chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 81y.o. male with morbid obesity, atrial fibrillation, type 2 diabetes mellitus, CLL, hypertension, sleep apnea on CPAP, GERD, dyslipidemia, and history of myocardial infarction who presents with shortness of breath. He reports his symptoms started approximately 10 days ago and have been getting progressively worse. He is vaccinated against COVID-19, but has not received his booster yet. He denies any known exposures. He's has associated symptoms of cough, fatigue, malaise, and decreased appetite. He denies fever, chest pain, or lower extremity swelling.   Upon arrival to the ED, the patient was lethargic. He was hypoxic requiring application of high-flow nasal cannula. He did test positive for COVID-19. Chest x-ray confirms multifocal pneumonia. Labs remarkable for lactic acid 2.4, potassium 3.4, creatinine 2.4, magnesium 1.6, BNP 63, LDH 313, ferritin 432, CRP 139.6, D-dimer 613. Serial troponin 0.03, 0.05, 0.04. EKG with controlled atrial fibrillation, no ischemic changes. The patient was started on 20 mg dexamethasone IV QD and empiric antibiotics and admitted for further evaluation and management.    Presently, he is at his baseline mentation. He's just returned to bed from using bedside commode. He desaturates with activity on high-flow nasal cannula, then SpO2 recovers > 92%.     ROS:   Constitutional:  Denies fever, chills, malaise, weight loss, diaphoresis. + fatigue, malaise, decreased appetite Eyes:  Denies double vision, blurry vision. HENT:  Denies tinnitus or change in hearing. Respiratory:  Denies wheeze. + shortness of breath, cough Cardiac: Denies chest pain, palpitations, orthopnea, lower extremity edema. GI:  Denies nausea, vomiting, abdominal pain, diarrhea, constipation, melena, hematochezia.  GU:  Denies dysuria, hematuria or flank pain.  Musculoskeletal:  Denies muscle weakness, joint pain, back pain. Integument:  Denies rash or lesions. Neurologic:  Denies paresthesias, focal weakness, headache, dizziness. Endocrine:  Denies polyuria or polydipsia. Psychiatric:  Denies anxiety or depression.
constant smell of smoke in my nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and administered in arm left, administration date 06Apr2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "constant smell of smoke in my nose". The event "constant smell of smoke in my nose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. It was clearly coming from within and not related to the environment. This lasted all the way from the first dose to the second and cleared up months later. Its been around two months that she did not experience the smell until the day after receiving the booster and has not stopped since.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, chills, body aches, nausea, tired, red swollen arm (redness moving) hot to the touch.
p/ pt recv vax 11/95 in 3/98 devel ``25 pox or less w/white centers'' it was rpt that ``red blisters'' were present for 3-4 days before they scabbed over. m.d. dx her w/chickenpox
Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of Rotateq. The patient subsequently developed rotavirus gastroenteritis. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Swollen area around injection spot. Became red, puffy and irritated about 8 days after the injection.  The spot is still a little red and irritated today. No treatment.
This spontaneous report as received from a medical assistant. It was reported that an unknown number of patients might have received GARDASIL (lot# unspecified) that had been improperly stored. The exact number and identities of the patients were not known at the time of the report. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
I am the patient, and also a registered nurse of 37 years.   The day after the injection my arm was super swollen, red hot, and had a knot in the arm.  As  the days wore on, the pain became more intense and I was unable to use my left arm in any capacity.  The shoulder became non functional, and I couldn't lift the arm away from my side , or form a pushing motion in front of me.  Pain was so severe and upper arm, and shoulder was frozen with pain radiating and stiffness up into the shoulder joint. I had to go through PT and OT to try and recover use of the arm.  Here we are almost a year later and the arm stil lis not functioning properly, has what I call damage in the arm. There is still a hard knot in the arm, and I can't make certain movements with the arm. I can't lay on the arm at all in the bed.  It was either impromper technique when administering the vaccine or the vaccine itself, but as an RN I can tell you it is definitely one of the two, the vaccine or the person administering the vaccine damaged my arm, to the point it no longer functions properly and has reduced my quality of life.
1/4" round pimple like rash at injection site occurring on 10/17/07 no pain, no fever, no drainage, no swelling.  Pt. applied antibiotic cr. & took Benadryl 25 mg at  on 10/24.  Saw Dr. on 10/26/07, Dr. reported the rash was prob from the flu vaccine.
About a year since the first dose; Really sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. The reporter also mentioned she was really sick for 4 days after receiving the first dose in the arm. The reporter was asking if it was okay for her to get the second dose of Shingrix if it had been about a year since the first dose, which led to incomplete course of vaccination. Spoke per content and CDC recommendations to receive second dose as soon as possible and there is no need to restart the series.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 23-DEC-2010, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In 2010, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Patient reported experiencing a severely painful, stiff neck two hours after the injection on 11/30/20. She then started experiencing swollen neck lymph nodes as well as a sore throat and fever that started on Tuesday morning (12/1/2020). She had 100.8 fever (at it's highest) that lasted until the evening of 12/3/20.  Patient has been taking OTC Tylenol q6h, which helped with the pain, but not her fever. Patient presented to her Primary care physician's office on Wednesday (12/2/20). She was tested for strep at that time, it was negative. Bloodwork (Including C-reactive protein-5.1, CBC-normal, Sedimentation Rate-7.0) was also done at that time. Patient is to follow up with her PCP on  the afternoon of 12/4/20
Moderna booster given and it should not of since the FDA says the new Bivalent should be given instead.  Pt. tolerated the booster fine.
Patient, age 7, received Pfizer 6 month to 4 year old vaccination instead of age specific 5 to 11. Patient received repeat dose same day per recommendation from CDC.  No adverse reaction
After the shot for rest of day had a dark shadow in my vision in the right eye. Cleared up by the next day.
I?ve received the vaccine on Sunday and have been having nervous twitching ever since. It has now been over 72 hours since I?ve received the vaccine and the nervous twitching up until now is starting to get worse.
This spontaneous report was received from a registered nurse, referring to a 12 month old (also reported as "15 months") female patient. It was reported none medical history, none illness at time of vaccination and none drug reactions or allergies. On 20-JUL-2017, the patient was vaccinated with the third dose of PREVNAR 13 and the third dose of an unspecified Hepatitis B virus vaccine (manufacturer unknown). On 26-SEP-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously in the left thigh, lot number N017399, expiration date 07-JUN-2019 (strength and dose were not reported), for prophylaxis. It was reported that the vaccine had been inadvertently administered intramuscularly (IM); however the registered nurse confirmed that it was subcutaneously rather than IM. Other suspect therapies included an unspecified Hepatitis A virus vaccine (manufacturer unknown) (first dose, in the left thigh, lot number N017094) which was administered on 26-SEP-2017. Concomitant therapies included a PREVNAR 13 (fourth dose, in the right thigh, lot number 535324) administered on the same date and an sterile diluent. On 26-SEP-2017, the patient experienced a red hardened area of about 1.5 inches, at the site of the VARIVAX injection (vaccination site erythema and vaccination site induration). On 27-SEP-2017, the patient went to office. No treatment was provided and lab diagnostics or studies were not performed. The nurse practitioner (also reported as the responsible physician) determined that it was an injection site reaction and told the patient's mom to continue monitoring. The outcome of vaccination site erythema and vaccination site induration was reported as resolved. The causality assessment between VARIVAX and the aforementioned events were not provided.
Chills, Feverish, tired, injection site pain, headache.  Excedrin helped a lot and resting.
Moderna COVID?19 Vaccine EUA,   Approx 18 hours after the shot I experienced intense chills, overall fatigue, fever, burning eyes and joint pain for the next 18 hours.  I took no pain relievers and awoke on the second day with no ill effects.
Patient developed numbness on the right side of her face; The symptoms developed 24 hours after vaccination. She is being treated with prednisone.
Immediately after vaccines given, baby began to cry inconsolably. Her legs became discolored purple and red.
arm was sore; headache; flu-like symptoms; injection site was very red; rash; itchy; very hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (injection site was very red) and RASH (rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, FINASTERIDE, DOXYCYCLINE and ATORVASTATIN for an unknown indication.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (arm was sore), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (injection site was very red), RASH (rash), PRURITUS (itchy) and VACCINATION SITE WARMTH (very hot to touch). At the time of the report, INJECTION SITE PAIN (arm was sore), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (injection site was very red), RASH (rash), PRURITUS (itchy) and VACCINATION SITE WARMTH (very hot to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
1ST  / SHOT / GOLF BALL LIKE SWELLING IN THE RIGHT ARM PIT; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced local swelling and incomplete course of vaccination. On an unknown date, the outcome of the local swelling was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st  shingrix shot June 2018 in upper right arm and experienced golf ball like swelling in the right arm pit.    Till the time of reporting, the patient had not taken the 2nd shingrix shot, which led to incomplete course of vaccination. The reporter consented to follow up.
Left arm swelling; Injection site redness; painful said that it is located an inch below the injection site; A spontaneous report was received from a Consumer concerning a herself, 42 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, Left arm swelling, Injection site redness, and Injection site pain.  The patient's medical history was not provided.  The concomitant medications included fexofenadine hydrochloride, hydroxychloroquine sulfate, and spironolactone.  On 30 Dec 2021, approximately one day prior to the onset of the events, the patient received their unknown of the two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route on left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2021, the patient left arm swelling, Injection site redness, and Injection site pain.  The treatment information included Allegra and Ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of this report, the outcome of the events, left arm swelling, Injection site redness, and Injection site pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient did not suffer any adverse reaction.  Patient was below the age limit of Moderna vaccine.  Patient is 17 years and 8 months old, will be turning 18 in June of 2021
Vaccine given to 11 month old which is age restricted to 2 yr old to adult
HAVE PAIN ON  SHOULDER DOWN TO ARM; CAN NOT MOVE ARM; 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, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced have pain on shoulder down to arm, and can not move arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the have pain on shoulder down to arm and can not move arm was not reported. This report was non-serious.
I started getting violently ill the evening I had the vaccine about 8:00pm. Over the next 16 hours I vomited 10-12 times. Lost count. I could not even hold down water over those 16 hours. Later about 24 hours after it started, I could drink water and Gatorade. Another 8 hours I had some noodle soup. Today, I am still very week and I am easily winded. My arm and neck really hurt but the nausea is over and I am able to eat.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: ET7534) at the age of 79 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Peripheral neuropathy" (unspecified if ongoing); "Syphilis" (unspecified if ongoing); "Giant cell arteritis" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "NPA" (unspecified if ongoing), notes: I have NPA which is normal pressure. Concomitant medication(s) included: Gabapentin; Propanol; Celecoxib; Simvastatin. The following information was reported: BLISTER (non-serious) with onset Mar2021, outcome "not recovered", described as "I got blister on the tips or point of each finger on each hand"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "My finger is numb and sore at my finger tip"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "My finger is numb and sore at my finger tip.". The events "I got blister on the tips or point of each finger on each hand", "my finger is numb and sore at my finger tip" and "my finger is numb and sore at my finger tip", were evaluated at the physician office visit. Therapeutic measures were not taken as a result of blister, pain in extremity, and hypoaesthesia. No follow-up attempts are possible. No further information is expected.
Breakthrough Case; Breakthrough Case; Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion Reported Event: Breakthrough Case Awareness Date : 22Dec2021 This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown and all described as Breakthrough Case. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 17 yr old male who at the age 15 months and 5 yrs was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, a recent titer showed no immunity to measles and rubella. Unspecified medical attention was sought. The pt's outcome was unk. Additional information has been requested.