chrisvoncsefalvay/vaers-outcomes huggingface dataset:
S/p 1st covid vaccine 12/22/20. Broke out with hives about 7-8 days later. Hives were all over. Lasted a few days and resolved with benadryl. Got second vaccination dose on 1/12/21 and she developed hives that evening.   Joints started becoming stiff immediately after the second dose. More joints became involved and alternating joint swelling. She has had swelling to the right knee, right big toe, fingers.   She has posterior cervical lymphadenopathy that are improving    She completed 3 steroid tapers with initial improvement but return of symptoms after complete
19 Feb: Received vaccinate roughly 1330hrs. [1400hrs through 2100hrs] lightheaded, slight headache. [1500hrs onward] tightness in throat. 20 Feb: [All day] tightness in throat; fatigue; glands swollen in jaw/neck; joint pain in shoulders and ankles. 21 Feb: [All day] tightness in throat; fatigue; glands swollen in jaw/neck; joint pain in shoulders, lower spine, and ankles. 22 Feb: [as of 1100hrs] tightness in throat; fatigue; glandes swollen in jaw/neck; joint pain in shoulders and ankles.  Takes benadryl to alleviate sysmptoms, declines advise for further care.
On or about November 7, 2022, I began noticing significant increase thigh muscle and glut muscle pain. The doctors discovered some odd things such as a myopathy.  I have seen a neurologist and a physical therapist, and they have both found muscle problems, significant bilateral weakness. I have another appointment in January 2023 with the neurologist, the rheumatologist in December 2022, and an infectious disease doctor in December 2022.
BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and headache. This report was non-serious.
Contracted Covid in the 3rd week of August 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Contracted Covid in the 3rd week of August 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Contracted Covid in the 3rd week of August 2022). At the time of the report, COVID-19 (Contracted Covid in the 3rd week of August 2022) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-659562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659562:Wife Case
At 10 minutes after shot, a "moderate flushing feeling started in legs and moved upwards to chest. Muscle tremors occurred in torso, and arm shaking in lower limbs- elbow to hand. Heart palpitations increased. Blood pressure was 158?/48 the first measure,  Was lightheaded. After baout an hour, Blood Pressure was 140's/50's.  AFter resting in lounge chair for 2 hours, patient was stable enough to walk across room , and could find a ride home. BP later that day was 125/60.  Unfortunately, Blood pressure has been erratic at home even after resting one week.  And was 140 8 days later, but 128/60 today. What will happen with second shot?
Very sore arm; Knocked her off her feet; Vomiting; Diarrhea; Couldn't keep anything down; Flu like symptoms; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter is the friend of the patient.  The patient received the 2nd dose and the 2nd dose knocked her off her feet.  The patient had flu like symptoms for 2 to 3 days.  The patient also experienced vomiting and diarrhea and could not keep anything down. The patient also had a very, very sore arm.  The reporter did not consent to follow-up. This case has been linked with US2021008399 and US2021AMR008922, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008399:same reporter US-GLAXOSMITHKLINE-US2021AMR008922:same reporter
Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am
Aura/Seizure 44 hours following vaccine. Lasted 5 minutes. couldn't think clearly or remember address, workplace, etc. . A 2nd Aura/Seizure episode 72 hours following vaccine. One full week of brain fog and inability to work. Swelling in left rotator cuff area. Numb arm and pain in left hand. Unable to use left arm and hand fully from 3 days after vaccine to 7 days after vaccine. Tired, dizzy, headaches, nausea for a full week.
Immediate discomfort at injection site. The following day Pt developed a low fever of 99.1 and began experiencing headaches. Pt has a hematoma from 1 inch below her left shoulder continuing halfway to her elbow. Pt states the day after her left arm was bruised and swollen.
This spontaneous report was received from a nurse practitioner (also reporter as nurse prescriber), concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L012479 and expiration date on 10-APR-2017 (strength, dose, route of administration or anatomical location were not provided); administered as prophylaxis. The patient did not experience any effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Lip with dermal filler swelled after about 48 hours- started on the side of the shot and then went to both sides. Lasted about 10  hours
1hr p/family brought child to MD office child's lt arm was swollen & red;the lt side of neck had a large indurated hive;hives on face & swollen eyes;ER MD administered DPH;
Pt arrived due to shortness of breath. Was exposed to wife who has COVID. He also has cough and fevers. Pt COVID-19 positive, and admitted with COVID pneumonia and paroxysmal atrial fibrillation.
COVID+ 11/25/2022  Vaccination Status - moderna x 4 + Pfizer bivalent x1 BRIEF OVERVIEW: Admission Date: 11/25/2022 Discharge Date: 11/29/2022   Active Hospital Problems   Diagnosis Date Noted POA ? Altered mental status, unspecified altered mental status type 11/26/2022 Unknown ? Late onset Alzheimer's disease without behavioral disturbance 12/30/2020 Yes ? Class 1 obesity in adult 12/07/2020 Unknown ? Type 2 diabetes mellitus with diabetic nephropathy 11/13/2017 Yes ? Hypertension, essential    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Altered mental status, unspecified altered mental status type COVID COVID-19   HOSPITAL COURSE: The patient is a 92 y.o. female who presented with a history of Alzheimer's, diabetes, obesity.  Patient sent in today to the emergency department because staff at other facility stated patient had increased confusion. Patient has had no complaints.  Patient was on 2 L nasal cannula but able to be weaned to room air but oxygen saturations kept dropping down into the 80s at that time.  Viral PCR did detect COVID-19 PCR. She had a positive test in August. Urinalysis was negative for urinary tract infection. EKG showed normal sinus rhythm.  CT head showed no acute intracranial process.  Mild chronic microvascular sugar white matter ischemic change.  Moderate generalized parenchymal atrophy. Blood cultures were drawn and first set of cultures were positive. She was started on IV vancomycin. According to Antimicrobial stewardship, these were most likely contaminants and antibiotics recommended to be Dc'd. She remained afebrile, labs improved. Mentation is at baseline per family. 2nd set of blood cultures are negative. Vitals are stable, with blood pressures soft, will recommend that lisinopril continued to be held until follow up. She has been discharged in a stable medical condition.
Hepatitis B vaccine received at 1030 AM 9/9/14. 9/9/14 evening at 930 pm noticed welts on back, nasal congestion, sore throat, ears congested.
COVID-19; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: Ep6955), in left arm, on 04Apr2021 as dose 2, single (Lot number: FH8030), in left arm, on 05Dec2021 as dose 3 (booster), single (Lot number: RA5285), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2023, outcome "not recovered", described as "COVID-19"; COVID-19 (medically significant) with onset Jul2023, outcome "not recovered", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (17Jul2023) Positive, notes: Rebound symptoms and positive test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received treatment with paxlovid from 10Jul2023 to 14Jul2023.
did not come back for second dose due to the COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15 October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's comment:  The pharmacist reported that the patient received first dose of Shingrix, but never received the second dose.  The pharmacist believed the patient did not come back for second dose due to the Covid-19 pandemic.  The pharmacist did not have the lot number and expiration date of the first dose.  At the time of reporting, the second dose had not been administered. The reporter did not consent to follow up.
NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.
had symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (had symptoms) in a female patient of an unknown age 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) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (had symptoms). At the time of the report, ILLNESS (had symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/20/2021 and 2/10/2021. Presented to Emergency Department for fatigue and weakness. Family states tested positive for COVID on 1/10/2021. Admitted for renal dysfunction, hypoxic respiratory failure due to COVID-19, sepsis, and cirrhosis. Received supplemental oxygen, steroids, antibiotics and albumin. Sudden worsening of oxygenation status the morning after admission. Supplemental O2 was increased but respiratory status worsened. Expired 1/14/2021.
Patient contacted us on 11-17-16 to inform us she is still having soreness/painful arm after receiving flu vaccine.
on 12/24/2020 I started feeling a little tired on 12/25/2020 I was feeling exhausted i had a cough and breathing problems, also had headaches & fatigue. I'm taking antibiotics for pneumonia   Visited urgent care twice
6X7cm red nard area at injection site of vaccine. Not warm, tender, or fluctuant.
The tissue (or lymph nodes) in the armpit of my left arm started to swell around 6:30pm, which I thought was an extension of a sore arm from the injection site. Then, this swelled into my breast tissue and my left breast was very sore to the touch. This pain lasted for a week post injection under the arm (armpit) and breast tissue
dizzy, headache, blurred vision, vomited after vaccination. (at 03:52 pm) outcome: recovered after drinking water and eating crackers and discharged to home.
Employee received vaccine. Within minutes she had red blotches and a rash on neck and down trunk area and coughing/shortness of breath. Employee was administered liquid benedryl for the minor allergic reaction.
Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse for several hours - up to 118 bpm - normal is 60-70
ONE DAY AFTER VAX, PT EXP SORE THROAT(RESOLVED).NEXT DAY, PT EXP LOW GRADE FEVER, FATIGUE, AND ARTHRALGIA. PHYS DETERMINED EVENTS WERE REACTION TO VACCINATION.1-25-90 RHINITIS. 1-26 CHILLS,JOINT PAIN,EAR PAIN,DIZZY,TENDER SINUSES.
I26.99 ACUTE PULMONARY EMBOLISM 12/28/2022 AV BLOCK, COMPLETE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/28/2022 AV BLOCK, COMPLETE I26.99 ACUTE PULMONARY EMBOLISM 12/28/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/28/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION
Narrative: COVID infections following completion of COVID vaccine series 02/19/21 COVID vaccine dose #1 03/12/21 COVID vaccine dose #2. 07/20/21 Pt reports to PCP c/o dry cough x1 week, fatigue, muscle pain, runny nose; denis chest pain, SOB, ear pain; rx given for levofloxacin, vitamin D, zinc; COVID POSITIVE 07/21/21 Pt reports feeling better; denies ever fever or chills 07/23/21  Pt reports mild productive cough with white/green sputum in the morning 07/24/21 Pt is improving and reports dry cough
ventricular tachycardia; sinus arrythmia; premature ventricular contractions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (ventricular tachycardia) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2008, Benign prostatic hyperplasia and Erectile dysfunction. Concomitant products included FINASTERIDE for Benign prostatic hyperplasia, ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for Cardiac disorder NOS, TADALAFIL (CIALIS) for Erectile dysfunction, LISINOPRIL for Hypertension, FISH OIL and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VENTRICULAR TACHYCARDIA (ventricular tachycardia) (seriousness criterion medically significant), SINUS ARRHYTHMIA (sinus arrythmia) and VENTRICULAR EXTRASYSTOLES (premature ventricular contractions). The patient was treated with METOPROLOL SUCCINATE (TOPROL XL) ongoing since an unknown date for Cardiac disorder, at a dose of 12.5 milligram/ 1X. At the time of the report, VENTRICULAR TACHYCARDIA (ventricular tachycardia), SINUS ARRHYTHMIA (sinus arrythmia) and VENTRICULAR EXTRASYSTOLES (premature ventricular contractions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. GS   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Patient demographics were added. Concomitant medication were added. Second dose of moderna drug was added. Current condition, hypertension and sinus were added.  Outcome of the event was changed. On 07-Jul-2021: Event terms were updated to the final diagnoses and treatment medication was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. GS
Rash between left knee and groin, front, outer and inner side of thigh, started out mild then became dark and inflamed around 2-3 days later; painful, some itching.  By 5/26 it seemed to be drying out, but still looked dark and angry.  June 4-June 14 it was definitely improving and fading.  There are still marks on my thigh.  Gnarly.  ** I am not prepared to take the second dose of Pfizer, and my doctor said to go with Johnson& Johnson.  But to do so I would have to falsify the forms, which I will not do.
No adverse effects were reported; the patient was administered a dose of an unknown Measles vaccine on 12-JUN-2015, then administered a dose of MMR II on 30-NOV-2015; This spontaneous report was received from a medical assistant and a clinical coordinator referring to a 16 months old female patient. Information about pertinent medical history, drug reactions/allergies. The patient's concomitant therapies included the fifth dose of (the number of previous doses was reported as 4) diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (QUADRACEL) (manufacture Sanofi, lot# was reported as C5532AA, in the left thigh) and tuberculin purified protein derivative (TUBERSOL) (lot# was reported as C5482AA, in the left forearm, manufacture was not reported, the number of previous doses was unknown).  On 12-JUN-2015, the patient was vaccinated with a dose of unknown measles vaccine, (manufacture unknown, dose detail, route, lot # and expiration date were not reported) for unknown indication.   On 30-NOV-2015, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 11-APR-2019, the patient was vaccinated with the first (the number of previous doses was reported as 0) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the right thigh, therapy type was rHA (recombinant Human albumin), lot# R030794 with expiration date 22-APR-2020 (dose detail was not reported) for prophylaxis. On the same date, the patient also vaccinated with the sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported), the fifth dose of (the number of previous doses was reported as 4) hepatitis b virus vaccine (unspecified) (manufacture GlaxoSmithKline, lot# was reported as 97LJ2, in the right thigh, dose detail, route, and expiration date were not reported) for an unknown indication. The clinical coordinator also reported that the patient was a new patient, vaccines were preloaded at the time of visit, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was order and given. At the time of the visit, later after vaccine record was reviewed by another nurse, realized measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not needed, both parents was notified by the doctor. The patient did not require any prescription drug treatment for the experience. There was not have temperature excursion occurred after read from the digital data logger either. No adverse effects were reported.
Patient said the arm was red and hot under the injection site. Patient did not seek medical attention. She came to pharmacy on 9-19 to report the reaction. Her arm is getting better per patient.