chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving my 2nd dose on 1/22, my arm started to feel sore about 4hrs later. Around 1AM on 1/23 I  began to experience chills, and a fever (I took nothing to treat my symptoms at the time.) Around 8AM I my muscles began to ache all over. I still was having the fever and chills. This all continued until noon when I decided to take some NyQuil and apply Bengay. Around 4pm, the fever was broken and my muscles did not ache as they did before, my arm was not as as sore. This was not a fun experience.
Pt developed erythema, mildly increased warmth, induration and hives on left leg at site of IPV injection.
Rash, erythema multi-form, child irritable scratching at the rash under her chin. No fever at this point, eating well and acting normal. Physician recommends no more MMR vaccine be given to this pt.
Redness at injection site, 2 whelp-like areas tingling-called Dr.-he said BENADRYL 25mg-We gave her an ice pack-She went home and took 25mg BENADRYL-her husband is home too. She will take more BENADRYL it needed and will seek EMS if SOB-increased reaction.
no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007597: US-009507513-2103USA007896:
Initial unsolicited report received from a physician on 05 November 2015. This case was linked to 2015SA179115 and 2015SA179116 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date in 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient died. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The outcome was fatal. List of documents held by sender: none.
After first dose restless legs, insomnia and testicular pain and sensitivity. After 2nd dose, severe tinnitus, returned testicular pain and sensitivity, migraines worse
Booster dose received on 12/3/21. Early next morning there was worsening pain @ inj site followed by blisters 24 hrs later that worsened by 12/5/21 until they popped pm 12/9/21. Seen today by cardiologist and mention the site to the FNP. She recommended that I contact you. Today the blistered area was scabbed over about size of a quarter with dark black skin (which I have now removed). Still very painful as well as the injection site. Vaccine received at pharmacy. Lot number FJ8757. I do have pictures as well
Severe body aches,  chills, nausea, malaise, headache. Took Tylenol around the clock. Resolved in one day
Patient contacted pharmacy on 10/16/20 stating that she had red rash-like bumps on both arms down towards wrist that started at the injection site. On night of vaccination, patient had gagging/coughing issues and the day after felt like she "got hit by a truck". On Friday, she called to report reaction and was confirmed no issues with breathing/swelling. Patient was advised to take allergy med and visit MD ASAP. Patient visited urgent care next day and was prescribed steroid to help with rash.
This spontaneous report was received from Physician via a Healthcare worker referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. No product quality complaint (PQC) was reported. On an unknown date, the patient experienced "severe reaction". The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. This is one of two reports from the same reporter. Additional information has been requested.
Mild itching that started within 20 minutes of injection that I thought was a result of my sweater material.  But itching increased over a couple hours of time even after changing clothes.  No rash on body.  Just itching all over.  Benadryl helped calm itching  and it finally started subsiding around 4 hours later.
Deep muscle ache and stiffness in upper legs; buttocks the worse and arms, hands and feet. Fatigue.
This spontaneous report as received from a registered nurse refers to a 21 years old female patient. 5 years ago approximately on 2007, the patient passed out immediately after administration of her first 0.5 mL dose of intramuscular GARDASIL injection (lot# not provided). The patient recovered in the office without requiring treatment. There were no laboratories performed. Upon internal review the event passed out was considered to be medically significant. The relatedness of the event with GARDASIL was not provided. Additional information is not expected.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 05-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
came in contact with covid positive person. woke up with sore throat and coughing. tested positive. was down for 3 days not feeling well with coughing, sore throat, runny nose, fatigue, sore muscles. missed 7 days of work because the cough wasn't subsiding although other symptoms had gone.
weakness on right side slurred speech too start. Now having  spells i can fill come on last about 10 seconds cant walk or talk during them.
A little blister; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (A little blister) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced BLISTER (A little blister). At the time of the report, BLISTER (A little blister) had not resolved.
This spontaneous report was received from a registered nurse referring to some patients of unknown age and gender, that were vaccinated, on an unknown date, with a dose of VAQTA, (dose, route of administration and lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the VAQTA was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
I woke up with petechiae on 5/10. By 5/11 the petechiae developed into thrombocytopenia purpura with a platelet count fo 1000, including mouth lesions and prolonged mucosal bleeding. Admitted Hospital for treatment on 5/11. Treatment included a high dose of oral dexomethasone for four days, IVIG transfusion for two days, and a single platelet transfusion. Fluid developed in the lungs, but that was determined to be a byproduct of treatment, and not part of the adverse reaction. By the time of discharge on 5/14, platelet count had risen to 88000. One week later at outpatient, platelet count had risen to 180000.
RPh gave vaccine to patient.  Patient passed out shortly after.  Her boyfriend was there and allegedly caught her as she fell off the chair.  Patient was then laying on the floor.  RPH called 911.  EMS arrived shortly after and took her to hospital via ambulance.
1MAR93 recvd 3rd vax that noc pt devel hives that lasted 3 days;
Patient became anxious and upon assessment patient described as ?room is black.?   Paramedics over to access at 1112.  1114 vital signs 82/47 BP, 75 HR, 98 on RA.   Blood glucose 113. Paramedics gave 500ml Bolus of NS, BP now 112/74.  Patient declined transport to ER,  will have wife take him.
24 hours later 3" diameter red and hard - upper left arm swelling, rash on back of shoulder blade, increased in size extending to shoulder area throughout day. Started resolving 72 hours later but has walnut size know still 1 week later.
2MAY91 p/receiving immun, pt had sz-like episode, t105.2 in AM; Seen in ER & released later in PM, MD decided to hospitalize pt for observation; Remained hospitalized because of inc temp-released 5MAY91; Hlth condition same as prior to vax;
On February 14th I experienced a Transient Ischemic Stroke (TIA).  I was admitted to Emergency - Medical Center for treatment, testing and observation.  I was released the following afternoon (Feb. 15) upon completion of testing.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three-months-old male patient who received a 0.5 ml first dose of PENTACEL lot C551CAA via intramuscular route in the right thigh and 0.5 ml first dose of DAPTACEL lot C5254AA via intramuscular route in the left thigh on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; HEPATITIS B VACCINE for Immunisation; and PNEUMOCOCCAL VACCINE for Immunisation. It was a case of actual medication error due to extra dose administered as the patient received PENTACEL and DAPTACEL on the same day. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Pediarix given 5/27/04 running high fever first 24 hours after shot. Seizure 5/28/04 temp 101.7 to 102.3 ER diagnosed with febrile seizure. June 9 2004 seizure #2 temp 100 - 101 taken to ER. Seizure #3 July 22 and taken to ER. Seen by Neuro MRI. EEG recommended no further pertussis vaccine started on Phenobarbital.  6/5/07 Received records from PCP which reveal patient seen 7/22/04 s/p seizure & visit to ER that day.  Being w/u for seizure disorder.  Seen again on 7/24 for diarrhea.  Vax records included do not include Lot numbers. Next note is from neuro clnic on 11/15/05.  Noted to have had last seizure on 11/9/05 & was febrile at that time, 103.  Seen in ER that day & d/c on same anticonvulsants but labs revealed subtherapeutic & dosages changed. FINAL DX: symptomatic seizure disorder secondary to pertussis vaccine; s/p febrile seizure status epilepticus; expressive speech delay. 9/28/07 Reviewed hospital medical records of 5/17/2005-8/22/2007 which are outpatient medical records and reveal patient experienced developmental delays esp language delay since 5/2004.  Hx states was in good health on day of vax 5/2004 & developed fever that evening & had seizure.  Had multiple subsequent episodes of status epilepticus usually associated w/fever.  Speech very limited, able to follow commands & drools excessively.  No psychosocial isolation.  Mildly hyperactive.  Multiple dietary concerns, weight below 3rd percentile.  On multiple antiseizure meds.  Motor skills were near age appropriate level.  Below age level on language both auditory & expressive.  Referred for early intervention services. FINAL DX: seizure disorder s/p AE to DTaP; cognitive delay, expressive & receptive language delay; mild adaptive delay; motor skills age appropriate. Epilepsy - Currently on orti-epileptic Tegretol.  Also has developmental delays.
she woke up around 4:30-5:00am this morning with right sided chest pain; tingling in her body including her feet/Right arm was very numb and tingly/Tingly and numb all over head and face; her head feels numb/ Tingly and numb all over head and face/Right arm was very numb and tingly; her lips feel like she has had novacaine; having some arm pain later that evening; Had a little headache; This is a spontaneous report from a contactable consumer (Patient).   A 73-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 73-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received first dose of BNT162B2 for covid-19 immunisation. Patient reported she had a little headache and some arm pain later that evening (on 29Mar2021) for which she took Tylenol PM. She states she woke up around 4:30-5:00am this morning (on 30Mar2021) with right sided chest pain, tingling in her body including her feet, her head feels numb, and her lips feel like she has had novacaine, right arm was very numb and tingly and for tingly and numb all over head and face. As a therapeutic measure patient took Tylenol PM for some arm pain and headache. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Later that evening after the vaccine I developed a low-grade fever. My joints began feeling like they were on fire and my muscles were cramping severely. My fever continued to rise throughout the night. On Saturday I was out of it and my temp elevated to 105 associated by uncontrollable sweats and chills. My muscles and joints continued to feel like they were on fire, so my husband reached out to my PCP and the pharmacist, both of whom advised I take an Ibuprophen to try to get a little relief.  About 7pm I took Ibuprophen and a few hours later I started sweating profusely but was able to finally get a break at this time and was able to sleep. About 12AM the fever finally broke. The next few days later I was really lethargic and was hard for me to get out of bed and do anything and after about that Thursday I begin getting a little strength back and started feeling a little better and after about a week or so after I was back to feeling myself again.
Patient presented to Hospital on 9/1/2021 with complaints of fever, weakness, headache, and malaise.  He was recently hospitalized at hospital on 8/27-8/29/2021 for Covid-19 viral infection with associated general weakness and mild encephalopathy that resolved, mild COPD/asthma exacerbation, leukocytosis worsened with steroid-induced therapy, and mild renal insufficiency.  He was discharged on oral prednisone and Levaquin for 7 days.  He was recommended to continue isolation precautions through 9/4/2021 and follow-up with his PCP in 1 week.  The patient had no complaints of illness or discomfort on Sunday and Monday.  However, when he awoke on Tuesday (8/31/21)  morning he had a fever of 102 and a pounding headache.  He felt weak and dizzy.  When he awoke on Wednesday (9/1/21) he continued to feel the same.  He presented to Hospital outpatient services for Casirivimab-imbevimab 1200 mg infusion.  During that time he was afebrile with T-max 100.0 and vital signs were stable.  Wednesday evening at home, he developed a recurrent headache and febrile conditions.  He then proceeded to call EMS as he was unable to get out of his chair.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014402 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
5-6-10- Rec'd MMR VARIVAX and HEP A (all separate inj). 5-12-10 went to an urgent care with fever. Dx immuniz related. 5-14-10 Seen our (PCP) office fever/rash ? vaccine vs roseola. 5-15-10 Went to UC. Dx. Vaccine reaction and O.M. given steroids and antibiotics.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt was ambulatory but got lightheaded for about five minutes
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
Administer expired vaccine to 450 patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information received included reported details added.
hot arm, swollen, black and blue mark, rash starting at underarm to injection site, red, hard ball at site
Dizziness, cotton mouth, drowsiness. Unable to stay awake, hard to move mouth, facial muscles, tingling in face. Headache could feel inject contents move up and through arm in a rush about 5 min after given. Next day-headache, still dizziness with fast motion. Hard to focus attention.
This spontaneous report as received from a consumer refers to herself, a 61 years old female patient. The patient was vaccinated "under the skin" with ZOSTAVAX (lot number not specified) on 22-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient had surgery. No further information regarding surgery was reported. Two days later, on 10-OCT-2012, the glands behind her right ear swelled. The next day the glands went back down to normal. No treatment information was reported. The patient sought medical attention. She told her doctor that she had had the vaccine and the primary reason for calling was to determine "if the antibiotics destroyed the vaccine". The reporter did not provide a causality assessment. Additional information has been requested.
sick.; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that it does make some sick. Can be the preservative or the person can be allergic to an ingredient or the person immune system could fight the vaccine. Happened to patient twice and patient had no reason to be concerned because no other vaccine does that.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
pt did NOT have any type of adverse event.  After giving the vaccine, it was realized that vaccine was only approved for 12 years and older.  pt received a full dose of the spikevax (0.5ml) instead of 0.25ml, which is the recommended dose.