chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Seizure) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  Company comment:  This spontaneous case concerns a 72  year  old male patient, with no medical history reported, who received a dose of mRNA  1273 original vaccine (reported as second dose of his COVID  19 vaccination schedule) and experienced the unexpected, serious (medically significant) AESI seizure. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient had one event of seizure. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735528 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735528:Bivalent case
Patient developed site injection (left arm), then headache, body aches, joint pain, and dizziness
More than 2 years between Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported, more than 2 years between shingrix, which led to lengthening of vaccination schedule.
Burning itchy skin in upper arms and thighs. It is not constant burning itch accompanied by small bumps. It will switch back and forth from arms to thighs and is very uncomfortable. Not even Benadryl or aloe vera will make the itch stop.
Fever, chills, aches and pains all over body and very sore at site!
My two Moderna vaccinations were painless and uneventful. When I got the Moderna booster, there was a sudden severe pain inside my arm when she stuck me.  I've never felt anything like that with any injection in my entire life. it made me jump, and I never move during injections. Ever since then, I've had bad arm pain.  It's a severe ache.  It's been almost six weeks, and it has not diminished.
6AM morning after vaccine face flushed red numbness tingling all over head and forearms were red and burning sensation
Redness and swelling of left upper arm 1 day after vaccine.  Tactile fever.  Prescribed Benadryl.
Fatigue, left arm swelling, left arm pain/soreness, nausea, stomach pain, headache, and severe vomiting
was ill; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was ill (illness), while the patient received  INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
3 seizures, multiple absence seizures for days afterward, strange & uncharacteristic behavior, labored breathing, less responsive, no eye contact, difficulty breastfeeding, screaming, sleep apnea.
Additional information received from the investigator provided patient medical history, hospitalization details, additional vaccines administered, laboratory results, the additional event of neutropenia and an updated relatedness assessment. Information regarding Prevnar was received from an investigator regarding a 3 month old male. On 5/12/00, at 2 months of age, he received his first dose of Prevnar as part of a study. The participant also received a dose of hepatitis B vaccine on the same day. On 6/9/00, he was hospitalized for complications secondary to prematurity and neutropenia. The patient's concurrent illnesses include anemia and neutropenia (reported as: history of cylic neutropenia) with a past history of Klinefelter's syndrome, premature baby (reported as: 28 weeks gestation), chronic obstructive pulmonary disease (reported as: chronic lung disease), neonatal respiratory distress syndrome (characterized by severe apnea and bradycardia both requiring continuous oxygen treatment), patent ductus arteriosus, ventricular septal defect (reported as: small VSD), clavicle fracture (right), sepsis (reported as: rule out sepsis) hypotension, renal failure (reported as: oliguric renal failure), oliguria (reported as: oliguric renal failure), hyperbilirubinemia, patent ductus arteriosus repair (reported as: PDA ligation), feeding problem in new born (reported as: history of feeding intolerance), hematochezia, and sleep study. Indication for Prevnar was immunization. Product was administered on 5/12/00. Dose regimen was 1 dose 1 time per day. The patient also received a dose of hepatitis B vaccine on the same day. Additional suspect vaccines administered 5/11/00 included Acel-Imune, Hib-Titer Vaccine, and Poliomyelitis vaccine inactivated. Concomitant medications were not reported. On 6/9/00, the participant was hospitalized for complications secondary to prematurity and neutropenia. The reporter observed that the participant's neutropenia was first identified on 5/15/00. The participant partially recovered from the complications of prematurity, but the reporter indicated that the patient's neutropenia was ongoing through end of patient's information on 10/20/03. The investigator considered neutropenia possibly related and non-specific reaction not reported to study product. The medical monitor considered neutropenia related to the child's history of cyclic neutropenia first identified 5/15/00 and not related to the study product. The medical monitor assessment for non-specific reaction was unknown. No additional information was available at the time of this report.
8 days after vaccination, in the morning of April 6th, 2021 my left arm started to feel sore and tender around the injection site and there was a small rash forming.  By mid afternoon, the rash had grown to cover nearly my entire upper arm.  The rash burned and itched and was sore to the touch, the skin was raised, warm, and firm.  This rash lasted 3 days and then went away.  The evening of April 11th, I noticed the skin on my upper left arm was warm to the touch again but no rash was visible at the time.  The morning of April 12th, 2021 a large rash appeared covering the majority of my upper arm again.  Same as before, my upper arm was tender and the rash was burning, itched, was warm, firm and raised.  It is now April 13th and the rash is still present, but diminishing.  It is no longer tender or burning but does still itch occasionally.
Monday /p noon- decreased appetite. 130 am T 104.6, Tylenol prior to shot.  Fever until Thurs am. Tues @ 330 T 105, cool sponge.  Arm very inflammed, painful, Knot on arm
night sweats; fever; chills; muscle pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: bnt162b2 (At 12:30, DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 19Oct2022, for COVID-19 immunisation, reaction(s): "General tiredness, sore arm", "General tiredness, sore arm"; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "fever"; MYALGIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "muscle pain"; NIGHT SWEATS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of night sweats, pyrexia, chills, myalgia, headache.  Additional information: COVID did not occur prior to vaccination. Patient did not test for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241827 Same patient, different dose/AEs.;
Experienced vertigo initially at approximately 1030 (stinging at site of vaccination).  After one hour, the vertigo was markedly improved but she had developed chills.  This continues at 1718 at time of this report.
Local swelling, redness 12cmx12cm left anterior/lateral thigh. Suggested ice compress.
This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 03-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H020257, exp. 08-NOV-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, MARRS1311USA011609, MARRS1311USA011610, MARRS1311USA011611, MARRS1311USA011613, MARRS1311USA011614, MARRS1311USA011615, MARRS1311USA011616, MARRS1311USA011617, MARRS1311USA011618, MARRS1311USA011619). Additional information is not expected.
Lot # unknown. On 4/7/21 very tired for 24 hours. But on 4/11/21 experienced extreme fatigue with sore body by late evening temp had risen to 100.5. Temp continued ranging from 99.9 to 101, also experienced body aches, headache, eyes burned, decreased appetite, sweating and chills all continued to 4/15/21. 4/15/21 temp normal but fatigue remained and cough started. Hard cough both dry and productive at times. An ache in the middle of my chest. Had doc appointment on 4/16/21. Temp normal but doc stated my labs were at the levels of someone who had covid but I was covid neg. The doctor suggested my illness was related to the vaccine. I missed a week of work and although I have returned to work I am still experiencing a lingering hard cough.
All symptoms developed approximately 18-24 hours after receiving booster dose: Headache - lasted 6-8 hours. Low-grade fever (101.4) - 4 to 6 hours. Tightness in chest - ongoing  Shortness of breath - ongoing. Cough - dry, non-productive. Occurs every 5 to 10 minutes - ongoing. Nasal congestion - ongoing.
Rash from neck all the way down, all over my body; It's been really severe; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249; expiration date: not known), via an unspecified route of administration in the left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included thyroid (disorder). Concomitant medication included thyroid medication (unspecified). The patient experienced rash from neck all the way down, all over her body; it's been really severe on an unspecified date. The patient gone to the doctor and gave her prednisone. The patient didn't really know whether to take the second shot or not because of this. The outcome of the event was unknown.
A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. It was reported that expired FLUMIST was inadvertently administered, which started on 27-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
The first dose was swollen arm 7 days after shot. Lasted for 2 weeks. The second dose, sore arm, mild fever, hot cold flashes, headache, fatigue, swollen right eye began 36 hours after shot. Worsened slightly over night. Followed by drenching night sweats. Swollen eye persisted 52 hrs after shot.
I experienced severe headaches after my vaccine, located back side of my head, heaviness of pain.  I went to see  after one week and a  CT scan of the head was performed. My CT scan results were normal.  Today I have no headaches.
I woke up on the 23rd and noticed a small section of my right arm was tender and the skin felt hot. Now the next day this hot to touch tender area triples in size (still all above elbow. It's around 4 inches by 3 inches.
Around 5 days after the vaccine my husband broke out in blisters . Different parts of his body.  Had a doctor's apointment that week and we showed his primary dr. the blisters. She prescribed a prescription for Triamcinolone Acetonide cream  for the itch.
Patient arrived under vaccination tent shaking and stated she was nervous. Nurse explained to patient to try and calm down or vaccine may not be administered due to patient moving. Patient did calm down and relaxed arm as instructed. Prior to administering the vaccine nurse explained the procedure and post vaccine instructions. Patient verbalized understanding. While administering the vaccine nurse spoke to patient about hobbies and job to distract patient from the process of administering the vaccine. After administering the vaccine patient stated she felt like she was going to pass out. This nurse called out to staff for help. Patient then went unresponsive. RNs on staff took over taking patients vitals. EMS called. ARNP arrived to scene and assessed the patient. Vitals recorded as BP 105/68, o2 99%, p:74. EMS arrived at 1738. Patient was assessed by EMS staff but refused hospital transport. Patient had an episode of emesis and stated she felt much better. Patient departed at 1752.
Redness at site of injection. Open sore just below the injection. Rash that weeped and seeped on the arm of injection. Rash on inside of wrist and partial rash on face and other arm. Rash was itchy. Lasted 3 weeks.
Received flu vaccine 12/03/2001. Woke 12/04/2001 with numbness left side of chest, by noon this has spread into left shoulder, arm, neck and face.
Mother reported site of varicella injection red, sore.  Next day - 12/21 - "swelled to size of softball".  12/22 - "very inflamed" - saw doctor in emergency room.  Gave steroid shot.  Remains on Prednisone 20 mg vial for 5 days.  Swelling, inflammation decreased 12/26/07.
BREAKTHROUGH COVID: PT FULLY VACCINATED. Pt reported spouse tested positive,reported having a fever and cough. It's noted that the patient uses a BiPAP when he sleeps at night. He denies any chills, SOB, chest pain, abdominal pain, nausea, vomiting, diarrhea, headache and dizziness. Pt diagnosed acute on chronic, hypoxic respiratory failure, COVID-19 viral pneumonia, community-acquired bacterial pneumonia ,obstructive sleep apnea, Cardiac dysrhythmia, Possible zoster exacerbation and Acute kidney injury. Pt treated with Decadron, azithromycin: 500 mg, cefTRIAXone: 1 gm,IV Solu-Medrol, amd heparin t.i.d.
10/31/08 Received FLUVIRUS on 11/11/08 noticed bilateral lower extremity muscle pain. 11/12/08 additional muscle pain in upper left extremities. 11/13/08 felt feverish, chills, muscle pain continue. 11/14/08 no fever/chills but had significant muscle pain in arms and legs, called PMD, Doctor instructed to discontinue PRAVASTATIN 40mg and take 2 ALEVE every 12 hrs. 11/15/08 muscle pain decreased with ALEVE but developed severe weakness hands/finger. Seen by PMD 11/16/08.
Information has been received from a physician concerning an 80 year old male patient who on 16-AUG-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (Lot # 658085/0882U). Concomitant therapy included anticoagulant medication (unspecified). The physician stated that the patient received zoster vaccine live (Oka/Merck) last year and still has a red circular area that bleeds at the injection site. During an office visit on 08-May-2008, the patient told the physician that "one month after vaccination," on approximately 16-Sep-2007, a red area developed on his left arm. The red area bleeds periodically. The patient identified the area as the injection site, but the physician feels it is at a location that would not normally be used. The physician has a picture of the lesion and performed a biopsy (results unspecified). No other information was reported. The patient's bleeding and redness at the injection site persisted. No product quality complaint was involved. Additional information has been requested.
I experienced severe coughing fits where I was unable to breath. I couldn't sleep at night. I did this for a couple of weeks, saw a doctor and they put me on albuterol, Symbicort, cyriba, Flovent inhalers. After being on all those things I eventually started feeling better and that took about a month and I'm still on all those medications now.
This spontaneous report was received from an approximately a 62 year old female project manager (healthcare worker) regarding herself. There was no pertinent medical history. Current conditions of the patient included vein swelling and redness during the infusion of LEVAQUIN intravenous (manufacturer unspecified), fully body rash to penicillin (manufacturer unspecified), periorbital edema to Sulfa (unspecified) (manufacturer unspecified), fever and shortness of breath to Macrodantin (manufacturer unspecified), subcutaneously. Concomitant therapies included BYSTOLIC and ramipril. On 21-AUG-2013, the patient experienced slight sw3elling that was not painful and erythema at the injection site. The patient did not seek any medical attention. No treatment was given. No lab tests were performed. The patient was not recovered from slight swelling that was not painful and erythema at the injection site. The relatedness for slight swelling that was not painful and erythema at the injection site was unknown for ZOSTAVAX. This si one of the two reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of rash scaly in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash scaly and erythematous rash. On an unknown date, the outcome of the rash scaly and erythematous rash were unknown. It was unknown if the reporter considered the rash scaly and erythematous to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a patient that received their first dose of SHINGRIX about 62 days ago still had a red scaly rash on their left arm from the initial dose. No further information was available at the time of report.
redness & swelling on 2/3  of upper arm & shoulder; approx 2 hrs p/vax; APAP given 12noon; (T100.5 R); sl discomfort only;
Patient brought in a letter 3 days after the vaccine had been given, stating that she had some pain, redness and swelling at the injection site 2 hours after injection. Later in the day, she states she experienced fatigue and a fever. By the next day, she states her fever and fatigue was less, and by day three, it was gone. Today, a week later, patient reports no issues at all.
FEVER 101+, CHILLS, MUSCLE ACHES, NAUSEA, EXTREME FATIGUE, MUSCLE PAIN AT INJECTION SITE EMPLOYEE HAD RECENTLY HAD COVID ILLNESS
Day after injection given, c/o not feeling well; pain, redness, swelling in muscle where vaccine given, headache, shivering, feeling tired, weak--could hardly walk at times, hands, fingers, toes and feet hurt was in bed most of day. Temp 98.3 pulse was irreg. Next day felt somewhat stronger, not as tired or as achy. Took Hydrocodone several times which helped for comfort some.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EH9899), on 14Jan2021 as dose 2, single (Lot number: EK9231) and on 01Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Rash about 2-3 inches in diameter with redness and itchiness at vaccine site 7 days post-vaccine.
See in our office 3/17/04 for rash presumed varicella- Major case of varicella by doctor.