, the patient reported that his arm was sore for a couple of days, and loss of appetite for the last 8-10 days since 06 Feb 2021. The patient also experienced that he was feeling down in the last days and resting in bed a lot associated with chills, feels weak, and muscle pain since an unknown date in Feb 2021 after the Moderna vaccine. Treatment medication included was dextromethorphan hydrobromide; doxylamine succinate; ephedrine sulfate; ethanol; paracetamol which was given three times.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, arm was sore for a couple of days, loss of appetite, feeling down and has been resting in bed a lot, feels weak, chills, muscle pain, were not provided, and that of event patient thinks he got the shot very high in his arm, was recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for the event of vaccine administered at inappropriate site is assessed as Not Applicable.
This is a serious post-marketed study case from a physician in the USA who reports a patient experienced PERIORBITAL SWELLING after receiving FluMist. The reporter determined the events to be related to FluMist vaccination. On 12/05/04, a 15 year old male received FluMist intra-nasally and experienced nausea, dizziness, and periorbital edema within 20 minutes of vaccination, all considered medically important (OMIC). He was treated with 37.5mg Benadryl and monitored at the vaccination site. His vital signs remained stable and he never developed hypotension, respiratory distress, shortness of breath, upper airway obstruction, or wheeze. He was observed for 45 minutes until all symptoms resolved. Follow up the following day was unremarkable. The investigator determined the events to be related to FluMist vaccination.
fever of over 101 for 2 days, muscle aches and pains, nausea, difficulty breathing, wheezing, swollen arm at injection site and redness around the injection site.
Red Rashes; My Arm is Swollen; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient had no relevant medical history. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, when probed for concern, the patient stated that the arm was swollen and had red rashes and asked what can be done and this was after 2nd shot. The outcome of events was unknown.   No follow-up attempts are completed; information about batch/lot cannot be obtained.
About 5 mins p/shot got upset & c/o getting a shot; got pale, felt thirsty said felt sick, BP 84/46;
COVID19 Pfizer-BioNTech dose 1 administered as above (on 1/6/2021) COVID19 Pfizer-BioNTech dose 2 Lot #EL8982 on 1/26/2021  A 15 year old child of an employee received dose 1 and dose 2 as described with no medical adverse events, however outside of FDA EUA and State COVID-19 vaccine eligibility criteria.  administered vaccine to her child the first week of expanded access to vaccine beyond healthcare workers and other Tier 1a individuals.  On investigation, did not document these doses within the health or patient medical record systems, however did document the administration within the state vaccine tracking system.  On further investigation, stated that she administered the first dose of vaccine at the end of the day, when extra doses had been prepared and the employee stated that they did not want to waste a dose of vaccine.  During the hospital's investigation, a number of contributing factors were also identified, including three different electronic record systems and the need for manual entry of all vaccine administration into, in addition to one of the two other systems, as well as balancing prepared vaccine supply with demand.  These systematic gaps have been closed and through process change as well as electronic safeguards, future events will be prevented.
pt recv vax 26MAY98 & 27MAY98 pt devel fever 103, redness @ the inj site & a rash;pt was seen by MD;
This spontaneous report as received from a registered pharmacist refers to an approximately 69 years old female patient with penicillin, allergy to benzodiazepines, macrolides, metformin, codeine and quinolones. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on approximately 30-AUG-2010 "2 years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on unspecified date in 2012, the patient experienced shingles. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
I have it on my right heel plantar fasciitis; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 030M20A and 026A21A.) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis). At the time of the report, PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis) outcome was unknown.    Concomitant medications was not provided by the reporter.Treatment information was not provided. This case was linked to MOD-2021-408523, MOD-2021-408471, MOD-2021-408563 (Patient Link).
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with and improperly stored ZOSTAVAX VIAL 19400 PFU (plaque-forming units) (lot # L035286, expiry date 15-DEC-2016, dose and route of administration were not reported). It was reported that the vaccine underwent a temperature excursion of 35 degrees Fahrenheit for 8 hours. Administered with "2 or 3 doses with one patient receiving this week" (20-JUN-2016 - 24-JUN-2016) but would have only been exposed to prior excursion (35 degrees Fahrenheit for 12 hours) and not included current excursion. The vaccine underwent prior temperature excursion of 35 degrees Fahrenheit for 12 hours. There was no data logger. No adverse effects reported. The outcome of incorrect product storage and no adverse event were considered to be unknown. There was no Product Quality Complaint (PQC). Additional information has been requested.
Pt was admitted to hospital from the ED with acute cystitis without hematuria on 4/16/21, after receiving the second dose of vaccine on 4/5/21. Per guidelines, all hospitalizations are reported
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient got the booster shot found dead in the morning. Treatment drug was not reported.  Company comment: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death  (seriousness criteria death and medically significant) occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead in the morning. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-692839 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case regarding a male patient of an unknown age, with concurrent medical condition of diabetes, who died after receiving mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). The event Death  (seriousness criteria death and medically significant) occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. According to the report, patient received the booster shot and was found dead in the morning. No further details were disclosed. Concurrent medical condition of diabetes remains a confounding factor. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-692839:Master case; Reported Cause(s) of Death: unknown cause of death
Information has been received from a Registered Pharmacist/mother concerning a 24 month old patient, one of 2 cousins (the AE report for another included in the WAES # 1001USA03038) who on an unspecified date was vaccinated with one dose of VARIVAX (Merck). On 01-JAN-2010, two sisters, one of which was vaccinated with a dose of VARIVAX (Merck) on 12-DEC-2009 and one who developed chickenpox on 25-DEC-2009 (WAES 1001USA02546), were visiting family. 10-14 days after the family gathering 2 cousins, the patient, one of 2 cousins developed chicken pox with 50-100 lesions. The patient had not reached to age to receive their second dose. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received through the Merck pregnancy registry from a health professional concerning a female with a history of "2 full term deliveries and 1 previous pregnancy" with nausea who on 15-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654389/0961F). Concomitant therapy included PHENERGAN TABLETS/SUPPOSITORIES. On 19-FEB-2007 the patient received the second dose of Gardasil (Lot #653736/0014U) and on 19-JUN-2007 received a third dose of (Lot #657005/0314U). The patient found out she was pregnant, with a last menstrual period date of 09-APR-2007. On 27-JUN-2007 and 16-JUL-2007 (IUP 8 weeks 2 days), the patient had an ultrasound which confirmed the dates. The estimated date of deliver is 14-JAN-2008. Follow-up information was received from the physician. Concomitant therapy also included iron supplements. The estimated conception date was 02-JUN-2007, based on 16-JUL-2007 "us". On 16-DEC-2007 the patient had amniocentesis for suspected malformation lower extremities. On an unspecified date a fetal MRI was performed for screening of Pruder Willi, mytonic dystrophy and spinal muscular dystrophy; the results were negative. On 16-FEB-2008 the patient delivered a baby boy weighing 7 pounds and 15 ounces, 19 cm in length, head circumference of 14 mm with an Apgar score of 8/9. The baby was not born normal. The baby was born with club feet, congenital dislocation of the hip and malformation of the knees. On an unspecified date an amniotic fluid analysis was performed and was "PFP" within normal limits and a chromosomal analysis (karotype) was performed and the results were (L46, XY). The physician felt that club feet, congenital dislocation of the hip and malformation of the knees was a congenital anomaly. Additional information has been requested.
fever administered APAP @ 3PM, sl under dosed; 4PM sz, eyes rolled back, legs kicking seemed to last 2 minutes; when paramedics got there sz was over was pale & limp; taken to ER t99.8 R;
Information has been received from a health care professional concerning a patient who approximately "1 to 2 years ago" was vaccinated with 1 does of varicella virus vaccine live. On 04/20/2000 the patient developed breakthrough chickenpox with approximately 75 pox and no fever. The patient sought medical attention. Also reported was the patient's sister, one other sibling, and several other patients who were vaccinated and experienced similar events. Additional information has been requested.
This spontaneous report as received from a pharmacist via agency employee refers to some adult patients of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, anatomical location and expiration date were not reported). On an unknown date, the reporter's hospital decided to administered the PREVNAR to those patients, as they were not responding to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness between the event and the therapy with PNEUMOVAX 23 was not provided. Additional information is not expected, as the reporter was not willing for him/her or her/his doctor to be contacted to discuss further.
5 min after inhaleunt vaccine- Pt felt light headed - came to MD- caught as passed out - O2 SAT 99% HR 52- recheck 99% HR 106. (no breakfast/ + menses)
LEFT ARM HURTS AT THE SITE AND BELOW DOWN TO FOREARM - ACHING AND SORE TYPE PAIN AND THE MUSCLES FEEL TIGHT BELOW THE INJECTION SITE - WOKE UP AND HAD A HARD TIME MOVING ARM - TOOK ADVIL AND IT DIDN'T HELP SO SHE CAME BACK TO THE CLINIC.
PAIN IN THE RIGHT ARM THAT RADIATED, WHOLE BODY ACHE, TEMP 101, NAUSEA AND VOMITING, JOINTS (ELBOWS,ANKLES, SHOULDER, KNEE) BECAME SORE, HOT & SWEATY AND CALMY.
Pt admitted with c/o HA, Fatigue, Cough and muscle pain/weakness.  States had exposure to close contact that is Covid+.  Pt states is fully vaccinated and now with Covid19.