chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse reaction; hearingVaccination dates: 25-OCT-2017; 27-JUL-2019; 06-MAR-2020; 14-MAY-2020; This spontaneous report has been received from a lawyer and a 72-year-old male patient via a Plaintiff Fact Sheet. On 25-OCT-2017, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacture unknown) (strength, dose, route, lot #, expiration date were unknown) for prophylaxis. Then the patient also received the hepatitis b vaccine (recombinant)(manufacture unknown) vaccines on following dates: 27-JUL-2019; 06-MAR-2020 and 14-MAY-2020 (inappropriate schedule of product administration). There were no adverse reaction or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012802: US-009507513-2101USA012803:
Second dose received 0.25ml instead of 0.5ml; Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) and UNDERDOSE (Second dose received 0.25ml instead of 0.5ml) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). On an unknown date, the patient experienced UNDERDOSE (Second dose received 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) and UNDERDOSE (Second dose received 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 38 years and 1 month. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.  Vaccine NDC code was reported as 80777-0273-99. No treatment medication was provided.
I tested positive, diagnosis after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive, diagnosis after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive, diagnosis after vaccination). At the time of the report, COVID-19 (I tested positive, diagnosis after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive.         Concomitant medications were not provided by the reporter. Treatment information was not provided.
Received tdap vaccine on 6/26. On 6/30 I started with severe pain at the injection site. Next day the pain and swelling was from elbow to shoulder. By 7/2 the SJS symptoms started and progressed everyday. Rash, itching all over blisters in throat, hands and feet red and burning, tongue swollen, trouble breathing, fever (low grade) no temp control of my body. Went to dermatologist on 7/6 received cortisone shot. Returned 7/9 was put on steroids and ZYRTEC. Symptoms did not go away, so went to immunology and was put on stronger steroids finished on 8/13. Am still dealing with symptoms although not as severe. Currently waiting for blood test results and an appointment with ENT.
Immediate palpitation and shortness of breath upon second dose. One day after I went to the hospital for extreme palpitations, and slow heart rate under 59bpm. Very high anxiety since vaccination. Also headache and brain fog.
Soreness in chest muscles, I can breathe fine, taking deep breaths no problem.  When I cough or sneeze, my chest feels like I have been punched in chest..
parents stated pt had high pitch crying lasting several hrs; no fever; pt did have APAP; parents did call MD; they did not call clinic as recommended;
Narrative:  66yo male with Chronic left hemiplegia from prior CVA was placed in long term facility due to Self care deficit on Aug 12, 2021 and died at facility on 9/21/2021. No information relayed to agency regarding circumstances of pt's death. Pt had received covid vaccines on 4/8/21 & 5/18/21. Likely vaccines are unrelated to pt's death.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL that had been improperly stored (dose, route, lot # not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
13 days p/vax pt devel hives w/itching but no SOB or stridor;
After patient left, nurse realized that she administered 1.0 cc of vaccine instead of 0.5 cc of vaccine.  Pt was reached by telepone 3-8-10 - reported no adverse events.  Arm soreness was resolved within 24 hours of receiving vaccine.
experienced a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (experienced a burning sensation) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (experienced a burning sensation). At the time of the report, BURNING SENSATION (experienced a burning sensation) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Equate Saline Spray solution on a daily basis to rinse out her nose. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-jun-2021 and the case outcome was updated from unknown to recovered
I got the shot around/between 12 noon & 1pm, that night I had a slight fever but when I woke up the next day, my whole back felt so bad, worst on my lower back, I couldn't get up from bed.  I wasn't able to go to work.  Early evening of 11/03/2020, I took Ibuprofen to relieve the back pains but it lingered on especially the lower back.  It's a sharp pain, and very distinct.  Lower back pain lasted for about 2 weeks but up to this time I would still the sharp/distinct  pain most of the days but not as bad like in the beginning.  I have a co-worker, who had similar pains except but she didn't have the fever the way I did.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Mild
This spontaneous report was received from a physician refers to a female patient of an unknown age. Current conditions included Tourette Syndrome. On an unknown date the patient was vaccinated with dose of GARDASIL unspecified doses, route of administration not reported. No concomitant medications were reported. On an unknown date the patient was experiencing flare-up of her Tourettes Syndrome. The reported event did not resolve at the time of this report. Physician refused to provide additional information at the time of this report but she agreed to having follow-up forms sent to her. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/17/2022 Discharge Date: Jun 18, 2022  PRESENTING PROBLEM: Generalized weakness [R53.1] COVID [U07.1]   HOSPITAL COURSE: 91 year old male with history of HTN and asthma who presented to ER on 6/17/22 with complaints of fatigue. He tested positive for COVID in the ER. Fortunately, he had a total of four COVID vaccinations. He states he had breakfast with friends on Monday and felt fine. By Wednesday, he started with fatigue. He denies fever or SOB. He has history of asthma with chronic cough, which has been unchanged. He denies vomiting or diarrhea. He was feeling weak at home, but denies fall. While in the ER, he did desaturate to 88% with ambulation. This improved with rest and he remained off oxygen. He was monitored overnight and remained stable. He is independent in the room and anxious to return home. His wife would like him started on Paxloivid at discharge. Patient was instructed to remain in isolation for 5 days and mask in community for 5 additional days.
Arm soreness that got progressively worse with the passing hours. Soreness lasted about 48 hours.
patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.   No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  Total 40 number of vials/doses impacted. Treatment medications were not reported   This case was linked to MOD-2022-539812 (Patient Link).
Systemic: Pain and swelling at the left armpit-Mild, Additional Details: Patient stated swelling and pain at left armpit area since today morning (08/01/2021). The area is slowly migrated downward. She feels pain when pressing the area. Patient took Advil this morning, but no help on migration. Suggested to have a doctor visit tomorrow (08/02/21, Monday)
pain, swelling and redness at/near injection site for a week, fatigue, fever and overall body aches 3 to 5 days after injection
Associate gave the patient Moderna bivalent instead of Moderna Monovalent. She realized it after she gave the vaccine
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with ROTATEQ that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1403USA012181, 1404USA004081 and 1404USA004082 via same reporter link. Additional information has been requested.
Crying episode lasting 4-5 hrs per parents unable to console t101 that noc or the next day;
Reports that as the needle was going into his arm he started feeling light headed and nauseous. He reports that he doesn't do well with vaccinations. He believes that he started feeling this way before the vaccine was even completely administered. He looked pale. We had him sit on the ground and he ended up drinking water and resting for well over 30 minutes so we could observe him. At no point did he have trouble breathing or swallowing. We had him stand up for several minutes to make sure not dizzy before he left. He refused a ride home, ambulance and said did not need to get ride home. Said he felt completely back to normal before leaving.
metallic taste in my mouth; tongue feels like it's being coated with something; This is a spontaneous report from a contactable consumer reported for himself. This 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0140), via an unspecified route of administration at single dose on 22Dec2020 for Covid-19 immunisation.  Medical history included cholesterol. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient stated, "I get the vaccine about an hour ago and I didn't see anything stating with the side effects but I have got the metallic taste in my mouth and now my tongue feels like it's being coated with something" on 22Dec2020 with outcome of unknown.  No treatment was performed.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-JUN-2007, the patient was vaccinated with improperly stored VARIVAX dose 1, (dose unknown), from lot # 656078/0169U with expiry date of 17-JAN-2009. No adverse effects reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one the several reports received from the same reporter. Additional information has been requested.
Patient developed swelling and inflamation on 08/03/2015 and it continued to worsen. Area became painful in shoulder and Axillary area.
Breakthrough COVID Hospital. First vaccine 1/6/21, second dose 1/28/21. Patient did not have a booster. Patient is a 79 yo F who lives in nursing home and tested positive for COVID on 1/21/22. Patient started to complain of SOB and palpitations. ED workup included EKG showing controlled afib and CXR that showed partial opacification of the left lung. Patient was found to be in respiratory distress and was started on noninvasive ventilation (BIPAP). Patient admitted to ICU.
This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult male patient who received Herpes zoster (shingrix) for prophylaxis. On 29th December 2021, the patient received the 2nd dose of shingrix (intramuscular). On 30th December 2021, 1 days after receiving shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved. It was unknown if the reporter considered the heart rate increased to be related to shingrix. Additional details were reported as follows: The reporter was the patient. Age at vaccination was not reported. The patient received a dose of shingrix in left arm stated he checked his heart rate every morning and he usually had a heart rate in the 50's. This morning (on the day of reporting) when he checked his heart rate had been running in the high 80's for hours now. The patient was referred to health care professional and was offered medical information number. The patient consented to follow up.
I received my Covid- 19 vaccine on 04/04/2022. On 07/22/2022 I was diagnosed with covid. I was fatigued for three days in a row. I was   prescribed Paxlovid. On the 5th day I tested negative for Covid-19.
Information has been received from a Certified Medical Assistant referring to multiple unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were administered RECOMBIVAX HB (L016427, Expiration Date 13-APR-2017; dose, frequency and route unspecified). The Hepatitis B Vaccine (RECOMBIVAX HB) had been exposed to temperature of 1 degree centigrade, coldest temperature. The total cumulative time was unspecified. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Pt sat for vaccine, admin into L deltoid, bandaid and ice pack put on arm, pt walked out to car and stumbled upon minivan then rollder and fell and dad and I caught him, he complained that the arm was ok but his legs felt funny and his ears felt funny(reported to parent ringing in the ears for few minutes). Pulse ox gotten and was 97% pulse:67(earlier @beginning of visit pulse was 104), bp 110/70 pt felt funny sat for few minutes drank some water then helped to front seat of van, felt better and temp taken was 98.8, pt stated felt ok so family left, will plan to check on pt later
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       How long does someone have flulike symptoms after 2 injection?  how long do these symptoms last? Concomitant medication use was unknown       Reporter did not allow further contact
severe pain and swelling in my right knee; severe pain and swelling in my right knee; The fluid was inflammatory; I have mild arthritis in that knee at baseline; TKR in my other knee; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCIUM taken for supplementation therapy. Vaccination history included: BNT162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 11Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EJ1685, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "I have mild arthritis in that knee at baseline"; KNEE ARTHROPLASTY (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "TKR in my other knee"; INFLAMMATION (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "The fluid was inflammatory"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 02Oct2021, outcome "recovered" (Oct2021) and all described as "severe pain and swelling in my right knee". The events "severe pain and swelling in my right knee", "the fluid was inflammatory", "i have mild arthritis in that knee at baseline" and "tkr in my other knee" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint swelling, inflammation, arthritis, knee arthroplasty.  Additional information: Adverse event: 3 days after vaccine I developed severe pain and swelling in my right knee. Pain was acute onset and required fluid being removed from my knee. The fluid was inflammatory. I have mild arthritis in that knee at baseline. TKR in my other knee. Within a week to 10 days all symptoms were resolved. Ae treatment: Fluid drained from knee. Anti inflammatory prescr.  No follow-up attempts are needed. No further information is expected.
Vaccine was administered very high on my shoulder and caused a lot of pain at the time.  The pain became increasingly worse.  I am now unable to use my left arm with full range of motion without extreme pain in my shoulder and upper arm.
Myocarditis; pericarditis; fever; chills; injection site pain; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:00 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Kidney failure, heart bypass, and diabetes. Patient has no known allergies. The patient's concomitant medications were not reported. On 01Apr2021 08:00, the patient experienced Myocarditis,  pericarditis, fever, chills, injection site pain, tiredness and diarrhea. The patient was hospitalized due to the events for 10 days. Reported treatment for the event (not specified) included "heart stint" (as reported). Outcome of events was reported as recovered with sequelae (Recovered with lasting effects). Event was considered as serious (events caused hospitalization).
Right leg swollen on upper part. Provider will send Rx for ibuprofen and BENADRYL. Patient advised to put a warm wash cloth on area.
Patient felt dizzy and threw up once. I put a cold, wet paper towel on the back of her neck as she had her head down. I also gave her some cold water. Later, she called me to see which vaccination it was that caused the reaction and I told her since she received them both, I wasn't sure. I asked her if she had eaten today and she said she had not at the time of the shots.
"Covid Arm":  Day 10 after 1st dose - Huge triangle shaped rash on injection site ca 4w" x 6h", warm to touch, itchy; no hardness no welts.  Lasted ca 4-5 days.  Slight fever 99.0 fahrenheit (my usual average 97.9-98.0), very slight headache both lasting ca 1.0-1.5 hours when rash appeared after showering.   Since then have received 2nd dose (Moderna #006M20A) same arm as 1st dose;  day 7 and no side affects. I have also reported this on V-Safe App.  (Have picture to share if needed.)