chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 180 days after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results of human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
mild swelling, blotchy erythema, severe pain in the area of Pneumovax vaccination no reaction on the other arm where influenza vaccine was given
pt recvd Recombivax HB vax 1DEC87, 7JAN88 & 10JUN88 & @ the time of 3rd inject pt was 2 months pregnant; 16JAN89 p/12 hrs of labor pt gave birth to baby w/down's synd; during 3rd trimester pt devel preg induced diabetes mellitus;
Dizziness for couple hours after shot, Soreness at injection site 5 days; Headache 2 days; Nausea 1 day; Muscle and Joint aches 4 days, Tiredness 4 days
approx 2yrs p/vax pt exp breakthrough chickenpox w/22 lesions over body This is in follow-up to report (s) previously submitted on 5/14/1999. Information has been received from a health care professional concerning a 4-year-old female who on 03-JAN-1996 was vaccinated with one dose of VARIVAX SC. On 16-NOV-1998 the patient experienced breakthrough chicken pox with 31 lesions noted on the trunk, arms, legs, and some on the face. Information dated 23-APR-2007 from a registered nurse reported that on 14-JUN-2000 the patient was vaccinated with VARIVAX (Merck). On 21-APR-2007, the child came down with chickenpox. Symptoms included rash and fever. Outcome was not reported. In follow-up, the reporter indicated that there was no record of this patient. In follow-up information, the nurse reported that the office did not have this patient listed as a patient. No further information is available.
Patient complained of arm pain after injection. She said she could not lay on arm that night. Patient contacted staff on 11-16-2017 and said that arm had not gotten better.
Sore upper arm, limited mobility of arm, stiffness, unable to sleep due to pain.
Pt sent letter to pharmacy stating: I am 65 years old.  I was given an Influenza Virus Vaccine October 6, 2021 by a staff member in your pharmacy.  I've had several flu vaccines throughout the years, and other than a bit of tenderness at the injection site, I've never had an issue whatsoever.  This time I did.  The person administering the vaccination gave me the injection, and although the injection itself was painful, I didn't think anything of it.  The employee told me to remain for 15 minutes in case of a reaction of some sort.  I agreed but told her I had some shopping to do that would take at least that long.  Before leaving the store, I did notice my arm was in pain, but recalled other friends have told me their flu shots were painful, and in some cases lasted a week or so.  My arm has remained in pain since that day.  I am an avid workout individual, and every active person.  My left arm is limited in performing everyday functions, such as attaching my seatbelt, carrying my 2 year old granddaughter, putting on clothes, working out, and reaching to some length.  the pain even affects my sleeping.  Since October 6th, I have not had a complete night of sleep.  I did finally perform an internet search and found that my shot could have been given with a larger needle than my small frame can handle.  Another article mentioned a flu vaccine could cause a type of pre-arthritis.  Anyway, I did finally see a doctor today (pt's letter was dated 11-29-21 and received by pharmacy 12/20/21) and she is treating me with a drug for possible inflammation and muscle relaxer to help me sleep.  I know I possibly should have notified you earlier, but I continue to believe the pain would eventually subside, and I'm certainly hoping it does now that I have medication.  I'm notifying you at the request of my doctor.  She believes, if it's possible the pain is directly from the vaccination, then it's vital that I notify you, so that this does not happen again.  I know I will certain be asking more questions about needle size etc before getting another vaccine of any sort.
Hospitalized 1/20/22-1/31/22 for kidney failure, COVID19. Treated with Remdesivir,  dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
Breakthrough case. Started feeling achy and feverish on 7/4/2022, took a Home test on 07/07/2022 and tested positive. I was prescribed Gabapentin after my first vaccine reaction. My Dr. increased my dosage. Still feeling bad but tested negative for COVID-19 now.  Long haul COVID-19 and symptoms have never completely gotten better.
SHOULDER JOINT HURTS BOTH HANDS JOINTS STIFF IN MORNING WORSE
Pt saw her PCP due to red, inflamed area around injection site. MD believes may be infection. Pt is to monitor and return to MD.
Patient's father called on Monday after the vaccine was administered on a Friday. He explained that she broke out in hives from her "eyes to her feet". Patient called her primary treatment team and was advised on how to handle reaction.
Itching post vaccination approx. 30 min, Fever  (100.9) 6am 5/9/21, nausea, HA--mild persistent.
Massive headaches, sinus, wheezing, lethargic, phlegm, sleeping longer than usual, always drinking water, sneezing, sniffling.
Received Pfizer COVID vaccine at 12:38om. At 12:53pm reported feeling heaviness in tongue. Benadryl administered at 12:56pm. reports relief of symptoms at 1:04pm.
Information has been received from a physician concerning a 12 month old female with no medical history or allergies who on 11-MAR-2009 received the first dose of VARIVAX (Merck) (lot# not provided) in the leg. There was no concomitant medication. 10 days after vaccination, on 21-MAR-2009, the patient experienced fever for 24 hours. The patient also developed rash papular, which came out in crops over 3 days with over 200 lesions all over the body. On 26-MAR-2009, the patient recovered from fever and rash papular. The reporter considered the adverse events to be non-serious. Additional information has been requested.
administered Moderna booster (0.25ml) dose for unapproved age (12 years old).  Informed parent.
Mutiple rash outbreak, including injection site. No treatment at this time as patient seems comfortable.
Patient is a type 1 diabetic who experienced an extreme spike in his blood sugar hours post vaccination. He denies having any food or activity that could contribute to the spike. His blood sugar has remained in the 400 to 600 range overnight, despite him increasing his insulin administration. He has had flu shots in the past and never experienced such a spike.
Exactly 10 days after vaccination arm is itchy red and swollen. Same arm that was vaccinated..
Reported that approximately 45 minutes after vaccine administered pt collapsed and quit breathing for about 30 seconds. Pt started breathing with minimum effort and was taken to ER. ER reported that there may have been an unknown egg allergy or a combination of the fact that pt was on menstrual cycle, had not eaten, and had not taken that days dose of sertraline. Pt was released the same day.
Symptoms started as an abnormally high fever after the vaccines. Fever got higher and would not break under 102 degrees. This went on for four days before he went back and was diagnosed with an ear infection and put on antibiotics. Started antibiotics, symptoms got worse and fever got higher. Fever was 105.2 degrees when he had the first febrile seizure, which was followed by two more and then categorized as complex febrile seizures. We was taken to ED via ambulance. There he was admitted. August 26, 2018, he was diagnosed with Kawasaki Disease with a 2.6mm dilation in his right coronary artery. IVIG was given, symptoms reversed. November 19, 2018, his dilation was closed and he has been considered Kawasaki free.
5 minutes post vaccine, patient became dizzy and experienced syncope. Patient was brought to ER. Patient had not eaten any food that day.
Less than one week after injection I began having severe diarrhea, nausea.  My abdominal area began to swell.  Pain in the mid section. Lots of exhaustion bouts.  This has gone on since it began and we are now at July 7, 2021 and am still having diarrhea and dealing with bouts of fatigue.  I have been to gastroenterologist and my regular physician.  Nothing has been found as what is causing it.  I am scheduled for a colonoscopy in August.  I don't know what to do.
Infant was given vaccines. Cried, and then became very pale and limp about 60 seconds later, lethargic. Color improved over 10 minutes. Infant remained very sleepy.  Infant had several more limp/pale events over the next few days after the vaccines.  Had a normal holter monitor exam.  Suspect this may have been a vasovagal/breath-holding spell event.
Nausea; Chills; Headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on left arm on 19Jan2021 14:15 at single dose for covid-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol, lisinopril, estradiol, sertraline and tramadol hydrochloride (TRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, chills, headache, cough, all on 19Jan2021. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
cerebellar CVA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient was very healthy and active. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: CEREBELLAR INFARCTION (medically significant), outcome "unknown", described as "cerebellar CVA". The patient had no risk factors other than being 70, very healthy and active. The patient had a cerebellar CVA 2 weeks after the booster.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
My mother was diagnosed last week with acute systolic congestive heart failure. She has no previous history and no family history of cardiac problems. She had felt short of breath since "at least June" and decided to tell me almost a month ago when I noticed she was short of breath just talking on the phone. Long story short she was referred to cardiology and a cardiac cath was done which determined the cause was not due to coronary vessel disease. The cardiologist believes she had a virus sometime in March-May after hearing her describe her symptoms. While our family truly believes in this vaccination, they can have adverse side effects and we wanted to report it incase she isn't the only one. We are also aware she could have came down with covid and not have known it.
Received vaccine in the morning, was sent home about 4 pm, went to the ER, received Benadyl I believe for slightly puffy facial area.  Called off on 7/22/2021.  Nurse from nursing home spoke to her on 7/23/2021 and she felt fine except a sore arm.
This spontaneous report was received from a pharmacist via a company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 06-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed a large red spot (also reported as redness) a couple inches from the site of the injection (erythema). At the reporting time, the outcome of erythema was unknown. The causality between PNEUMOVAX 23 and the event of erythema was not assessed. Additional information has been requested.
I had a real dizzy spell; I pulled the alarm. The nurse came in checked my blood pressure; it was really high. She called an ambulance to have me transported to the emergency room to rule out that I may be having a heart attack or stroke. Once at the emergency room they ran an EKG, CAT scan, and complete blood panel, all three tests came back negative. They did add a blood pressure medication to my routine medications.
Was in the hospital a few days for "unrelated reasons" to the flu/Coughing, and the coughing will likely last 6 months/Cold; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Was in the hospital a few days for "unrelated reasons" to the flu/Coughing, and the coughing will likely last 6 months/Cold) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Was in the hospital a few days for "unrelated reasons" to the flu/Coughing, and the coughing will likely last 6 months/Cold) (seriousness criterion hospitalization). At the time of the report, INFLUENZA (Was in the hospital a few days for "unrelated reasons" to the flu/Coughing, and the coughing will likely last 6 months/Cold) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received two Moderna primary series doses and two Moderna booster doses.The patient stated his last booster dose was 4 or 5 months ago.  The patient was in the hospital a few days for unrelated reasons to the flu. Patient reported that during his hospital stay, he came down with the flu and reported he then had a cold. Patient stated that he was coughing, and the coughing will likely last 6 months.   Treatment information was not provided.  Company comment: This spontaneous case concerns an adult male patient with Concurrent medical conditions of Immunocompromised who experienced the unexpected serious (hospitalization) event of Influenza which occurred unspecified days after receiving the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication, treatment details were not provided, and the event outcome was unknown.  Patient's Concurrent medical conditions of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-607773 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult male patient with Concurrent medical conditions of Immunocompromised who experienced the unexpected serious (hospitalization) event of Influenza which occurred unspecified days after receiving the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication, treatment details were not provided, and the event outcome was unknown.  Patient's Concurrent medical conditions of Immunocompromised remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
General flu-ish feeling; headache; fatigue; chills; extreme cold (freezing) hands and feet followed by fever; fever; extreme constipation lasted 6 days.; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 28Feb2021 at 15:15 as single dose for COVID-19 immunization. Vaccination facility: Public Health Clinic. Medical history included wrist injury and allergy to Oxycodone, which was taken after wrist surgery. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 07Feb2021at 13:00 as single dose for COVID-19 immunization. Patient did not receive any other vaccine in four weeks and no other medications in two weeks prior vaccination. Patient not diagnosed with COVID-19 prior vaccination. On 01Mar2021 (next day of vaccination), patient experienced general flu-ish feeling, headache, fatigue, chills, extreme cold (freezing) hands and feet followed by fever. Fatigue, slight headache and extreme constipation lasted 6 days. No treatment was received for the events. The patient was not tested for Covid post vaccination. The outcome for all the events was recovered.  No follow-up attempts are possible. No further information is expected.
received improperly stored doses of VARIVAX; No adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 21-OCT-2020 ) (strength, exact dose and route of administration were not reported) for prophylaxis. It was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date not reported). No adverse effects were reported. Administered dose of vaccines experienced the temperature excursion between 15 and 46 Fahrenheit degrees (also reported as between -9 and 8.Celsius degrees; also reported as 17.6 Fahrenheit degrees) for 2 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA013180:
Information has been received from a health professional concerning a 4 year old female with no allergies or medical history who on 25-FEB-2003 was vaccinated IM in the left arm with a first dose of Varivax (lot # 643820/0864M). There was no concomitant medication and no illness at the time of vaccination. On 28-DEC-2006 the patient experienced numerous erythematous lesions about 1 cm in size scattered over the trunk, face and limbs. Some are papular while others have a central clear vesicles. There is a scabbed/crusted over lesion on the back. There are less than 50 lesions entirely. No labs were done. It was unknown if medical attention was sought. The patient recovered. Additional information is not expected.
16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first dose of Moderna COVID-19 vaccine/she was only 16 years of age at the time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received.Second dose info received
Enlarged supraclavicular lymph node.  Received vaccination 12/21/20, developed 12/28/20 a 3cmx2cm palpable and visual enlarged lymph node on the left mid clavicle.
CHECKED MY INR VALUE (BECAUSE I TAKE COUMADIN) IT WAS OVER AN 8. I LET MY INR TEAM KNOW THAT I GOT THE COVID VACCINE. I WAS GETTING RED SPLOTCHES ON MY SKIN. BRUISING VERY EASILY. CAPILLARIES WERE RUPTURING. I ACCIDENTALLY CUT MY SELF SHAVING. TOOK 3 DAYS TO STOP BLEEDING. IN THE INTERIM, I STARTED TO EAT LEAFY GREENS AND TAKING VITAMIN K.  THAT HELPED.
High Fever - 105's possible 106 degrees, shaking, shivering, vomiting, headache for 16+ hours