chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, shortness of breath, light headed, lack of endurance.  Visited doctors (heart specialist & lung specialist), saw no problems but I disagree.
Muscle in shoulder is still very painful. Hard to lift arm over my head. Hard to take off a shirt and make certain motions.
Reports pain and erythema around the injection site of Pediarix few hours after administration. The following day the erythema increased in size with swelling. also developed fever (subjective) reported by the mother. Two days later the redness is about 6 inches in diameter with slight tenderness.
Temp of 101.3, chills,  discomfort in  left arm so couldn't not raise it ....in evening Next morning temp was 99.7 (usual am temp is 97.7)  and felt much better.
Patient returned to the pharmacy on 5/5/19 stated his left arm from the shoulder to his wrist was in pain including chest pain periodically. He stated when he woke up on 5/5/19  the redness, warmth, and swelling at the site of injection had gotten larger from the previous two days. The mark covered his entire arm in a circular fashion.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 06-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 28-JAN-2015, the patient was treated by a physician at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed tramadol and acyclovir for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Large localized swelling of deltoid extending to mid humerus. Started 1 hour post-vaccination. No systemic symptoms. Resolved gradually over 3 days without intervention.
She got her vaccine and within 15 minutes she was having a hard time breathing.  She told her husband that she needed to go to the bathroom and see if she could get the feeling to stop.  She went into the bathroom and she was gasping and choking for breathe.  They got her into the ambulance and her BP was extremely high 128/90 and her BP normally is 98/60.  They started an IV, breathing treatments and oxygen.  She was gagging up saliva and having a hard time breathing.  They got her to where she was calm.  Her body when it is under extreme amounts of stress goes into seizures, which it did.  She then was transferred to  in  for observation.  By the time she arrived her BP had come down and was starting to stabilize.  She was given steroids, discharged home.  She has had problems breathing, extreme/sharp pain on the left side of her head  behind the eye, which has been going on for over a week.  By the end of the day she is exhausted.  She has never had a hard time breathing at high altitudes and  now she can walk up the stairs and be winded.  This has all happened since receiving the vaccine.   She sent a message to her doctor who did seem concerned.   The pharmacist at the facility at the time said that she was fine, to leave her alone.  The EMT's said that there was something wrong with her and took her to the hospital.  The hospital did not give her any long-term medications to take.  She does have a routine APT with her PCP on 4/6/21.   On Thursday she woke up and asked her husband if her face was swollen, and he asked why, she stated that her face was numb, and some spots so sensitive that she could not brush her hair.  This was on the left side.  The sensitivity is still there, but not as intense.
A physician reported the occurrence of an injection site infection in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were unknown. On 06/03/2002 the pt received the 5th injection of Infanrix (lot DTPA552A2). Post-immunization on 06/03/2002 the pt developed "severe" swelling and red streaking in the arm. The area was hot to the touch. The pt was seen by a physician, who noted that a needle smaller than 5/8 inch was used to administer the vaccine. The physician made a diagnosis of injection site infection and prescribed amoxicillin clavulanate (Augmentin). As of 06/26/2002, the outcome of the event was unknown.
an itchy, burning rash on my arms, legs and face.; an itchy, burning rash on my arms, legs and face.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL8983) via an unspecified route of administration on 08Feb2021 at 14:30 (at the age of 66-years-old) in left arm as a single dose for covid-19 immunization. Medical history included known allergies to sulfa and gluten both from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included lisinopril (LISINOPRIL) and atorvastatin calcium (ATORVASTIN) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: EL9899) on 18Jan2021 at 14:30 in left arm for covid-19 immunization and developed minor rash on arms and legs. On the second injection, he was given a dose of benedryal beforehand. He had no immediate reaction. About a week later, as the vaccine was taking its full effect, he had an itchy, burning rash on his arms, legs, and face. He took 2 benedryal and it went away in about 30 minutes. The outcome of both the events was resolved in Feb2021.  Follow-up attempts completed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; vaccine administration date=Oct/2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "former rheumatoid arthritis" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "allergy-induced asthma" (ongoing); "high blood pressure" (ongoing); "Possibly penicillin and sulfas" (unspecified if ongoing); "Possibly penicillin and sulfas" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: May2013; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Feb2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2022, outcome "unknown", described as "vaccine brand other=Moderna; vaccine administration date=Oct/2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive, notes: two Binax brand tests. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with PAXLOVID from 04Oct2023 to 09Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328896 same patient, different drug and event;
pt recvd vax 2 wks prev recvd SC in error 14NOV94; pt was to have recvd tuberculin test but it is believed that pt recvd flu vax instead; pt exp pain immed following the inj & devel erythema @ the inj site;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date.  The provider may have given the dose outside of the 6 hour window after the vial was opened.  No symptoms or signs.  Pt will be contacted and offered to be re-vaccinated to offer full protection, per our Group.
Child inadvertently given Adult formulation of Engerix B- Hepatitis B vaccine.
This case was reported by a healthcare professional and described the occurrence of a body rash in a 31 year old male subject who was vaccinated with hep A vaccine (Havrix) for prophylaxis. Influenza vaccine given on 22Dec05; influenza virus vaccine; given on 22Dec05; polysaccharide typhoid vaccine; unk given on 22Dec05. Concurrent medications included Decavac. On 22Dec05 the subject received a dose of Havrix (dose and lot number not specified). Concurrently on the same date, the subject also received injections of influenza virus vaccine (Fluzone); polysaccharide typhoid vaccine (Typhim Vi) and DeCavac. On 24Dec05, two days after vaccination with Havrix, the subject developed a pinpoint non pruritic body rash. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with Havrix.
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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
After aloha gal remission, alpha gal present. After vaccinations  Reactions resumed to all beef and pork
Fever, chills, headache, achy about 12 hours after shot and last about 24 hours. Took Motrin and Tylenol to assist with symptoms
1st dose 3 years ago, late 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on March 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received 1st dose of Shingrix vaccine about 3 years ago. The patient want to receive the 2nd dose of the Shingrix vaccine. The patient wanted to know about have to restart the vaccine series over. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Mom states child coughed a lot on 28JAN91 & had temp to 102 oral that PM. Took to MD 29JAN91 & started Amoxicillin & Naldelate. Highest temp was 103 oral 29JAN91. Sx improved 30JAN91 temp 99 oral 1FEB91 father states child has recovered.
Pain at injection site for about 3-4 days Red raised circle Itching - severe at times
Member was properly educated and received smallpox vaccine on 11/16/2011. Vaccine was checked with a major reaction on 11/23/2011.  He came to medical on 11/28/2011 with c/o of a small papule under left eye which was covered with a bandage.  Clear drainage, redness, and mild swelling under left aspect of eye.  No treatment necessary.  Educated patient on smallpox aftercare given.
Patient came to the pharmacy to let us know that she had to go to the doctor because the arm was red and swallen. It seems as a celullitis. She received antibiotics (Cephalexin) for a week treatment.
Noticed arm swellon and red with blisters went to drug store hydrocortisone cream and Benadryl. Monday 10/13/14 face, neck and chest swollen and red with blisters on chin. Went to after care was told to continue cream and Benadryl. Did go away on 10/15/14 but blood pressure has been spiking and out of control had to go to Doctor 2 times and ER at hospital by ambulance because of hypertension out of control. Did EKG, chest Xrays, blood work, urine test all negative.
A spontaneous report has been received from a consumer concerning a 1 month old patient of unknown gender, who had been administered Nasal FLUMIST Quadrivalent (Intranasal). FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient was given FLUMIST Quadrivalent at two months old by accident. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of given FLUMIST Quadrivalent by accident was unknown. The report was considered to be non-serious by company physician.
Approximately 24 hrs after injection, a hard reddish lump formed at injection site. it was painful to touch and very hot.
Welts to deltoid area (over ~ 5x6 cm) with mildly erythema base. Given 25 mg Diphenhydramine.
This initial spontaneous report was received from an on-line article that was posted on social media and concerns an unspecified amount of patients who were vaccinated with GARDASIL. The article mentioned that the GARDASIL vaccine causes autoimmune problems that cause sudden debilitation and/or death. It was also noted that to date, it was believed that GARDASIL was responsible for the death of 121 young women (cause not specified) and for 57,520 reports of adverse events obtained by the Vaccine Adverse Events Reporting System (VAERS).  All of the events were considered related to GARDASIL. Upon internal review, autoimmune problems and death of 121 young women were considered to be medically significant. Autoimmune problems were considered disabling. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-0807USA02497:; Reported Cause(s) of Death: death; autoimmune disorder.
Patient received Flublok vaccine prior to her 18th birthday.  Immediately notified the patients provider who discussed vaccination error with patient.  A call was placed by nursing staff to Clinic head of pharmacy.  Pharmacy contacted Flublok manufacturer Sanofi Pasteur, for guidance. Information received from manufacturer was that patient is at no risk from increased harm due to receiving vaccine before turning 18 yrs old.  Informed to watch for standard influenza vaccine side effects and symptoms.  Manufacturer representative requested a VAERS event be reported.   No adverse reaction or events noted or reported by the patient.  No treatment required.  Patient's EDD 4/11/2020.
Exacerbation of ulcerative colitis.  Diarrhea (watery stools), abdominal pain, gas, cramping, blood in stool.  Mesalamine dose was increased when symptoms were reported 2/9/21.  Patient did not have relief with this so was given a course of Prednisone 2/12/21.  He did not have improvement after the first 4 days of this and was scheduled for flexible sigmoidoscopy.
Pt died of distributive shock and multisystem organ failure on 10/26/02.
Chills, low grade fever, weakness and fatigue, body aches, headache for two days after the shot. Took Tylenol every 6 hours.
Compensating to the point that he can't even walk barely; Not doing well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 89 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 13Feb2021 (Lot number: EL3249) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Pace maker" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (1 st dose), administration date: 23Jan2021, when the patient was 89 years old, for Covid-19 Immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Feb2021, outcome "unknown", described as "Compensating to the point that he can't even walk barely"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Not doing well at all". Therapeutic measures were not taken as a result of gait disturbance, malaise.  Additional information: Reporter stated, "Well I am calling on behalf of my father he is (Name withheld) he is having some side effects he had from his second vaccine on 13Feb2021 and he is just not doing well at all, he is compensating to the point that he can't even walk barely."  No follow-up attempts are possible. No further information is expected.
Raised red welt around site of injection, swollen, painful upper arm and arm-pit, difficult to move arm. Head-ache. Low-grade fever. Sore throat. Exhaustion. These symptoms persisted through Sunday night (09/09/2012 10pm). The arm stopped hurting after this point, but I still have had symptoms of a (bad) common cold all week long (it is 09/15/2012 today).
Pt was given Pedarix and IPV so received extra dose of polio. No adverse reaction. Parent called and updated. to monitor. Provider informed.
This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored doses of PEDVAXHIB intramuscular injection, for prophylaxis. (Strength, route, dose number, lot number and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013215: US-009507513-1612USA011668.
This case was reported by a lawyer and described the occurrence of autoimmune disorder in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a legal complaint: The subject received LYMERIX (GlaxoSmithKline) given on 26 April 1999 and 27 May 1999. On 27 April 2000 the subject received the 3rd dose of LYMERIX (unknown). In 2009, nine years after the third vaccination with LYMERIX, unspecified testing revealed moderate decrease in cerebral cortical perfusion in a heterogeneous pattern. Based upon the same testing, the subject was also "potentially diagnosed" with white matter changes of the brain. In 2010, he was diagnosed with "post Lyme vaccination autoimmune syndrome". The complaint alleged that the subject had been "misdiagnosed by a multitude of physicians on multiple occasions" until 2010 when his physician "drew a connection between his condition and the LYMERIX vaccine". The patient was reported to have sustained "serious personal injuries and related losses" including "post-Lyme vaccination syndrome and/or treatment resistant Lyme arthritis", requirement for healthcare, medical and related expenses, mental anguish, physical pain and suffering, diminished capacity for enjoyment of life, diminished quality of life, diminished ability to work, and other losses and damages. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Starting around 5 pm on day of vaccine I started getting a low grade fever and it continued through the next 24 hours. I took 2 500 mg Acetaminophen around 10 pm and went to bed. During the night I had some cold sweats and did not sleep well.  The next day, I had chills and some body aches. I too 2 500 mg acetaminophen two more times during the day. I was fatigued with some body aches throughout the day. The next day was very similar to the 2nd day after the shot but no fever.  It is now the 4th day after the shot and I feel back to normal.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H015863, expiration 24-FEB-2015) (dose unknown), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
I tested positive with COVID on 10/3 of last year, lost my taste and smell for about two and half weeks. I got my first vaccine 91 days post COVID on Dec 30. Around February 16, I started developing blood clots in my leg, it started in my left and the next day it was in both lower legs. I went to the ER and my prior doctor advised to take aspirin and rub ointment on it, after a few days I was still hurting, called my doctor and went to have MRI, discovered they were surface clots, I was placed on Eliquis, my doctor's opinion was that it was not from vaccine but a side effect of having COVID, took Eliquis for 30 days and no longer have blood clots.
excessive sleepiness x 5 days according to mom's history; was more difficult to awaken for feeding; this reaction only reported to clinic @ 4 month visit 2AUG93;
PATIENT WAS GIVEN PFIZER VACCINE FROM PREVIOUS DAY. STAFF MEMEBER DID NOT PAY ATTENTION TO DATE AND TIME IT WAS OPENED.