chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate high fever and tiredness after each Hep B vaccine. 3 mo's after last of 3 Hep B's patient appetite decreased and fatigue increased. He went from top of growth curve to below avg and continued to decline. Central nervous system difficulties rose - sounds, taste, touch all senses hyper. Age 9-10 became anemic, life threatening. hospitalized. No tests could confirm problem. Had "hepatitis like rash, blisters, fever from age 5-10. Shut down immune system with IV prednisone. Home schooled. Still low weight, tries easy L.D.- math, slow reader, processing raised. 60 Day Follow-up Information 26-MAY-2009: Still suffers chronic fatigue (motor, sensory as well as learning), impaired level of processing speed math skills, reading speed, transcri... Still being homeschooled since traditional school setting was too intensive in early years. Irritable bowel syndrome due to extra yeast in intenstine. Platelets still remain high. Immune system still weaker than should be - will get sick if around "normal" amount of children with viruses. Still has raised inflammation ESR level and all reasons for it have been medically ruled out. P.S. We are very thankful to have a place, finally where patient's unique situation (that we know of) can be documented. We do know that his lot of vaccine was revamped in the late '90's. Follow-up: Difficulty recovering from viral infections. Retarted growth. Learning disabilities -> some impairment fatigue. Severe Crohn's disease diagnosed this year - had been previously suspected from age 5 on.
Received 1st dose of covid vaccine on 2/3/21, 2nd dose on 2/24/21, admitted to hospital on 3/1/21 with acute respiratory failure/COPD exacerbation, tested negative for COVID, afebrile, vitals wnl, no signs for bacterial/viral infection.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of several reports received from the same reporter. Additional information  has been requested.
I've taken normal mammograms before, but in October 2021, the doctor found a breast lump that was not there previously. On 11/18/2021, I took some studies and they discovered a breast anomaly. On 12/08/2021, I did a biopsy.
Diarrhea began 3 days later and has been on and off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea began 3 days later and has been on and off) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea began 3 days later and has been on and off). The patient was treated with ELECTROLYTES NOS for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea began 3 days later and has been on and off) had not resolved.            The reporter stated that diarrhea was like pouring out a bucket of water.  Additional treatment information included yogurt and lots of water.   This case was linked to MOD-2021-047783 (Patient Link).
2nd shot on 4/17 adverse symptoms started late on 4/25/21 with itching and a couple of welps on back left side of neck by next afternoon (4/26? intense itching began on upper back between shoulder blades up to neck - on 4/28 began using Benadryl allergy pills and hydrocortison and ice pack on back for sleeping, also tylenol - sort of thought maybe chiggers for some reason - 4/29 itching, welps had spread aroun back of neck to right side all the way to under my chin - began using apple sider vinegar throughout day along with Benadryl and remembered about the herpes vortax being assocciated with vaccine side effects - never had shingles before some some of pains made me think of nerve reactions - will call my dermatologist for appt on 4/30 if I can't be seen will go to primary care dr.
Two days after getting the Moderna covid-19 shot I started to get muscle and joint pain and still have it in my hands and shoulders .  it has been 3 weeks now and I am do to have my second shot this weekend, and I am not sure if I should get it.
Assessment: Patient was seen today for follow-up.   Diagnoses and all orders for this visit:   HSV-1 infection, facial Comments: didn't tolerate valtrex; plan trial of acyclovir   COVID-19, recovered Comments: reviewed his reaction likely is due to his having the vaccine 2 weeks after being dx with covid rather than waiting 3 three months   Adverse reaction to COVID-19 vaccine   Maxillary fracture, left side, sequela  Comments: planning hardware removal   Other orders -     acyclovir (ZOVIRAX) 400 MG tablet; Take 1 tablet by mouth 3 times daily for 5 days.   25 minutes were spent in clinic with this patient/family. Greater than 50% of this visit was spent in counseling services.
Got sick after; 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 ILLNESS (Got sick after) 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 ILLNESS (Got sick after). At the time of the report, ILLNESS (Got sick after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information mentioned.  Patient described the event as knowing many who got sick after getting the vaccine.
diarrhea; feel a little shaky and a little off; feel like post flu; very bad body aches; lots of sputum; nausea; vomiting; terrible headache; chills; really hit me hard; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches) and PRODUCTIVE COUGH (lots of sputum) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches), PRODUCTIVE COUGH (lots of sputum), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (terrible headache), CHILLS (chills) and MUSCULOSKELETAL DISCOMFORT (really hit me hard). At the time of the report, DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches), PRODUCTIVE COUGH (lots of sputum), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (terrible headache), CHILLS (chills) and MUSCULOSKELETAL DISCOMFORT (really hit me hard) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
2 weeks, post vax, pt presented with headache, rash (maculo-papular; started on head and neck and spreading caudally), fever to 101.8 and sweats X 2 days. Exam showed as above, plus occipital LAD, a few petechiae on buccal mucosa.
A non-serious spontaneous report of about ten adult patients only got a half dose of H1N1, Intranasal was received from a physician. Neither relevant medical history nor concomitant medications have been reported for this patient. Nurse did not remove the dose divider clip when she administered the doses due to which patients only received a half dose each. On 23-Oct-2009, ten patients received H1N1 vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Broke out in hives starting on her back then to buttocks and legs. Took Benadryl tabs for next 24 hours.
Quadracel given by mistake instead of the age-appropriate vaccine no adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 months old and unknown gender patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] given by mistake instead of the age-appropriate vaccine no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5ml dose once (1X) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site for immunization given by mistake instead of the age-appropriate vaccine no adverse event (product administered to patient of inappropriate age) (unknown latency). The dose was given about a week ago. It was asked that is there any consequences or potential adverse risk to a 10-month old who received Quadracel instead of the age-appropriate vaccine.  Action taken : not applicable.  Outcome : Unknown.   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.
Fatigue started 03/05/2021..Sinus pressure on 03/08/2021...awoke with rash on right arm, chest, stomach, back on 03/09/2021
While at home, two hours after the injection (2:30pm), I experienced dizziness, body aches and EXTREME RINGING IN MY EARS. Ringing lasted for approximately 1 hour. While ringing was felt in both ears, it was more pronounced in my right ear. Dizziness and body aches continued for the next 12 hours.
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. No medical history was reported. On an unknown date in 2008, the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported) intramuscularly. On 10-JUN-2013, the patient was vaccinated with dose 2 GARDASIL (lot #, expiry not reported) intramuscularly. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On 11-MAR-2016, the patient was inadvertently vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # and expiry date unspecified). The vaccine was exposed to the following conditions: 87 degree F temperature, for a time from of 8 hours. There were no previous excursions. No adverse effects were reported. Additional information has been requested.
low-grade fever after the first dose, 99.3°F; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported via an unspecified route of administration on an unspecified date at a Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced low-grade fever after the first dose, 99.3 degree Fahrenheit. The reporter had scheduled for the second dose of Pfizer's COVID-19 vaccine on 02Apr2021. Around that time, she was also due for Prolia injectable, a biologic which she gets every 6 months. She queried if there an interval to wait and if she can take NSAIDS. The patient underwent lab tests and procedures which included body temperature: 99.3 degree Fahrenheit on an unknown date. The reporter consider event as non-serious. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After injection, initial injection site became swollen to the size of a dime and disappeared after 48 hours. After 9 days, size of injection site quadrupled in size, became firm,  warm to the touch and itched.
right side on throat is real tender; Injection site is hot to touch; mouth sores the whole mouth has a lot of sores; fever blisters; thrush tongue is real white; felt so cold; Horrible chills; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (mouth sores the whole mouth has a lot of sores), ORAL HERPES (fever blisters), ORAL CANDIDIASIS (thrush tongue is real white), FEELING COLD (felt so cold) and OROPHARYNGEAL PAIN (right side on throat is real tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant in 2001.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (felt so cold) and CHILLS (Horrible chills). On 13-Mar-2021, the patient experienced STOMATITIS (mouth sores the whole mouth has a lot of sores), ORAL HERPES (fever blisters) and ORAL CANDIDIASIS (thrush tongue is real white). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (right side on throat is real tender) and VACCINATION SITE WARMTH (Injection site is hot to touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, STOMATITIS (mouth sores the whole mouth has a lot of sores), ORAL HERPES (fever blisters), ORAL CANDIDIASIS (thrush tongue is real white), FEELING COLD (felt so cold), OROPHARYNGEAL PAIN (right side on throat is real tender), VACCINATION SITE WARMTH (Injection site is hot to touch) and CHILLS (Horrible chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-JAN-2014, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-NOV-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Petechial rash + bruising + oral bleeding 4/10. 4/11 ER - transferred to hospital. IVIG + Prednisone for thrombocytopenic purpura.   4/21 Link w/344276. 4/21/09 Received hospital medical records of 4/12-4/14/2009. FINAL DX: immune thrombocytopenia purpura; recent viral infection Records reveal patient experienced rash all over that increased to blotching & bruising.  Seen in ER where plt count 3K & pt transferred to higher level of care.  Sick family member w/flu-like symptoms.  Pt had clear rhinorrhea x 1 wk & was teething.  Heme/Onc consult done.  Tx w/IVIG x 2. steroids.  Improved  & d/c to home on tapering steroids w/PCP f/u.  Follow-up - Continue's blood test so far so good. Visit with hematologist -stable.
mom reports jerking movements onset 9PM 9JUL94 head felt warm; temp later rose to 103 that did return to nl w//APAP; taken to ER strep & CBC done; cont to run temp of 103 that responded to APAP; alert & irritable;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After testing negative for 3 days; Negative, notes: After testing negative for 3 days; Negative, notes: After testing negative for 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not had other medication in 2 weeks. No known allergies. The patient had treated for COVID-19 with anti-viral drug from 12Sep2022 to 16Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
05/01/2022  I was having dental pain on the left side.  I spoke to my dentist, and he said I might be brushing too hard on one side. They had me use a special toothpaste and in several weeks it should go away. But it did not. Then I began having the pain on both sides of my mouth. It was uncomfortable sensitivity, like drinking something cold or warm. This went on for a couple of weeks. I work up one morning and it felt like someone had punched me on the left side of my face. It was very painful.  . I could not get anything to relieve the pain. I tried ice, heat, Alleve and the pain just would not stop. doctor examined me and said he saw nothing that would cause irritation. There were no signs of swelling. He felt around my jaw and did not feel anything.  He thought it might me trigeminal myalgia.  He put me on Prednisone and Gabapentin. After about 48 hours, the pain started to subside. After three more days I did not feel any more pain. My doctor told me to go back to my dentist just to make sure it was not a dental issue.  I went back to my dentist who did a full x-ray, full examination, examined my mouth and jaw and found nothing wrong.  I have been on Gabapentin ever since which seems to be the only thing to help the pain. I missed one dose and within three hours, I was in excruciating pain. I then started experiencing vertigo. I had a tele visit with my doctor, two weeks ago, and he has referred me to a Neurologist. I read online that some people who have had the vaccine have  ended up with trigeminal myalgia.
Left subcutaneous site of Varicella (primary vaccine) has cluster of 10 macules, no vesicles, no vomiting.
Patient had nausea, vomiting, body aches, headaches and fever for hours throughout the night
Began having chest heaviness and shortness of breath that night. It continued all weekend. I stayed out of work Monday the 13th, because it was very uncomfortable and I couldn't take deep breaths. Thursday the 16th, I left work early to go to an urgent care because my chest was starting to hurt in addition to the heaviness and inability to take deep breaths. Because of long wait times at the 3 clinics I tried, I went to Hospital and spent the night there. At that point, I was having trouble breathing, my chest hurt and my left arm hurt and my left palm was tingling.  After they ran all their tests (listed below), they discharged me. Friday, I went to a respiratory clinic where they gave me treatments, a covid test, and 2 prescriptions: Albuterol inhaler and prednisone 10mg 1 tab tid. The covid test came back negative 3 days later. Today it is 09/23/2021, almost 2 weeks since receiving the vaccine, and I still cannot take deep breaths or yawn without it hurting. I am using the inhaler daily, and am on the last dose of the prednisone they ordered last Friday (09/17/2021).
Patient called MD office and reported area of redness around injection site. Talked to doctor's nurse on 5/19 -> f/u. Pt never called back to report any worsen of condition. Contacted pt 3 times to find detail of rash but never call back.
The person who gave me the shot placed the injection too low on my arm. It should have been up near the shoulder, but instead the person gave it to me down toward the middle of my arm. I knew something was wrong immediately because it felt so warm and disruptive. The doctor on the scene said it was nothing. Nine days later I went to Urgent Care with swelling, hot-to-the-touch, itchy and a huge knot. The Urgent Care Dr. gave me a five-day prescription for Prednisone and also gave me a prescription for hydroXYzine pamoate, which is an antihistimine.
Rapidly progressive descending paralysis with bulbar symptoms (ophthalmoplegia, facial weakness) and with hyporeflexia and truncal ataxia progressing to near-complete paralysis and areflexia.  Intubated electively on 3/15/2013 to protect airway.  Still intubated in hospital now.  See attached hospital notes (labs and consults).
About a half hour after receiving the vaccine I started feeling a numbness under my right eye that progressed slowly progressed to around my right eye,  cheek, ear and upper right side of my teeth. I was able to move my muscles (no crooked smile) and close my eyes completely. Today I still have this strange feeling but it's very subtle.  This hasn't worsened at all since yesterday but hasn't gone away either.
small, hard lump under skin p/immun progressively got larger; approx 1 month ago became larger; got head on it & daughter opened it on 2JUL; puss expressed; today raised area approx 10 x 10mm lt arm; lt of smallpox scar;