chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager and nurse practitioner, regarding multiple unspecified patients (age and gender not provided). Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, multiple unspecified patients received doses of VARIVAX (Merck) (route, lot number and expiration date were not provided) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
! hour adn 45 minutes after getting the vaccine, my arms and legs broke out in a red, tichy burning rash. After 3 minutes it stopped burning, after 10 minutes it was completly gone on it's own. I have Zyrtec in my so maybe that helped. I have been dealing wtih itchy skin and ezcems my whole life but this rash was defintely due to the vaccine.  WHEN I WENT BACK FOR THE SECOND DOSE, THEY WOULD NOT GIVE IT TO ME. THEY SAID IT WASN'T SAFE FOR ME. I TOLD THEM THAT I THINK I HAD COVID IN JAN OF 2020 BUT NOT SURE AND THEY SAID THIS SHOT COULD HAVE ACTED LIKE A SECOND SHOT SINCE I MAY HAVE ANTIBODIES IN ME.  ?? DO YOU AGREE I SHOULD'NT HAVE IT? PLEASE LET ME KNOW.
pt recv vax 14AUG96 & 15AUG96 a small area of redness was noted around inj site (rt leg);redness cont to inc in size;16AUG96 rt thigh was warm to touch/inflamed w/approx 4x5cm of redness;
did not feel well for 10 days; migraine; arm hurting; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well for 10 days), MIGRAINE (migraine), PAIN IN EXTREMITY (arm hurting), CHILLS (Chills) and PYREXIA (Fever) in a 60-year-old female patient 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 MALAISE (did not feel well for 10 days), MIGRAINE (migraine), PAIN IN EXTREMITY (arm hurting), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MALAISE (did not feel well for 10 days), MIGRAINE (migraine), PAIN IN EXTREMITY (arm hurting), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-116606 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added events, updated event outcome
Woke with fever at 11:30 PM on 3/5, still feverish at 7:30 AM on 3/6, but fever gone by 10:30 AM that morning.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates doses of GARDASIL (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experience had been reported. This is one of several reports from same reporter. Additional information has been requested.
No symptomatic side effects reported. No additional AE details or PQC.; Inbound call from HCP reporting a patient was inadvertently administered an expired dose of MMR-II.; Subcutaneous injection formulation administered by other route; This spontaneous report was received from a medical assistant, referring to a 12-month-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant medications included sterile diluent (manufacturer unknown) (lot # T033839), hepatitis a vaccine (+) inactivated (VAQTA) (lot # W002894), varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U022320) and influenza vaccine (FLU [INFLUENZA VACCINE]) (lot # 57R2C).   On 21-NOV-2022, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T037030, expiration date: 03-NOV-2022) intramuscularly at right lateral thigh for prophylaxis (strength was not provided) (expired product administered; incorrect route of product administration). Physician addressed with parents. The vaccine was not available to return, as it was single use. It was also reported that the vaccine was discarded. The vaccine was used according to the instruction. The operator was trained. No symptomatic side effects were reported. No additional adverse event (AE) details or product quality complaint (PQC) (no adverse event). The outcome of event expired product administered was recovered.
Patient developed a large knot and redness at injection site.  Patient was advised to monitor the area for changes and to see his medical provider if the area worsened/expanded over the next couple of days.
Tingling in legs, dizziness and nausea.  Dizziness and nausea resolved on its own after 3 days.  Tingling has progressed to cramps, muscle contractions and fasciculations.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider 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 07-JUL-2015, a physician administered ZOSTAVAX, (lot # and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On 14-NOV-2016, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm/ arm soreness pain increased), HEADACHE (headache), PYREXIA (increasing fever) and VACCINATION SITE SWELLING (bumps appearing on his body that come and go away) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (increasing fever). On 02-Feb-2021, the patient experienced VACCINATION SITE SWELLING (bumps appearing on his body that come and go away). On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm/ arm soreness pain increased) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL FORTE) from 01-Feb-2021 to 02-Feb-2021 for Fever, at a dose of 1 dosage form. On 02-Feb-2021, PYREXIA (increasing fever) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm/ arm soreness pain increased), HEADACHE (headache) and VACCINATION SITE SWELLING (bumps appearing on his body that come and go away) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Pyrexia: High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash on the site of vaccine injection (measure 7.5cm x 7.5cm)
I got a Shingles vaccine to keep from getting Shingles and immediately got Shingles after getting the vaccine. I have been receiving treatment for Shingles since May 07.
fever immediately p/vax-diarrhea, ulcers on diaper area;chronic digestive problems, loss of speech;stimming behavior;low IGA;high IGE;antibodies to myelin basic protein-autism, sz disorder; Per follow-up dated 10/5/00, the pt underwent terminal illness biopsies of live measles virus in 12/99. The pt's ulcerative colitis and gastritis are currently under the care of a physician.
local rxn immed;then 1 wk later h/a,myalgia,intermittent fever throughout noc & into next day,then resolved;
Patient stated 2 hours after vaccine, swelling of arm from shoulder to elbow, red, pain running do arm occurred. Couldn't lift arm.
Pt COVID 19 Vaccination Card has incorrect date of 4th COVID booster, verified in Immunization Registry. Vaccination card date 07/13/2021, in registry 07/13/2022.   Pt has history of immunocompromising medical diagnosis. 5th Booster administered as recommended by CDC guidance. 5th booster administered too early according to date in Immunization Registry.
Pt came in on  8/3/13 complaining of itchiness and little pain. I checked her left arm (upper) there was a red spot measures 2 inches x 14 1/4 inch with a lighter circle in middle. It is warm to touch. Pt said it is worse today.
Twenty-seven year old without significant medical history ten days post smallpox vaccination complained of global headache (pain 6/10), myalgias and chills.  Physical revealed a well appearing afebrile male with mild dehydration and normal HEENT, cardiopulmonary, abdominal and neurologic examinations.  Patient managed conservatively with IV fluid hydration, NSAIDS, ascorbic acid and limited activity.  On post vaccine day eleven members headache intensified to 8/10 with worsening chills and fever of 100.6.  Patient was nauseated but denied emesis.  Pertinent negatives included normal fundi, no focal neurologic deficits or meningeal signs.  Laboratory analysis showed elevated WBC count of 14 and CRP of 14.  Member was sent home on bed rest with close follow up the next day.  On post vaccine day twelve headache characterized as 10/10 with positional component, photophobia, neck stiffness, fever, chills, nausea and myalgias.  Exam revealed ill appearing male febrile to 101.5.  HEENT within normal limits.  Fundi without papilledema or venous pulsations.  Neck was supple.  Cardiopulmonary and abdominal exams unremarkable.  Neurologic exam revealed intact CN function and no focal deficits.  Deep tendon reflexes were 2+ throughout.  Kernig and Brudzinsky signs absent.  Given the temporal relation of symptom onset/progression with vaccine administration, the decision was made to transport patient from military clinic setting to host nation ED for neuroimaging, lumbar puncture and Neurology specialty evaluation with presumptive diagnosis of post vaccine encephalitis.  Non-contrast CT revealed no evidence of intracranial hemorrhage or increased pressure.  Neurology staff decided against lumbar puncture to rule out other etiology.  Presumptive diagnosis was made: post vaccine encephalitis.  Patient was discharged from ED with close observation by medical treatment facility.  On post vaccine day fourteen member experienced marked improvement of symptoms.  Headache now 4/10 without positional component, no photophobia, neck stiffness or fever.  Member still complained of myalgias.  Exam normal.  On post vaccine day fifteen headache resolved.  No further symptoms.  Member was back to flying status post vaccine day twenty-three.
Pain at injection site and fatigue the same day as the injection. Headache, body aches, menstrual cramping (not on period), fatigue, chills, sweats throughout next two days
In 2021 I began retaining fluid in my ankle and I was out of breath with activity. I had dose 1, 2 and 3 in 2021. In January I had my annual cardiologist appointment. They performed an echo cardiogram, ultrasound and stress test. They found that I had blood backing up in my heart at this time. However, in July of 2022 at my next cardiologist appointment they found that my left upper ventricle was enlarged.
After 10 minutes of receiving my 2nd shot I began to feel a tickle sensation in my throat and started to cough. The cough became stronger and harder for me to breath. The lady who gave me the shot took me next door to the urgent care where the doctor told me he could hear the tops of my lungs closing.  Within minutes. The Dr told me had I waited any longer I would have had a far worse outcome. They gave me several different types of medications there and it stopped the coughing.
Swelling, erythemia, warmth, induration starting right after injection 5"x7"cm. Temperature 48 hours after injection. Benadryl 50 mg PO QGH PRN; R 20 min, QID
Pfizer BioNTech vaccine for 5-11  formulation (orange cap) was given to a patient age 12 years old resulting in a lower than authorized dose
Headache, Myalgia, Fever, NauseaVomiting, chills; fever; aches; headache; nausea Narrative: Tylenol and Ibuprofen as needed
My 2 month old baby went for his 2 month check up and to receive his 2 month vaccines, DTap, Hep B, Polio, HIP, PCV13. After my baby received all 4 Shots it was about 2 hours later that he started crying uncontrollable. I tried nursing him but he did not want to. My baby was crying so hard like he was in a lot of pain. Nothing we tried worked, we would put him down so we did not touch his legs were he got the shorts but he would continue crying where he had trouble breathing. I called the pediatrician to let them know and while I was on the phone the nurse could hear my baby in the background screaming, she informed me that if I can't smooth him that I need to take him to the ER. They had no advice for me.  My baby continued crying uncontrollably for about 4hours before he finally fell asleep from pure exhaustion. Since he received his shots he has moments where he bursts out crying for no reason, and hates being flat on his back, it's like he is in pain.
101.1 fever in AM on 2/26 and intermittent dizziness through out the day. Chills, body aches, fatigue began late morning and progressed into the evening. Did not have access to thermometer but husband confirmed I was burning up to the touch. Took Tylenol around 8pm. Became clammy with sweats around 10:00pm through the night.  On 2/27, fever appeared to be gone as well as other symptoms other than slight fatigue.
Left shoulder pain since a couple days after the vaccine was given. I did expect some soreness but it has been 3 weeks and my left shoulder is still very sore. Have been using Advil sporadically but at advice of my doctor's nurse I will begin a course of Advil for several days to find out if this will remedy the situation. Have limited mobility with the arm and when I do use the arm I usually experience moderate pain. It is difficult to get comfortable in bed at night due to the shoulder pain. Thanks. PS:  Not sure that there is any other explaination for the shoulder pain but thought I should report it.
Muscle soreness following the shot, then it began getting more and more painful. ROM became limited 5-6 days after. Muscle strength has decreased.
GBS is reported in pt who recvd flu vax; unk it pt recvd flu shot in past; 2 wks p/flu shot pt had laparoscopic cholecystectomy & during recovery devel paresis w/bladder incont;
Patient reports having chills the night of the vaccination. The next day, she reported having pain radiating up and down her arm . Her arm was swollen and bright red.
The day after the vaccine, 09/14/2022 started feeling a slight fever and chills. Took a COVID-19 PCR test - Positive. Wife tested positive for COVID-19 the same day I was vaccinated. Prescribed Paxlovid. Haven't been retested yet.
Sudden bilateral leg weakness a little over 2 weeks from vaccine dose. Also had the inability to walk. Bilateral increasing numbness to both arms and legs. Progressive weakness. Admitted to hospital. Had CT scan, MRI scan, LP puncture, blood work. Findings/lab work state GBS (Gillian Barre syndrome)
Numbness; Tingling; My left arm and left shoulder blade are swollen and they are sore; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient reported himself who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in Arm Left on 11Mar2021 (Batch/Lot number was unknown) as SINGLE for covid-19 immunization and was administered at hospital. Medical history included ongoing elevated cholesterol. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) taken for elevated cholesterol, at a dose of 10 mg, tablet once daily from unspecified date and stop date were not reported. Consumer stated, he was calling to report a side effect from Pfizer COVID Vaccine that  received 13 days ago (Clarified as 11Mar2021) In the arm it was injected. On 11Mar2021, left arm these symptoms continue right to this day, there was numbness, tingling, left arm and left shoulder blade are swollen and they are sore, there was a level of soreness. The patient's second shot was due on 08Apr2021. On 17Mar2021 (last week), patient's blood drawn for a lipid panel profile, and the results were fine. Patient did not received treatment for AEs. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
LEARNING TO WALK AGAIN FOLLOWING RARE VACCINE-RELATED REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced learning to walk again following rare vaccine-related reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from learning to walk again following rare vaccine-related reaction. This report was non-serious.
Edema, Elevated BP despite continuing BP medications, Pain to feet and legs, Shortness of breath,
Robust take with autoinnoculation to arm around vaccination site (left arm) and left chest wall
Patient fainted upon administration of Tdap. He had already received a meningitis injection. He was passed out approximately 4-5 minutes. He was alert but groggy about 5 more minutes. He had a sweaty forehead but no fever nor clammy skin. Alert > 5 minutes.
Menveo reconstituted with sterile diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 20th August 2022, the patient received Menveo. On 20th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received a dose of Menveo and dose was reconstituted with a sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose had not been repeated.  The reporter gave permission for follow up but did not wish to share last name. The reporter consented to follow up. Additional supportive information: The patient received a dose of Menveo and dose were reconstituted with a sterile diluent instead of the supplied CYW-135 diluent, which led to wrong solution used in drug reconstitution.
Reddened area app 3" around injection site. Started with shoulder pain in evening worsening during night. No better no worse this am.
Tested positive for COVID-19 on 01/23/2022. I had chills, runny nose, sneezing, body aches, coughing, fever, I called my Physician on 01/24/2022  I took  OTC medication for my symptoms. However I have lingering COVID-19 symptoms specifically joint pain in my ankles/hands and brain fog to date.
Within about 24 hours of getting the shot, I began to feel dizzy. My head felt as if it were spinning and felt worse upon movement, especially bending. The feeling subsided about 48 hours after the initial symptoms.
Within 16 hrs of receiving Flu shot severe muscle ache began and has lasted 6 Days. Within 28 hours High Fever estimated in excess of 102 degrees (Estimate due to hallucinogenic period) accompanied by severe headache, cold sweat, sleeplessness, frequent urination and thirst, duration approx 48 hours. Treatment was unavailable due to out of country on vacation, remained bedridden two days barely able to move due to muscle and joint pain. Doctor scene immediately upon return to military base however, symptoms were dramatically improved by this point. (*) Hospitalization is estimated at two days if one was available. (*) Would have been life threatening if my health wasn't as good as it is. (* Personal Opinion).  Still suffering from muscle and joint pain which improves with continues movement throughout the day. Doctor suggested reporting via this form.
Injection site reaction (pain, tenderness), chills, dizziness and weakness, headache, fatigue, fever
Mother called clinic on 7/5/01, stating that the child was taken to doctor with complaint of "a swollen gland under the arm that shots were given in and complained of pain in the area". Child was placed on antibiotics.
PATIENT CALLED PHARMACY THIS MORNING STATING THAT SHE HAS EXPERIENCED PARTIAL HEARING LOSS IN THE LEFT EAR (SAME SIDE AS VACCINE ADMINISTERED).
Patient received dose #1 of Pfizer's COVID-19 vaccine at 12:12 PM.  While waiting in the observation area, he experienced left-sided chest pain.  C/o of some SOB and diaphoresis.  Reports cardiac history.    Felt somewhat clammy.  Placing hand over left chest area.  VSS.  First Responder called with prompt response.    Immediately transferred in to ED with assist of RN at 12:30 PM.