chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was diagnosed with dementia after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (was diagnosed with dementia after receiving the Moderna COVID-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Memory impairment (Patient had started to have Memory problems approximately 2 years ago).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (was diagnosed with dementia after receiving the Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, DEMENTIA (was diagnosed with dementia after receiving the Moderna COVID-19 vaccine) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient was diagnosed with dementia after receiving the Moderna COVID-19 vaccine, the exact date of diagnosis was not provided. Patient had experienced deteriorating dementia, there was no hospitalization required due to the dementia. Patient visited to health care provider as outpatient.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a 78-year-old female patient with relevant medical condition of Memory impairment, who experienced the unexpected serious (medically significant) event of Dementia, described as deteriorating dementia, which was diagnosed after receiving a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Patient have no previous hospitalization due to dementia and had medical consultation with her health care provider as an outpatient. It was reported that the patient had deteriorating dementia and was not resolved. The medical condition of Memory impairment could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-617739.; Sender's Comments: This is a spontaneous case concerning a 78-year-old female patient with relevant medical condition of Memory impairment, who experienced the unexpected serious (medically significant) event of Dementia, described as deteriorating dementia, which was diagnosed after receiving a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Patient have no previous hospitalization due to dementia and had medical consultation with her health care provider as an outpatient. It was reported that the patient had deteriorating dementia and was not resolved. The medical condition of Memory impairment could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt began to have chest heaviness almost immediately following COVOD-19 Moderna Vaccine.  Minimal SOB.  Chest pressure rated at 2-3/10, BP 164/90.  Pt transported via WC by RN to ER
4hr p/vax pt became pale & flaccid, lethargic, required stimulation to remain awake;was eval in ER given no med or other tx;3hr p/incident started to become pink again & had improved muscle tone but slept more than usual that day;
she woke up at 3AM that night feeling sick; felt flu-like symptoms that lasted until 5pm; really bad body aches but no high fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she woke up at 3AM that night feeling sick), INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) and MYALGIA (really bad body aches but no high fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced ILLNESS (she woke up at 3AM that night feeling sick), INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) and MYALGIA (really bad body aches but no high fever). On 20-Feb-2021, INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) had resolved. At the time of the report, ILLNESS (she woke up at 3AM that night feeling sick) and MYALGIA (really bad body aches but no high fever) outcome was unknown.            No concomitant medications were reported.   Treatment information was not provided. After receiving second dose on 19-Feb-2021, patient woke up at 3 am at that night feeling sick, felt flu like symptoms which lasted until 5 pm and she also had really bad body aches but no high fever.   This case was linked to MOD-2021-363182 (Patient Link).
weakness, UTI Narrative:  Patient with altered mental status, generalized weakness, fever of 102 presented via EMS to local ER on 2/18/21, one day after receiving Moderna COVID vaccine, evaluated and treated for UTI with discharge home same day with resolution of symptoms prior to discharge per family. (ER records have not been rec'd yet to review). Events occurred after business hours, reported and followed up next business day. This PCP is entering report, as report requested a responsible physician, Medical Director for this PCP is listed in the form.
MOSTLY STOMACH DISCOMFORT, SOME DIARRHEA, GENERALLY A FEELING OF DISCOMFORT
Headache, fatigue started same day. Arm soreness that evening, lasted for 2-3 days.
pt recvd vax & devel fever; was crying & irritable; cont to run t even w/ apap; to MD;
Redness/erythema; Flushing; Feeling hot; Increased heart rate; severe bone pain; Chills; headache; malar rash on face; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/erythema), FLUSHING (Flushing), FEELING HOT (Feeling hot), HEART RATE INCREASED (Increased heart rate) and BONE PAIN (severe bone pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine (welts down arm from injection site to wrist (almost in a distribution line) following vein/or nerve gone by day 3) since 2020, Dysautonomia (worsened, sores in nose, vertigo, increased pain in joints and bones, increased dryness, and dizziness) since 2020 and Sjogren's syndrome (worsened, sores in nose, vertigo, increased pain in joints and bones, increased dryness, and dizziness) in 2020. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), NALTREXONE HYDROCHLORIDE (NALTREXON), TOPIRAMATE, PANTOPRAZOLE and KETOTIFEN from an unknown date to 09-Apr-2021 for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced ERYTHEMA (Redness/erythema), FLUSHING (Flushing), FEELING HOT (Feeling hot), HEART RATE INCREASED (Increased heart rate), BONE PAIN (severe bone pain), CHILLS (Chills), HEADACHE (headache), RASH (malar rash on face), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 16-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 22-Aug-2021, ERYTHEMA (Redness/erythema), FLUSHING (Flushing), FEELING HOT (Feeling hot), HEART RATE INCREASED (Increased heart rate), BONE PAIN (severe bone pain), CHILLS (Chills), HEADACHE (headache), RASH (malar rash on face), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.            Patient suffered from Sjogrens flare and vertigo. Date recovered: 22-AUG-2021
I have now had my 2nd vaccination (3/1/21) and had the same reaction both times.  I experienced severe muscle and joint pain starting 12 hours after each injection; this lasted about 36 hours.  I rested and took Advil and Tylenol.  I think this reaction might have been because I received Bamlanivimad 11/24/20 as a treatment for Covid.  Just a thought - I did not contact my doctor and after 36 hours I am fine - I would do it all over again in a hearbeat!! Just thought I would add my comments to your database. Thank you.
In immunization clinic on 6/6/05. Back in HD on 6/9/05; right arm visibly reddened, swollen warm to touch, especially right wrist. Also had reddened area to other arm (left), face which was before immunization. PHN questioned client's mother regarding why her son was scratching extremities and his face, there were reddened areas noted, she related he has sensitive skin, just like I do, he's been that way since birth. LPN had to assist me in giving these injections, as the mother was unable to restrain her son to allow safe vaccine administration. On 6/9, when se returned to the HD with her son, she is advised to follow suggested instructions, to use cool compresses to area at least 20 minutes 2-3 times daily and to use OTC aids such as Benadryl if she choose to or take client to see his physician if this problem persisted. She took client to the pediatrician from the HD, and called back to say the doctor said Y'all should not have given the shots in his arms, don't y'all use the legs. And that he has an infection in his arm and who's gonna pay for this. Explained injection sites to mother and told her I would call the clinic where the doctor practices to obtain a copy of her findings and forward with this report (which I done on 6/9) to provide for payment of patient's doctor bills. Spoke with the doctor's nurse, who related they would forward me the info. I requested (and have received nothing as of this date 6/15) and I called the clinic again on 6/10. I notified the acting director of the health district and made him aware of the situation on 6/9, along with the district administrator. The nurse manager was away on business; was notified when she returned. Called the mother on 6/15 to inquire as to his condition. She relates his is better, still has some redness to his arm and remains on the antibiotic.
Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient reports rash with intermittent itching on upper and lower extremities, torso, and back. Symptoms started three days after vaccination. Patient denies respiratory symptoms, pain, numbness or tingling around the mouth, tongue swelling, or feeling of throat closing. Patient prescribed antihistamines and prednisone. On routine wellness visit one week later symptoms resolved.
Since the very first Moderna shot, in 2-12-21, my arthritis has gone crazy.   While I had arthritis prior to getting vaccinated, I was not having any issues or problems and did not require help from a doctor for it (it did not interfere with my life).  Immediately after the first Moderna vaccine my arthritis noticeably flared. With each additional booster it escalated even more.  So in just 2 years I am having serious issues with the arthritis, so much so that I am barely able to take care of myself (and I do mean barely).   The pain and lack of range of motion in my right hip is so bad I had to see a specialist/ortho surgeon, who reports the arthritis in that hip is severe and I need a hip replacement.  He said there is no other options if I want to get my mobility (and range of motion back).
My injection site started to itch today. When I scratched it, I was surprised to find a hard, large lump all around the injection site.
Headache, Sedation, Fever, L axillary swelling, cold and cough Narrative:   Other Relevant History:
Pt had fever same day at 7:00 pm. Fever was 101. She has fever again at 4:00 a.m. I gave her MOTRIN both time. Next day at 11:00 am. fever was 103.6 and she has seizures. 20 min after she has another seizures. She was diagnosed seizure, febrile in ED
"Administered - 13:50 Adverse event started - 13:55 Patient had flushing/sweating, lightheaded. Patient states did not eat. BP 100/53 (63), HR 60, RR 16, O2 98%. Crackers, water given. Patient stable, released from vaccination site."
I woke up in the middle of the night on 11/25 with a rash on both legs and my right arm. Over the next couple of days, the rash would flare up on different parts of my body (legs, arms, back, neck). I had a med appointment on 11/27 and was prescribed Methylprednisolone, which I began taking on 11/28. The rash flare ups starting going down, but they were still popping up. I went to see my primary care physician, on 12/2 and was prescribed Prednisone, which I began taking that same day. The rash flare ups have improved, however they still persist in small forms as of 12/10.
Body rash and itching reported the day after vaccine administered. Reported on 9/12/14.
Sudden onset dizziness, lightheadedness, fever, body aches, rhinorrhea, nasal congestion, sinus pain and pressure, and sore throat. Symptoms only lasted a day and a half and then resolved on their own. (No harm was done and I recovered with no problems. I am a healthcare provider and thought that it was important to send). I thought that I had the flu because of the sudden onset and the symptoms so I returned to Clinic for a flu test that was negative.
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen.  The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided.  Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy.  Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm.  Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
Pt was given the vaccines that were not meant for her, notified my manager immediately. completing VAERS.
This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored M-M-R II (Lot #, doses, route and sites of administration not reported). This is one of 8 reports from the same source. No additional information provided. Additional information has been requested.
patient received an expired dose of Bexsero on 15Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB38AA, expiry date 22nd July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comment: A pharmacist reported that a patient had received an expired dose of Bexsero on 15th August 2022 which was expired on 22nd July 2022.  The reporter had consented to follow up. The Healthcare Professional (HCP) did not had the patient info like gender, initials, date of birth. Additional supportive information: The patient had received an expired dose of Bexsero, which led to expired vaccine used.
This patient was given what was supposed to be first moderna covid vaccine. However, she actually got her first vaccine at a different facility and  no one was aware. She got the first vaccine in January 21st, so she got her second about 2 weeks too soon. The facility was informed, and they know the patient does not need any more doses.
"Mild" flu-like symptoms including fever (100.4F), chills, muscle/joint aches, tiredness.  Symptoms persisted for approximately 26 hours, & were untreated except for rest.  Left upper arm soreness @ injection site was also present for approx. 3 days.
The patient bad a negative titer to measles, mumps, rubella and varicella.; The patient bad a negative titer to measles, mumps, rubella and varicella; The patient bad a negative titer to measles, mumps, rubella and varicella; The patient bad a negative titer to measles, mumps, rubella and varicella; a 20 year old female receiving one dose PROQUAD 09/02/2020 in error; This spontaneous report has been received from an office manager, referring to a 20 years old female patient (product administered to patient of inappropriate age). The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.  On 02-SEP-2020, the patient was vaccinated with one dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot number and expiration date were unknown) for prophylaxis.         On the same day, the patient had a negative titer to measles, mumps, rubella and varicella (antibody test negative, rubella antibody negative, mumps antibody test negative and measles antibody negative). The outcome of the events (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) was unknown. The causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the events (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) was not provided.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in right arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in right arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Nov2022 at 12:15 as dose 5 (booster), single (Lot number: 0131122A), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2022 at 12:30 as dose 4 (booster), single (Lot number: 049121A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "B 12 Deficiency" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 01Jun2018; VITAMIN B 12 [VITAMIN B12 NOS], start date: Aug2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022 at 12:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 03Jul2023 to 08Jul2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (INTERCHANGE OF VACCINE PRODUCTS,DRUG INEFFECTIVE,COVID-19) and BNT162B2.,Linked Report(s) : US-PFIZER INC-202300247494 Same Patient, different drug/AE;
Headache, joint aches/pains, chills - arms swelling/ redness.
extreme lethargy, sluggish, chills, felt like the flu. resolved after 24 hours
Soreness at injection site began before 2:30 on 9/11/13. Took Ibuprofen within an hour of getting injections. I had a red knot approximately 2 inches in diameter at the injection site. The red knot was evident about 8:30 PM on the 11th. My arm was really sore and very uncomfortable to move. I took some more Ibuprofen. Pain in left arm persisted thru 9/15/13. On 9/12/13 around 8 PM redness spread from the injection site all over my upper arm and shoulder. I contacted my doctor and was instructed to take BENADRYL or CLARITIN. I took a CLARITIN. The redness started getting better Friday (9/13/13) morning. Redness looked like hives all over my arm. The redness full went away by 9/15/13. The knot on my arm was evident until 9/17/13.
Red, warm area L thigh, 4 1/2" X 5", tender and itchy.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified day in February 2015 and on an unspecified day in April 2015, the patient was vaccinated with the first and the second dose of VARIVAX (lot number, expiration date, dose and frequency were not reported) subcutaneously, respectively. On an unspecified day in May 2016, the patient was inadvertently vaccinated with a third dose of VARIVAX (lot number, expiration date, dose and frequency were not reported) subcutaneously. Three days later, on an unknown day in 2016, the patient developed shingles. None laboratory tests were performed. At the time of the report, the patient did not recover from the shingles. The relatedness between shingles and VARIVAX was not reported. The reporter considered shingles as a significant disability as the patient stated that she could not return to work until the shingles had resolved. Additional information has been requested.
Morning after second dose, experienced severe pain running up the left side of neck, top of head and right side of neck - severe ear aches, both ears - Still happening Following Monday (today) my left arm is swollen, red and radiating heat