chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per doctor's note for 8/20/2021 ED visit: The patient is a 20 year(s) old Male complaining of numbness, arms and legs. Patient complained of waking up at 3am today feeling numb on his arms and legs. He said he has difficulty getting up and walking. He is accompanied by his girlfriend. No slurred speech noted and patient has symmetrical smile. Patient had Guillain Barre Syndrome when he was 9 years old. 20-year-old gentleman with past medical history significant for Guillain-Barré syndrome when he was a 9-year-old child, presents to the emergency department with progressive paresthesias and weakness in his bilateral upper and lower extremities.  He reports his symptoms began yesterday with some mild paresthesias in his bilateral upper extremities.  He then noticed that he was unable to hold his pliers at work.  He thought he may have just overworked his muscles somewhat the last few days so went home and relaxed overnight.  When he awakened early this morning, he noticed that he had some tingling in his bilateral lower extremities and was unable to get out of bed without the assistance of his girlfriend.  He was also unable to dress himself.  Here in the emergency department, he is able to move both his upper and lower extremities against gravity but not for very long.  He is unable to bear weight.  He denies any pain.  He denies any shortness of breath.  Of note, the patient did have an acute gastrointestinal illness last week.  He is fully vaccinated against coronavirus and that series was completed in March of this year.  He denies any difficulty with speech.  He reports that his symptoms do not feel asymmetrical at all.  He also reports that since his childhood bout with Guillain-Barré, he has been told he has never had the return of his lower extremity deep tendon reflexes.  He did not require intubation as a child.  He has not had any episodes of incontinence.
pt recv vax 23SEP97 & 2 days p/vax pt devel severe leg cramps, numbness in arms & legs lasting 13 to 14hr & muscle aches & pains;pt required a visit to ER & dx w/rhabdomyolysis;tx w/muscle relaxants;
Patient presented with redness at injection site, warmth to touch, and slight swelling. Patient was advised to contact primary care MD to be evaluated for further concern. Believed to be injection site reaction, but patient was prescribed antibiotic short course therapy for the reaction.
Employee had flu vaccine in right deltoid and had muscle soreness and ache and weakness first week - lasting days - today arm is "2" out of 1-10 pain scale. Getting better but never had reaction before.
Pt is a 5 yo girl who received her routine school vaccination one day prior to this office visit.  Mother reporting that patient found to have swelling and pain on the left leg at the site of vaccinations this morning. No fever. No dyspnea.  No swelling or redness on the opposite leg where Hep A and DTaP given. Interestingly Twin Sister developed tha same rash and swellign over the same area where she received the vaccination.  Same vaccinations and lot number as in this patient. Per follow-up: Mother reporting that the patient did not have any problems with vaccinations immediately after administration. Patient had fever but no dyspnea or chest pain. Site of injection is tender to palpation.
Headache, chills, fatigue, and fever. Still having headache and fatigue days later after the 2nd dose. I went to ER at local hospital on 2/8/2021 and waited 4 hours and did not get seen. I went to urgent care on 2/9/2021 and was seen by a physician, and was told that they could not do anything.  Headache still severe and hurting off and on,  I am taking Tylenol and Aleve medicine for pain.
Numbness in face, lips and tongue, all over body rash and hives, high fever
Patient reported of swollen, red shoulder after receiving what appears to be an IM injection 2 days ago.  Joint pain in shoulder.  Patient states it feels as if his shoulder has been pulled out of socket.
woke up, back discomfort following mechanical back strain the week before. Felt nauseated & lightheaded. Sat down in chair. Brief syncopal event resulting in lacerations to lip & chin. seen in ED
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the Department of health and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the Department of health given the increase in dose administered.
Patient stated that she developed hives during the night after receiving the vaccine.  No breathing problems, no other stated symptoms.
No adverse event. Patient was given Dose #2 of Moderna off-label  before the 18th birthday after the 1st was inadvertently given underage.
Soreness in [her] arm, it hurt; [her] arm swelled at the injection site; earaches in both ears, which radiated to her head on both sides; Headaches; Backaches; Chills; Feeling tired; she cannot say whether she had a fever; swollen lymph node with the size of a golf ball underneath her arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06May2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (unspecified if ongoing); "Breast cancer", start date: 14Apr2021 (unspecified if ongoing), notes: same cancer receptors from her breast cancer in 2017 were activated. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06May2021, outcome "recovered" (15May2021), described as "Soreness in [her] arm, it hurt"; VACCINATION SITE SWELLING (non-serious) with onset 06May2021, outcome "recovered" (15May2021), described as "[her] arm swelled at the injection site"; EAR PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "earaches in both ears, which radiated to her head on both sides"; HEADACHE (non-serious) with onset 06May2021, outcome "unknown", described as "Headaches"; BACK PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "Backaches"; CHILLS (non-serious) with onset 06May2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 06May2021, outcome "unknown", described as "Feeling tired"; PYREXIA (non-serious) with onset 06May2021, outcome "unknown", described as "she cannot say whether she had a fever"; LYMPHADENOPATHY (non-serious) with onset 06May2021, outcome "unknown", described as "swollen lymph node with the size of a golf ball underneath her arm". Additional information: Patient has a PET scan on Tuesday, a "bio-auto" MRI with contrast on Wednesday and the second dose of the Pfizer-BioNTech COVID-19 vaccine scheduled on Thursday. Patient asked if there is a potential interaction and/or if side effect that may be expected from getting the vaccine when having "remaining dye" in her "body". On 06May2021, patient experienced adverse reactions 2 hours after vaccination. Patient explained the vaccination provider "jammed" the vaccine into her arm and "hit [her] really hard" Patient explained she cannot say whether she had a fever. She mentioned she failed to connect her reaction to the vaccine until she was told at work that it may be due to the vaccine. Patient explained the same cancer receptors from her breast cancer in 2017 were activated and she was diagnosed with cancer 14Apr2021. Patient asked if the second dose of the Pfizer-BIoNTech COVID-19 vaccine could be administered beyond the recommended interval.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient right leg became very swollen from knee down and was very painful to walk. Patient went to Urgent Care and was told that he would need to have ultrasound done to see what was going on. Patient went to Imaging and was told that he had several blood clots through out his right leg. They advised him to go to emergency room evaluation. Patient went to Medical Center and it was confirmed that patient had blood clots and was put on Xarelto for treatment.
Mother brought baby after 24 hrs of administration of vaccine. The right thigh appears to be swollen and warm to touch and blanching. He was afebrile at the time ice pack applied. Rechecked after 24 hrs. issue resolved.
I noticed swelling and redness on the site of the vaccine on Monday, January 19th. Exactly a week after vaccine administration. Today, Tuesday. Janaury 20th the swelling was larger and it included itchiness and overall weakness on my arm. I decided to go to the urgent care since my primary care doctor had no availability until February.   The doctor that examined me did not have a clear diagnosis. He prescribed Prednisone 20MG tablet, Augmentin 875 Mg-125 Mg Tablet and over the counter antihistamine.
COVID-19 positive January 5th, 2022. Mild symptoms, similar to mild flu symptoms. Stuffy and runny nose, sore throat, headache, body pain.
Patient was dizzy, felt like fainting. However, she remained conscious & was talking. She felt OK after 10 minutes.
Developed fever to 103.  Painful swelling of arm.  The vaccine was given in H.A., arthralgias, nausea.  No rash no oropharyngeal swelling.  No dyspnea.
serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent; acute kidney injury; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration in right arm on 14Mar2021 at 12:00 (at the age of 58-year-old) as Dose 1,Single and received  (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 04Apr2021 at 12:00 as Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient previously took levaquin and ACE inhibitors and experienced known drug allergy. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication on left arm from Mar2021 to an unspecified stop date; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on right arm from Mar2021 to an unspecified stop date. The patient experienced serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent and acute kidney injury in Jul2021 (disability). The patient underwent lab tests which included blood creatinine: serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent in Jul2021. Therapeutic measures were taken as a result of serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent and acute kidney injury. Outcome of the events not recovered.   No follow-up attempts possible. No further information expected.
Pt recv vax on 11/9/98; on 12/1/98 pt exp thrombocytopenia w/ petechia rash; tx=transfusion & steroids
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-07-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
High fever with febrile seizures 9 days after MMR. Walked in on a blue baby on day 10.
Hospitalized on 10/20/21. Specimen collection on 10/1/21 and 10/20/21.
TB; severe bronchitis; coughing up blood; severe asthma; flu-like symptoms; made me so sick/ ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: I have a pre-cancer diagnosis; "second hand smoke" (unspecified if ongoing), notes: second hand smoke by illegal aiens after a brief hotel state; "severe asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for asthma, immunisation. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: TUBERCULOSIS (medically significant), outcome "unknown", described as "TB"; BRONCHITIS (non-serious), outcome "unknown", described as "severe bronchitis"; HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughing up blood"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious), outcome "unknown", described as "made me so sick/ ill". The patient underwent the following laboratory tests and procedures: diagnosed with severe bronchitis: severe bronchitis, notes: diagnosed with severe bronchitis; variable, notes: Test results variable.  Clinical course: The patient had a pre-cancer diagnosis, mitral valve prolapse, recent TB exposure due to the County malfeasance - second hand smoke by illegal aiens after a brief hotel state, which a county nurse later reached out to guests to advise of TB exposure - and severe asthma  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse referring to a patient of unknown age and gender. On 15-JUN-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Maculopapular rash started 3 days after the vaccine, not itchy, still presented 8 days after the vaccine (day of clinic visit). Fever 100.5 and headache for 3 days, started 3 days after the vaccine, relieved with Tylenol. Facial swelling with no itching or other anaphylaxis or allegy symptoms, for 1 day, 6 days after the vaccine, relieved with benadryl and allergra, resolved.
Information has been received from a nurse in a physician's office concerning a 20 year old female with a history of fainting episodes and an unknown history of allergies and adverse drug reactions. On approximately 12-APR-2005, "two weeks ago", the pt was vaccinated with her first dose of hepatitis A vaccine. After vaccination, the pt experienced an "episode of fainting" and her "blood pressure decreased precipitously" (blood pressure parameters not provided). It was reported that the pt's blood pressure had been normal just minutes prior to the vaccination. The pt was administered epinephrine and recovered. It was reported that the pt sought unspecified medical attention. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
12 hours after injection developed adhesive capsulitis in the shoulder of the same arm. Adhesive capsulities remains and is currently being treated. 14 hours after injection developed low grade fever which went away after a few hours.
between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight
Not sure what selection to choose from - notes on records indicates "Influenza Quad, 6 Mo - 64 Years was administered on 11/30/2020.  Adverse events - sore arm after the shot with limited range of motion. As times goes by, pain has worsened and left side feels partially disabled; unable to get dressed and undressed on my own; difficulty staying asleep due to pain; unable to perform daily chores without pain.   Treatments - x-ray and MRI. I was referred to see an orthopedics doctor, Dr. He has administered two cortisone shots so far - first time I was told I had bursitis and cortisone shot he administered did not help. 2nd time I was told I had frozen shoulder and the administered shot helped less than 50% for approximately 3 weeks. Dr. recommended surgical option - manipulation of arms under anesthesia followed by physical therapy. I am hesitant with this option due to the pain could be worse after anesthesia wears off and each physical therapy session requires co-pay and there is not a timeline as in how many sessions are required since each individual is different. Nurse Practitioner at my primary care doctor's office (Dr.)  said she suspected the nurse who administered the shot either went in too high or too deep. However, Dr. said he believed the shot was only an coincidence; the shot probably just triggered an inflammatory response. I have since requested a referral to see a neurologist to see if there is any nerve damage and I am waiting for a response from Dr.'s office as of now.
On day 9 after the vaccine, my daughter experienced extreme naseau, vomiting and an illness that we first thought must have been food poisoning. Over time, the symptoms wer diagnosed to be gastroparesis and damage to her vagus nerve. She continues to suffer from flair ups and her life has been greatly comprised due to her inability to eat and digest food normally as she did before her shot.
pt very cranky for 24 hrs; t102 ax; crying w/o consolation until next AM; pt conts to be sleepy & constipation;
Rash & UrticariaPruritus Narrative:  DEVELOPED RED ITCH RASH AT INJECTION SITE DAY 8 AFTER VACCINE AND JUST DISAPPEARING TODAY JAN 25
PT REACTED TO 1ST DOSE OF COVID VACCINE W SOB AND DIFFICULTY BREATHING.  PT ALSO WENT TO ED FOR TREATMENT WITH 1ST SHOT.  PT SAW AN ALLERGIST WHO PRESCRIBED PREDNISONE BEFORE 2ND DOSE + DIPHENHYDRAMINE, WHICH SHE TOOK BOTH.  PT GOT 2ND DOSE ON 6/2 AND STILL HAD DIFFICULTY BREATHING AND WENT TO THE ED.  PT GOT PREDNISONE 50MG, DIPHENHYDRAMINE 25MG PO, AND PEPCID 20MG.  PT DID OK AND WAS DISCHARGED TO HOME.
Initial misuse report received from a health care professional on 23 October 2013 and the case was received on 21 March 2014 at GPV. A 2-year-old patient (gender was not provided) had subcutaneously received a dose of 0.5 ml of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none
presented to ED with worsening SOB, fatigue and hypoxia (O2 sats 70%); had recent hospitalization after testing positive for COVID 5 days prior to coming to ED; has been on dexamethasone; placed on BiPAP; COVID pneumonitis; DNR/DNI; condition worsened and pt was placed on comfort care and taken off of BiPAP; pt died shortly thereafter in the hospital
Large raised itchy 4" long red patch at injection site; Large raised itchy 4" long red patch at injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6202, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 08Mar2021 10:30 (at the age of 71-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included asthma and allergy to sulfa products, Advair discus, Augmentin, and Premarin cream all from an unknown date. The patient's concomitant medications included unspecified asthma medications. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL9266, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 15Feb2021 10:30  for COVID-19 immunisation. The patient experienced large raised itchy 4" long red patch at injection site on 08Mar2021 17:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19.  The outcome of the event was recovering.   No follow-up attempts are possible. No further information expected.
Receive axine at 6:20 p.m. January 6th 2021 at approximately 11 o'clock p.m. January 06, 2021 began running lowgrade temp Feeling very cold developing chills When Realise I was very sweaty and started developing body aches Took Tylenol extra strength 500 mg for fever and body aches try to drink plenty of fluids symptoms alleviated within the next 48 hours On January 11th 2021 I then realised I developed a localised rash around injection site Red raised and warm to the touch
Patient presented to the ED the morning after receiving his first COVID-19 vaccine with a chief complaint of tongue swelling and difficulty speaking. Patient received his vaccine at approximately 12:00pm and presented to the ED around 08:00am. Isolated tongue swelling and abnormal speech was appreciated on exam. Patient was given famotidine, methylprednisolone, epinephrine, and diphenhydramine in the ED. Patient was then admitted to the medical ICU for monitoring.
During the two days following receiving the second dose of Modera, I had a massive drop in blood pressure which caused extreme dizziness and some faintness when standing up.   My normal blood pressure sits around 123/86 on average and was 130/88 the day of the shot (5/21/21).  The day after the shot (5/22/21) my blood pressure dropped to 102/68 where it stayed for two days before slowly climbing back to normal.
o Reason for Admission COVID with Hypoxic respiratory failure, DKA Pertinent HPI: Sx Onset 2/1 with myalgias, headache, shortness of breath, cough scant mucous, also nausea, retching, diarrhea O2 high 80s on RA, corrected with 3L Covid positive, CXR showing bilateral infiltrates.  Found to be in DKA with AG  24 glucose 628, HCO3<7.  EKG movement artifacts at rate of 100. Given 1.5 liters of fluid, 6 units regular insulin IV then 6 units IV per hour, 2 gm of magnesium and dexamethasone 6 mg in ER. Patient received 1&2 COVID 19 dose but has not received a booster
rapid heart rate; being allergic to monosodium L-glutamate; This spontaneous report was received from a consumer, referring to a female patient of unknown age. The patient's pertinent medical history and concomitant medication were unknown. Drug reaction/allergy included monosodium L-glutamate.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.  The patient reported that zoster vaccine live (ZOSTAVAX) contained the ingredient monosodium L-glutamate that gave her (also reported as them) a rapid heart rate. She also reported being allergic to monosodium L-glutamate. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).