chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Right sided supraclavicular lymphadenopathy ~ 1 cm hard, tender mobile and R sided axillary lymphadenopathy tender mobile ~ 1 cm and warmth above injection site (no induration or erythema) 6 days post injection and they are still present day 15 post vaccine
DID NOT TAKE FOURTH DOSE; This spontaneous case (PVX2019-1206) was received from a caregiver on 14-May-2019. It describes a female consumer who "did not take fourth dose", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took only three doses of Vivotif, a month ago. She did not take the fourth dose till now.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take fourth dose" was considered as not applicable.
pt did not learn to say by-by, dada & mama until age 4;neurologist dx pt as having expressive language delay;pt has been in speech school training since age 3;show signs of autism;
Pt completed 3 doses of series of Engerix-B & showed no dectable titer; titer done 5 wks p/3rd dose;
A few hours after my booster shot, my heart started to have a tight feeling. It increasingly started to feel tight and heavy and I started to feel like it was slightly harder to breathe. A few more hours later, these feelings intensified slightly more and in addition my heart felt like it was beating faster. My bones and joints began to feel sore and hurt along with a slight fever but these feelings went away about an hour later. Although the tight and heavy feeling along with the more rapid beating in my heart felt less intense the next day, these feelings remained and I still currently feel all of this at this point in time.
Erythema, warmth, itch. 11cm wide x 22cm long. Tx Hydrocortisone 1% cream top tid. Allegra 180 mg daily for itching.
Redness and hardness at injection site day after injection. Also arm was very sore and I could not lift it above a 90 degree angle for 36 hours after shot or was in a lot of pain. Redness and hardness increased into a lump and then the itchiness started 36 hrs after injection. Over a week later pain is gone but redness and hardness and itchiness is still happening.
Mother of infant noticed a Varicella-like rash about 2 days after the administration of the Varicella vaccine on abdomen, arms, hands, legs, face, and groin area.  There were no reports of fever or any other type reaction.  Parent was advised to administer age/weight appropriate dose of Tylenol to infant for any pain/fussiness associated with rash.  And parent v/u.  Was told to call MD with any further questions or concerns.
Information has been received from a nurse concerning a 15 year old female with no past history of seizures and no history of drug reactions or allergies who on approximately 07-JUL-2008 was vaccinated with the first dose of GARDASIL. Right after the vaccination the patient experienced convulsions. The patient "improved" the same day. subsequently, the patient recovered from convulsion. The patient sought unspecified medical attention. Upon internal review, convulsion was considered to be an other important medical event. Additional information has been requested.
After administration of influenza vaccine, patient felt queasy and lightheaded. Participant, was taken to ER by ambulance.
Patient arrived with 10cm diameter red area on upper bicep. Complained of area being tender, red, and hot to the touch. Pt reported the area itched slightly prior to turning hot and red.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. In August 2014, the patients were vaccinated with RECOMBIVAX HB (lot # J007943, expiration date 05-FEB-2016; route and dosage not reported). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
***I am reporting a Covid-19 vaccination.  Patient had received a Moderna Vaccine on 4/3/21.  She requested Pfizer brand for her second dose and stated that she didn't want the Moderna due to blood clot issues.
This spontaneous report as received from a pharmacist refers unspecified number of patients of unknown age and gender who on 24-NOV-2015 were vaccinated with improperly stored PROQUAD (Merck) lot # L032759, Expiry date: 24-FEB-2017, Lot # L033698, Expiry date: 28-FEB-2017. No adverse events were reported. This case is one of the two reports received from the same reporter. Additional information has been requested.
huge floaters in my right eye; it disrupted my ability to work at my job; This is a spontaneous report from a contactable consumer(patient). A 60-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 30145BA) via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:45 (Age at vaccination 60-years-old) as dose 1, single for covid-19 immunisation. Medical history includes Right shoulder injury and chronic work stress, ADHD primarily Inattentive type from unknown date to unknown if ongoing and Known allergies Penicillin, shrimp, lobster, codeine in Aspirin. Concomitant medication includes bupropion hcl (BUPROPION HCL) taken for an unspecified indication with in 2 weeks of vaccination. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 13Oct2021 at 11:00 am, patient stated that I got huge floaters in my right eye, and it disrupted my ability to work at my job. I had to go to the optometrist to get my eyes examined. Adverse event results in physician office visit. Events leads to Disability. Treatment received for the adverse event with eye exam and need for new glasses. Patient has not diagnosed with COVID-19 prior to vaccination and tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test and result was negative on 28Oct2021 Nasal Swab. Outcome of the was not recovered.  Follow-up attempts completed. No further information expected.
At 2 months of age 105 fever 30hrs after immunization unconsolible for 1 hour.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old patient of unknown age who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (batch number: UT6259OA) (expiry date:30-Jun-2019) (dose in series and route were not reported) rather than 0.5 ml in the left quad on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant mediation was not reported. It was a case of actual medication error case Vaccine underdose. It was not reported that if any adverse event was not reported. 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 sender: none.
expired dose of Engerix B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 4G2TT, expiry date 20th February 2021) for prophylaxis.   On 5th May 2021, the patient received the 1st dose of Engerix B. On 5th May 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Nurse reported that the patient received a dose of Engerix B vaccine which was already expired on 20th February 2021. All patient identifiers were reported as well as batch number and expiration date. The reporter consented to follow up.
blood splotches/ some splotches of what looked like blood on the towel; This is a spontaneous report from a contactable consumer reporting for himself. A 71-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via intramuscular route on an unspecified date, at 71 years of age, (Batch/Lot number was not reported) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included acetaminophen twice a day, one in the morning and one in the evening, taken for an unspecified indication, since an unknown date. The patient reported that the nurse put the little Band-Aid where she gave the shot. About 2 hours (or maybe a little more) after his second dose, he came home and took a hot shower and the band-aid fell off and when he was drying himself he noticed some blood splotches/some splotches of what looked like blood on the towel and he didn't see any bleeding from that spot. He thinks it was from the spot where the injection was given. It didn't continue to bleed. The event was assessed as non-serious. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
about 11 days after vaccine as given patient developed urticarial like lesion around injection site with scattered papules on torso and face.  improved with diphenhydramine.
I received the vaccine Friday, 8/31/07 at about 9:30 AM.  There was minor soreness, but it felt as if it was in the bone rather than muscle.  On Saturday morning, I woke up with a headache, but took my usual Fosomax dose.  I began to feel nauseous. (I have had no nausea from Fosomax in the past.)  I vomited the water and pill, and vomited two or three times more over the course of an hour or two, spent sitting in a chair resting.  By 11 or 12 o'clock I was able to be up and around, and ate normally later in the day, though I still felt tired.  A bursitis-like pain has developed in my left arm (the injected arm). I have treated it with OTC pain meds, and it is gradually resolving.  I have not had a similar pain before.
Hush was bib mother this afternoon for inconsolable crying and grimacing since awakening after vaccinations. Began 2 hours ago. Grimacing has been every 30 seconds. No syncope, fever, vomiting, but will not nurse. Per literature, I think this is myoclonic reaction to Dtap, vs cramping pain from ROTATEQ. Soft abdomen. She did vomit with attempt at APAP for possible pain reaction. With this in mind, will allow home d/c, close observation and return to ED with any signs of emesis, hard stomach, cyanosis, prolonged clenching, or nursing refusal tonight. I suspect that this will abate over 24 hours. Mom and dad agree to this immediate POC.
Breakthrough case admission after 2 vaccines  Moderna 3/30/21 Lot# 025B21A;  Moderna 4/27/21 Lot# 048B21A
Headache, Myalgia, HEADACHE, FEVER, CHILLS, NAUSEA, BODY ACHES Narrative:
I ended up having a delayed allergic reaction to the second dose of the vaccine, which was also split in half based off of my reaction to the first vaccine. The reaction was hives (located on the inside of my knees). I also had some leg discomfort. This was not pain- but it was more of a heavy feeling or like the feeling of when a limb is asleep. To treat the hives I took benedryal and the following day claratin.
My legs became very weak (almost paralyzed). I couldn't hold myself up and ended up sitting on the floor (unable to get myself up). I got some help getting up. Although I am much better now, I still feel a little weak in the knees.
Approximately 10 minutes after receiving 2nd dose of  Covid-19 Moderna vaccine, patient  began to have difficulty breathing. Husband reported that she has a history of panic attacks. No swelling in throat was noted. Instructed patient to  take slow deep breaths. 911 was called. Vitals obtained with blood pressure 118/80, respirations 30-35 per minute, SP02 at 97% on room air.  Patient was transported via ambulance to Hospital.  Spoke with the ER and she reports that patient is doing fine,  they diagnosed as anxiety and gave her Ativan . Patient discharged back home.
Arm very painful early in AM.  Became very cold and could not get warm.  Even with several blankets and heating pad.  Husband said I was very flushed.  Took ibuprofen and went to bed.  Next day became very weak and sweaty when trying to get dressed.
Symptoms reported have She states that she felt horrific; Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunodeficiency.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific). At the time of the report, IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided. The patient took previous Moderna vaccines and had severe side effects with each one for 36 hours. The patient felt horrific.   This case was linked to US-MODERNATX, INC.-MOD-2023-748880 (Patient Link).   Reporter did not allow further contact
On October 18, 2022 at approximately 0550 sudden onset of tinnitus in the right ear that worsened over 2 hours to the point of hearing loss.  Seen at the Drs by 1030 same day and had ear flushed with no resolution.  Referred to ENT Dr. who flushed right ear without resolution.  Had hearing test and diagnosed with sudden onset hearing loss (80% loss).  Initiated treatment of steroids for 2 weeks.  Treatment is currently underway.
rash began approx 8 hrs p/MMR; on upper body only, itched; reports did not make welps, not raised rash at all-red under skin; exp panicky feeling; took DPH, itching subsided; rash for 24 hrs;
pt recvd vax; mom called 28oct94, had fever of 105.7 last eve;states always spliced hi fever p/ each shot;legs shakey; does not want to nurse;advised to take to PMD; fever dec w/ motrin;
Severe arm pain that radiated from site of injection to her elbow and neck. feels like it is tingling
I have Radial Nerve Damage and I cannot move my wrist up , and I do not have mobility of my right hand .
No adverse reactions patient given Hep B 20mcg/1ml was private pay instead of Hep B 10mcg/0.5ml this was state Hep B. Follow-up Information:  11) Adverse event onset there was none
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 4:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.46.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021 The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
local rxn, lt arm, pain, swelling, redness, T > 100 F, pain in joints, severe headache.
fever 100.8 severe pain head ,neck, back, shoulders ,back arms hands hot cold sweats, lungs , weakness
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Medium
2 hours after injection I felt strong pain at the injection site as expected.  10 hours after injection I felt the expected side effects of tiredness, slight headache, sore body, and slight nausea.  I went to bed.  12 hours after injection I woke up in intense pain feeling very sick.  My entire body hurt on a scale of 10 out of 10.  My neck muscles especially were so tight that it was unbearable and beyond a 10 on pain scale.  I had a headache.  I felt very nauseous like I might vomit at any moment.  My breathing became shallow.  I had chills to the point that my teeth were chattering and I was shivering uncontrollably even though it was 76 degrees inside my home.  I considered calling an ambulance, but was hoping this would pass.  There we moments I felt I might die and I left my door unlocked so EMTs could get in as I was still on the verge of calling for help.  I was unable to sleep due to the intensity of pain.  I could not eat and drank very little.  Day 2 I was still in intense pain on a scale of 10 out of 10.  I had a fever for a short time on and off.  I did not eat for two days.  I was able to take naps for one hour at a time, but then would wake up to a crushing headache and intense neck pain.  The second night I was able to sleep, although I woke up in the middle of the night drenched in sweat.  I would go from being extremely cold to sweating heavily feeling hot.  I eventually became very hungry but was afraid to eat and was still nauseous.  On day 3, the pain scale of my symptoms went down from 10 to 6.  I felt much better.  I was able to eat and drink well.  Day 4 I was not in pain but was exhausted and depleted.  Day 5 I felt I was recovered.  Please note:  I normally have a high pain threshold and I run up mountains and am used to pain.  I also have always had flu shots with no bad symptoms.  I am pro-vaccine.  But something went horribly wrong with this 2nd Moderna vaccine shot.
Sept 26/21 - 2 days after first shot I had a shooting pain up my nerve on my left leg. the pain persisted for a couple of weeks so called my doctor got an appoint with my GP Oct. 18/21 was the soonest I was able to get in.  My doctor made me feel comfortable in saying she didn't think it was a blood clot and it it persisted to see her again.  The pain did persist, and I was scared to went to emergency on Oct. 20/21.  They did blood work and told me if pain persisted after a week to come back to Emergency.  The shooting pain up my leg persisted even after my second shot so went back to Emergency on Nov. 6, 21 I ended up getting the same doctor I had on Oct. 20/21 at Emergency she thought it would be best to have an ultra sound so was able to one on Nov 7/21.  I was flying to Mexico and wanted to be cleared of a potential blood clot in my leg.  I was worried and scared.  Nov 25/21 - Went to see Dr re nerve issues/vaccine related - pain still peristed  Was in another country Nov. 29-Dec 7 2021  Somewhere between Sept. 26 to Dec 5 the Nerve Pain turned into involuntary muscle twitches throughout my body that doesn't stop 24/7. I have video footage as early as Dec 5/21 of the muscle twitches. The twitching is all through my body in random places but mainly the leg's.  It doesn't stop, it hard to sleep, stay sleeping, I also have nerve fatigue along with this. This hasn't stopped for 8 months now and continues.
FEELING TIRED, SORE AT INJECTION SITE, REDNESS TO INJECTION SITE, FEELS HEART RACING.
Incontrollable diarrhea and it happened at night, had to use incontinence supplies. Could not leave the house because of embarrassment. Was issued Budesonide for treatment 3 tablets once daily since April. Issue has been helped but has not recovered.
Fever reaching 102 the night of 3/20. On 3/21 my fever stayed at 100.4 after taking advil. Severe body aches, chills, skin pain, and severe headache.
Information has been received from a physician referring to patients of unknown age and gender. Concurrent or historical condition was not provided. On an unknown date the unspecified number of unspecified patients were administered improperly stored dose of ROTATEQ (lot # L008054 with expired date of 30-NOV-2016, strength, dose and frequency unknown) orally. Concomitant therapy was not provided. The vaccine was stored under 33.4F for 41 minutes. Previous temperature excursion included 73F for 1 hour 29 minutes, 34.1F for 2 hours 3 minutes and 34.3F for 1 hour 29 minutes. Data logger was involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.