chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN gave 2 Pfizer 0.3 ml booster doses at time of administration.  No adverse s/s observed or communicated at time of visit.  Adult daughter caregiver present at time of administration.  RN identified dosing  incident to caregiver and provided s/s to monitor and when to seek medical advice or attention.
Approximately 3 weeks post vaccination, patient experienced intense pain going across the shoulders and up the neck. Describes as "bone pain". Had difficulty raising arms, this was painful. Lasted approximately 3 weeks. Pain woke her up in the middle of the night.  Patient reports seeking medical attention from an orthopedist who performed x-rays but they were not remarkable for any disease/injury. Thought it was potentially rotator cuff related but it was on both sides and the x-rays did not show this.
redness & swelling began over upper lt arm PM of 4NOV96;redness & swelling cont to enlarge over area until it was 8" x 5" in size warm to touch;DPH given w/o dec in signs;6NOV96 swelling began to resolve;
b/l feet paresthesias up to mid calf starting within 24 hours of vaccine without history of similar sx. no previous reaction to vaccine. sx are constant and have yet to resolve.
Woke up day after injection with chills and fever of 99.7.  Experienced body achiness and general  malaise with fever increasing 100.7 by afternoon.  Took two Tylenol tablets successfully lower fever.  By 9:00 pm that evening felt much better, but "wrung-out" after this  reaction.   Following day, feeling much better but some linering malaise. Looks like I am going to pull through OK.??
Fever; Constant watery eyes; Eyes hurt; Watery eyes affects vision; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt), VISUAL IMPAIRMENT (Watery eyes affects vision) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 03AK26A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt) and VISUAL IMPAIRMENT (Watery eyes affects vision). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt), VISUAL IMPAIRMENT (Watery eyes affects vision) and PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medication includes Eye Steroid (Alrex), Eye Antihistamine, Oral Antihistamine (Zyrtec).   This case was linked to MOD-2021-071120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: follow up was received on 12-APR-2021 , event was updated
10/31/21 1pm fatigue  10/31/21 9pm fatigue/ body chills/ joint & bone pain in fingers, toes, wrists, ankles, knees, shoulders, back, entire. Body until around 4am  11/2/21 8am mouth feels sore  11/2/21 6pm 3 mouth ulcers on inner cheeks and 1 ulcer on lips.
received the first shot of moderna COVID-19 vaccine and had side effects; 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 ADVERSE DRUG REACTION (received the first shot of moderna COVID-19 vaccine and had side effects) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (received the first shot of moderna COVID-19 vaccine and had side effects). At the time of the report, ADVERSE DRUG REACTION (received the first shot of moderna COVID-19 vaccine and had side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was provided
Patient accidentally received DAPTACEL instead of ADACEL in the office; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from physician and other health care professional via Medical information (under reference number - 00750742).  This case involves a 12-year-old male patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered).  The patient's past vaccination(s) included DTAP VACCINE with Patient has already received 4 DTAP vaccinations.  The patient's past medical treatments, concomitant therapy and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  On 21-Jul-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number U6628AA and expiry date 04-Apr-2022) via intramuscular route in the deltoid NOS for prophylactic vaccination (Wrong product administered).  There were no laboratory data/results available.  It was case of an actual medication error due to Wrong vaccine administered (latency was on same day)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a nurse refers to a unspecified patients of unknown age and unknown gender. The patients medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ. Concomitant medications were not reported. The unspecified patients administered the first dose of ROTATEQ after the patients were 134 weeks and 6 days old. No adverse effects were reported. The outcome of been administered first dose of ROTATEQ after the patients were 14 weeks and 6 days old was unknown. Additional information has been requested.
Approximately 1 hour after receiving the shot I started having intermittent chest pain and heart palpitations.  The following week I two occasions of consistent chest pain that lasted 5-10 mins. I have had heart palpitations every day since receiving the vaccine.
Pt recv vax on 11/11/98; 30 min later pt exp bilateral swelling of throat glands, tight chest, hot vax site
pt recvd 1 dose of Engerix-B & devel hives & itching 5 days p/inject;
PATIENT DEVELOPED MALAISE 48 HOURS AFTER RECEIVING VACCINE; NEEDED BED REST FOR THE FOLLOWING TWO (2) DAYS. SUFFERED MASSIVE ISCHEMIC STROKE ON 10/24/2022.
Patient received Pfizer Bivalent 5-11 year vaccine after it had been diluted (sitting at room temp) for 25 hours. It is unknown at this time if patient has had any adverse symptoms.
On 10/24/05 the pt received AFLURIA (CSL U1771AA). Approximately, 3 hours later a colleague noted that the pt's face was red. The pt felt warm and "fatigued". He reported to medical and when he removed his shirt it was noted that he had red raised "blotches" on his chest, neck, arms, waist and groin. The pt recalls that his temp was 102. He denied pruritus, facial/lip swelling, difficulty swallowing, N,V, increase in diarrhea, SOB, cough. The pt recalls that an IV was started and that he was treated with MOTRIN. He thinks that he was given IV antibiotics but is not sure. The pt was released after several hours. He was seen in follow-up the next day with improvements of his fever and rash but not resolution. He does not recall when his temperature returned to normal but it did take about 3 days for the rash to resolve. There is on documentation of this event in the pt's medical record (paper copy or ER). Of note, the EMR indicates that the pt received an H1N1 vaccination on 1/29/12 and an INFLUENZA vaccination on 11/6/12. These vaccinations are not recorded in the pt's medical record (paper copy) and the pt is certain that he did not receive these vaccinations as he was told in 2005 that he should not receive further INFLUENZA vaccinations.
The patient scheduled appt for 1/30/21 with the Clinic and received at that appointment what was thought to be his first dose of COVID vaccine (Pfizer brand).  Three days later, it was determined that the patient had already received a first dose of (Moderna brand) COVID vaccine on 1/23/21, administered by an outside pharmacy that came to patient's Assisted Living complex. The dose that was administered by the pharmacy was not documented in the pharmacy EHR until 1/31/21 when that documentation was automatically transferred into the state vaccine registry. When the Pfizer brand was administered on 1/30/21, the documentation of the Moderna dose of 1/23/21 was not available to query due to having not yet  been documented and was therefore unknown by the vaccination staff at the 1/30/21 vaccination appointment. The patient also did not have any recall of  receiving any previous COVID-19 vaccine doses, when he was asked during the screening questions prior to administering the 1/30/21 Pfizer dose and when asked three days later. Patient denied any moderate or serious adverse effects from either dose of COVID-19 vaccine. The patient's Assisted Living nursing staff were notified that the patient did receive two doses of COVID-19 vaccine - Moderna as first dose and then Pfizer-1 week later as the second dose. Per CDC guidelines, it is recommended that the patient will not be advised to receive any additional COVID-19 doses. The state registry immunization coordinator and the Primary Care Immunization Program Medical Director were notified  and will be following up with the pharmacy to determine what caused the delay in the documentation of the first vaccine dose and will put safety steps in place to prevent this from happening to future patients.
Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, upper body shoulders to wrists aching.  Weakness of upper extremities. 2\16\2021 generalized weakness fatigue,Felt cold, discomfort to skin during shower from  water pressure.   Difficult getting dressed/ stiffness. Tylenol 500mg q6 hrs and rest all day TX. Feeling better by 4 pm
Fever started approx 45 minutes after receiving injection, followed by body aches and HA.  Pt took Tylenol and ibuprofen for fever and has been taking routine antihistamines Zyrtec and Montulkast.  Thought it was just an exuberant immune response but, today (2/8/13), notices urticarial rash at injection site and under right axilla.  Has taken many vaccines before and has not had this rxn. Given Medrol dosepack at visit 2/8/13.
Sudden hearing loss left ear 2 days after receiving Pfizer covid booster; Sudden hearing loss left ear 2 days after receiving Pfizer covid booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 10:15 (Lot number: 3303080) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: OXYBUTYNIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205), administration date: 02Mar2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262), administration date: 09Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 10:15, outcome "unknown", DEAFNESS (medically significant) with onset 18Dec2021 03:00, outcome "not recovered" and all described as "Sudden hearing loss left ear 2 days after receiving Pfizer covid booster". The event "sudden hearing loss left ear 2 days after receiving pfizer covid booster" was evaluated at the physician office visit. Therapeutic measures were taken as a result of deafness including oral steroids.  Follow up information has been requested
Shortness of breath, racing heart, light headedness, clammy hands and feet. Feeling of faintness. (Racing heart only lasted for 15-20 seconds) Treatment was only sitting still, breathing exercises, drinking water.  Roughly an hour later breathing is normal, lightheadedness is gone, hands are still clammy and sweaty.
05052007  Dtap given @ approx. 10:30 a.m..  TC from mom @12:55 p.m. that child has not stopped fussing and crying since they left the health dept.  He has vomited x 3.  He took a short nap, nursed upon awakening, started crying and vomited again.  Child can be heard crying in the background.  Mom says he draws his legs up to his stomach as though his stomach hurts.  Mom has no primary care MD, no crackers, no carobonated beverages, and no Tylenol.  PHN recommended they go to the Emergency Dept.  At ER, they gave IV fluids, antiemetics and then discharged child to home.
Pt recvd vax & w/in 24 hrs exp extreme fatigue for 3-4 days; resolved;
PT REPORTS ITCHING BEHIND EARS WITHIN 15 MINS OF SHOT. THEN DEVELOPED RASH AND ITCHING  IN GROIN FOLDS. RASH AND ITCHING DEVELOPED IN OTHER FLEXOR AREAS INCLUDING BEHIND KNEES, UNDER ARMS, UNDER BREAST, WITHIN ELBOWS.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pancreatitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Patient administered anti viral drug for COVID 19 Treatment with Paxlovid, treatment start date: 11Jun2022, lot number: GC4027. Patient experienced metal mouth, Everything tastes like metal, adverse event start date: 11Jun2022 07:00 am, Not recovered. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Numbness of mouth (tongue, back of throat. onset was 30 minutes after vaccine and lasted 24 hours
27 days after my second vaccine, my blood pressure dropped to 70/40 and I fainted. I called my doctor at 2:45 am. He told me to drink extra water/have salt/ and take 40mg prednisone and see him at 7am. My BP was higher. He took me off both blood pressure medications and took blood. My WBC count was 1.7 which rose to normal 5 days later. I stayed off the BP medication until Sept 17th (after my booster) and continued to consume a high salt diet and monitor my BP several times a day. My blood pressure was normally 100/70 often dropping to 90/60. If it got too low, I added more salt and fluids to my diet.
On 6-25-2022, I woke up with a headache, chest pressure, cough, burning eyes, temp up to 101.4 and a runny nose. I took a home COVID-19 test with positive results. I called a doctor on call for my primary care physician and they ordered PAXLOVID. I began taking the medication that day. I did not take any over the counter medications for symptoms. I am feeling a lot better now. I am reporting a breakthrough case of COVID-19.
Pt recvd vax 11MAR93; pt restless w/high pitched inconsolable screaming for 4-5 hrs @ time, sleeping in between anorexic lasted for 3 days; had red swollen tender lt thigh; t100.8 noc a/shot given but no given in clinc; lt thigh hematoma;
Pt became pale, diaphoretic, dizzy and light headed. Pt moved to recovery area and laid on cot, vitals done Pt after 15 minutes states he fell fine and left the area on his own power.
Information has been received from a physician concerning a 2 yr old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced mild breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The pt's brother (WAES0602USA05058) had a similar experience after vaccination with VARIVAX. Additional information has been requested. Follow up information from the physician indicated that the he did not remember the patient's name. He just knew there was a kid who broke out with a few bumps and might have had a mild case of breakthrough varicella. There were no cultures or blood tests done.
Sudden headache, nausea, BP 160/90  seated, lightheaded, reddened.  2 episodes, lasting about an hour each. BP  returned to normal between episodes. Slight fever. Muscle aches and even foot discomfort  Sore arm. Arm and hand swelling and redness starting the night of the 24th, remaining today, Jan. 25, 2021
event started: 1-21-2021 at approx 6-7pm; left arm tingling and intermittent numbness, then at 1-22-2021 at 2-3am muscles cramps and unable to move toes bilateral feet and a HA and nausea. 1-23-2021 started with confusion, wondered off at a grocery store and was able to think straight while paying at a register. other than that no other episode.
arm was hurting up to  shoulder and neck area.; Area is feverish.; itches real bad; Huge welts; really swollen; bunch of knots at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (bunch of knots at the injection site), PAIN IN EXTREMITY (arm was hurting up to  shoulder and neck area.), VACCINATION SITE WARMTH (Area is feverish.), VACCINATION SITE PRURITUS (itches real bad) and VACCINATION SITE URTICARIA (Huge welts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (bunch of knots at the injection site). On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting up to  shoulder and neck area.), VACCINATION SITE WARMTH (Area is feverish.), VACCINATION SITE PRURITUS (itches real bad), VACCINATION SITE URTICARIA (Huge welts) and VACCINATION SITE SWELLING (really swollen). On 25-Jan-2021, VACCINATION SITE PRURITUS (itches real bad) had resolved. At the time of the report, VACCINATION SITE MASS (bunch of knots at the injection site), PAIN IN EXTREMITY (arm was hurting up to  shoulder and neck area.), VACCINATION SITE WARMTH (Area is feverish.), VACCINATION SITE URTICARIA (Huge welts) and VACCINATION SITE SWELLING (really swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022 No concomitant product use was reported. Patient received full dose. On 04-Jun-2022 the vials were initially stored in the refrigerator. Vial did not undergo any temperature excursions. No treatment information was provided.
8/7/2021 tested for COVID-19 and was positive, was admitted to medical center with lethargy, minimally responsive, no oral intake.  She expired 8/22/2021 with pneumonia due to COVID-19, Acute hypoxemic respiratory failure, systolic heart failure, difficulty in walking, pleural effusion, bilateral, muscle weakness, atrial fibrillation, diabetes mellitus, and dementia
This spontaneous report was received from a physician via company representative and refers to a male patient about 1 year of age. The patient's medical history, concurrent conditions and concurrent medications were unknown by the reporter. On an unknown date, the patient was vaccinated with the first dose of M-M-R II for prophylaxis, subcutaneously, Lot# and expiration date were not provided. On an unknown date, after his vaccination, the patient experienced, 2 seizures, pyrexia and rash secondary to encephalitis. The patient was hospitalized for 2 days on an unknown date, and was treated with antiseizure medication. It was unknown if laboratory diagnostic studies were performed. The reporter stated that the outcome of encephalitis, 2 seizures, pyrexia and rash secondary to encephalitis was fully recovered. It was unknown if the patient will continue with vaccinations with M-M-R II. The relatedness of M-M-R II and the events encephalitis, 2 seizures, pyrexia and rash secondary to encephalitis as unknown. Upon internal review, the events encephalitis and seizures were considered to be medically significant.
hours ago and about 45 minutes after the vaccine developed diffuse body numbness. Denies weakness denies chest pain shortness of breath nausea vomiting diarrhea he states he has about 3 out of 10 numbness he still feels some things but states it doesn't feel normal. It is diffuse all extremities and his face.