chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported at 0953 lightheaded, anxious.  @ 0954 160/110, HR 95, OxSat. 100%, Blood Sugar 99.  @1004 BP 142/108 HR 93, OxSat 95%.
Patient returned to pharmacy with a rash.  Administered liquid diphenhydramine 25mg and watched patient.  After 10 minutes, patient reported dizziness and passed out.  Upon that time, Epi-pen was administered into the left leg and EMT's were notified.
Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (Lot Number: EL9261) at 9:00 am on 22Jan2021 (at 84-year-old) in arm right at single dose for COVID-19 immunization. Other medical history was reported as high blood pressure (HBP), high cholesterol, thyroid cancer removed in 2003 (thyroid cancer from an unspecified date to 2013), breast cancer from 2009, hemorrhoid surgery in 2011, polymyalgia rheumatica (2018 & 2020), hip injections in 2018 & 2020, and cataracts removed both eyes in 2018 (cataracts from an unspecified date to 2018). The patient had allergy to morphine. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID), metoprolol, triamterene, montelukast, and atorvastatin calcium (ATOR), all taken for an unspecified indication, start and stop date were not reported. There's no other vaccine in four weeks. The patient experienced pulmonary embolism at 02:00 am on 01Feb2021. The event resulted in emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event). The event treatment included apixaban (ELIQUIS). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9809) via an unspecified route of administration at 9:00 am on 12Feb2021 in arm right at single dose for COVID-19 immunization. No COVID prior vaccination, and no COVID tested post vaccination. The outcome of the event was unknown.
This is a 58-year-old female with PMH of HTN presents to the ED s/p fall PTA. Patient reports that she found out her daughter was positive for COVID-19. Patient was going out to get tested today she slipped and fell on ice. Patient reports hitting her head back and ribs during the incident. Patient denies any LOC, focal weakness dizziness lightheadedness. In the ED, patient was tested positive for COVID-19. CT shows fractures involving the left transverse process of L1 and L2. There is a minimally displaced fracture of the left posterolateral 11th and questionable fracture of the posterior lateral 10th ribs. Patient was administered 2 mg morphine x3 doses to control the pain. Patient was recommended to keep in observation for pain control overnight. Neurosurgery was consulted in the ED who recommends no treatment indicated at this time. Upon evaluation in the ED, pain is aggravated with minimal movement. Patient denies any chest pain, shortness of breath, difficulty breathing, dizziness, lightheadedness, visual changes, neck pain, nausea vomiting diarrhea fever and chills
Patient stated having myoclonic jerks on 3/28/05.  After her 4 month vaccinations, she had uncontrolable seizures that resulted in hospitalization for about six months.  She has had numerous testing done at Hospital and results have remained, no known cause.  4/30/2008 MR received for >10 admissions from 3/29/2005 to 3/09/2008.  Initially admitted 3/29/2005 in status epilepticus, progressive in nature since 2pm. Episode started with arm and leg twitching, which progressed to myoclonic jerking of upper and lower extremities with LOC.  Admitted multiple times subsequent to this even with DX: Myoclonus for DOS 4/10-22/05.  Pt developed refractory seizures of multiple types including generalized tonic-clonic seizures, complex partial seizures as well as myoclonic jerks, eye deviations. Frequent admissions for increased seizures as well as various infections (Candida, Mycobacterium, C.diff). Developmental delay noted by 5/2005 with regression. Hypertrophic cardiomyopathy dxd 6/2005. Suspect metabolic or mitochondrial disorder. G-tube placed after failed swallow study. Ketogenic diet started 2007 with good control of seizure. Poor muscle tone and head control. Assessment 3/11/08 Status epilepticus, Global Developmental Delay, Possible mitochondrial disorder.  4/17/09 F/u received reporting pt's death in December 2008. 5/14/09 Genetics note recd dated 11/20/08 for eval of genetic testing done. W/U  (-) for known disorders.  Most likely a mitochondrial d/o, unproven.  6/24/09 Verbal report from ME's office with COD -hypoxic ischemic encephalopathy complicating probable viral myocarditis in a child with developmental disorder of uncertain etiology. manner of death natural. 8/3/09 Autopsy report received with above COD.  Final Dx:  Lymphocytic Myocarditis with hypoxic/ischemic encephalopathy.  Chronic Bronchopneumonia. Blunt impact injury of the torso-contusion of back. Follow-up: seizures, developmental delay - severe.
Return of monthly, regular and heavy menstrual cycle after entering peri-menopause. 2019: 8 cycles; sporadically missing single months. 2020: 7 cycles; sporadically missing single months & one 3-mo lapse in cycle (Sep-Nov). 2021: No cycle (3-mo lapse) and then cycle starts 8 days post Pfizer COVID-19 injection 1. Now I am getting heaving menstrual cycles on a monthly basis again, like when I was in my 20s and 30s.
Onset of redness/pain/swelling into (R) UE one week after shot. Symptoms progressed into the next day. Seen at PCP office and diagnosed with cellulitis. Given script for 1 week of Cephalaxin. Also taking Ibuprofen. Redness has decreased but swelling and itchiness have continued with joint pain (R) shoulder and (R) elbow.
Pt recvd HIB/OPV on 7MAY92 & was hospitalized w/high fever; dx HIB meningitis; CSF culture pos for H. Influenza type B; hospitalized 12 days; tx IV Rocephin & Steroids; ? hearing loss; neuro appears good;
My daughter started feeling weak and having left side/stomach pain in the weeks following the shot.  She fainted for the first time three weeks later and fainted again the following week. A trip to the ER discovered a heart condition (WPW) that we were unaware of. She was having heart rate irregularities, but the cardiologist said they were not typical of WPW. The WPW was fixed on July 17. But her condition only got worse. She has extreme dizziness, fatigue and experiencing migraines for the first time in her life. She has missed tons of school. She was a ballerina and can't dance or do anything anymore. This vaccine has ruined her life.
Patients states that 2 days after getting the vaccine that she is experiencing pain right above her right ankle. Patient says she feels this pain every time she walks and believes it is tendon pain
Varicella - Information has been received from a nurse practitioner concerning a 12 month old Caucasian male patient with an upper respiratory infection (afebrile) and benign macrocephaly who on 03 Apr 2000 was vaccinated with a first dose of varricella virus vaccine live sc in the left leg.  Concomitant vaccination that same day included a first dose of mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) MSD sc in the right leg.  Concomitant medications included chlorpheniramine tannate (+) phenylephrine tannate (+) pyrilamine tannate rynatan.  On 12 Apr 2000 the patient developed a mild case of varicella with less than 50 lesions and on the following day he was seen by a physician.  Follow up information from a nurse practitioner indicated that the patient was seen on 27 Apr 2000 and 12 May 2000 and the lesion had resolved.  Subsequently, the patient recovered.
Pt is a female teacher who received FluMist through our school-based influenza vaccination program on October 2, 2008. Within an hour of receiving FluMist, pt complained that her tongue was getting numb and swollen, and she was becoming itchy and splotchy. She was treated at the school with Benadryl 25 mg by mouth but refused additional Benadryl or Epipen. EMS arrived at the school and administered intravenously 25 mg of Benadryl. She was subsequently taken to emergency department and by the time she arrived she was feeling better. She never experienced hypotension, wheezes, stridor, or respiratory distress. Pt was not hospitalized and discharged home on Benadryl 25 mg by mouth every 6 hours until midnight.   Past Medical History: Nasal allergies Medication: Wellbutrin SR, Allegra D, Nasacort spray and birth control pill.   Influenza vaccine: FluMist Date of Vaccination: 02 Oct 2008 Date of Birth: 02 Aug 1974 Date of SAE: 02 Oct 2008 SAE:   Event was related to FluMist and serious
Vaccine given at work left arm on Friday 1:45 pm and felt like tight Blood Pressure cuff  on my arm within 30 mins. This was constant pressure that lasted until I slept that night.  went home after work, ate dinner, then sleep with my CPAP. Slept late, woke up 1:40pm with entire left arm numb, but still able to move it. (sleeping on right side) and numb tongue that felt swollen. Stroke?  I got up and as time progressed over next 30 mins or so, I started coughing more, felt like sore throat, itchy, having trouble clearing my throat, some trouble breathing, tongue didn't look swollen, but it felt like scotch tape underneath my tongue with someone slowly pulling tape off. with top of tongue swollen and heavy.  2:25pm I took 25 mg Benadryl oral tablet and called 24/7 RN hotline and was told to go to ER and take another 25 mg Benadryl tablet which I did. I arrived at ER and was really coughing hacking repeatedly. Short of breath, kept trying to clear my throat. Seen in triage. No meds given, this was? <20 from time I took Benadryl.  About an hour later I did have about 15 mins of feeling like I was wearing a very snug neck turtleneck with 2 brief cool sensations going down the middle of my throat and down both sides of my upper chest.   I felt better when I kept my neck very straight versus looking down.  I was later seen again and felt 75% better, given Dexamethasone and Pepcid.  Discharged home. around 6:30pm.  Took Benadryl 50 mg again 10 pm same night.
rash showed up; hives; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 12Mar2021 11:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes II. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 20Feb021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 15Mar2021, the patient experienced hives. On an unspecified date, rash showed up in the evening. Caller would like to know how many days after the covid vaccine could side effects show up. Caller reported having no reaction on the 1st dose of the covid vaccine. However, 3 days after she received the 2nd dose, she broke out in hives. She saw her doctor, and she currently took over the counter stuff. She was told that if no improvement she should go back to see the doctor tomorrow. On monday evening the caller broke out in hives all over her body. Could it take that long for this to show up. They do not run any tests yesterday when the caller went to her primary care provider. The caller doctor told her to get Claritin and Benadryl to see if it would help. All her family members have had no side effects from their Moderna vaccine. The clinical outcome of events hives was not recovered and rash showed up in the evening was unknown.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a company representative on behalf of a contactable physician. A patient (unknown age and gender) received a dose of PREVNAR 13 and a dose of FLUZONE on an unknown date. Relevant medical history, concomitant medication and past product history was not reported. On an unknown date, the patient experienced high fever and was admitted to the emergency room. The outcome of the event is unknown. No additional information was available at the time of this report.
pt devel rash on lt thigh 6' from site;T103 x 4 days;rash now on forehead looked like heat rash;rash spread to chest;rash not raised but under skin;
This is in follow-up to repor(s) previously submitted on 11/14/2008. Information has been received from a physician concerning an 18 week old female with no pertinent medical history or known drug reactions/ allergies who on 30-JUL-2008 was vaccinated PO with the first dose of ROTATEQ and 30-SEP-2008 at 8:45a.m. was vaccinated PO with the second doses of ROTATEQ  vaccine (lot # for both doses 657671/0902U).  There was no concomitant medication. There was no illness at time of vaccination. The physician reported that two days after the second vaccination, approximately 02-OCT-2008, the patient developed vomiting and significant diarrhea (6-8 stools per day). The patient recovered in two days, approximately 04-OCT-2008.  On approximately 06-OCT-2008 (two days after patient recovered).  The patient relapsed and developed diarrhea and vomiting.  On 08-OCT-2008, a stool sample was obtained and the results were positive for rotavirus.  The patient sought medical attention at an office visit (the course of treatment was not reported).  The patient was reported as recovering.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. A positive fecal rotavirus was found on 09-OCT-2008. On approximately 10-OCT-2008, the patient recovered from diarrhea which lasted about 8 days. On an unspecified date the patient was considered recovered. Additional information is not expected.
Flu vaccine given SQ while Varivax vaccine given IM.  Doctor spoke with the parent, explained situation, told them what to look for (signs and symptoms), and offered to regive vaccines at later date.  Dad declined.
Day of vaccination, in the evening felt like i had been hit and my arm was almost immobile.  If I moved my arm, pain localized in the socket was intense.  I went to bed early because of the pain.  For the next 2 days the pain continued, my arm had to stay close to my body, with little movement.  On the 3rd day could feel the pain lessening.  The fourth day I could move it freely and finally returned to normal.  i didn?t report my problem with the vaccine but today had boil like itchy skin above the shoulder joint.  I took a picture of the skin.   With the eruption of my skin, I thought I should report it.  I?ve never had a vaccine shot that brought pain like this, and then later reaction of a boil-like itch.
Moderna COVID-19 Vaccine EUA On first day of injection an itchy red, hot, hard lump appeared at  the injection site.  This reaction lasted approximately 2 days and disappeared. Exactly one week after the injection, the same area became red, itchy somewhat rash like, warm to the touch and a bit lumpy/raised. This area was a bit larger than previously and  about 2 inches across by 4 inches long at the injection site on arm below the shoulder. The redness resolved slowly after about 48 hours. It remained somewhat itchy for another day.
Pt received the wrong Pfizer vaccination. Pt received the orange top instead of the purple top.
Started on April 2nd, 2021, noticed that his left eye was drooping.  He did a stroke test as he is a EMT, then 20 minutes later  when he went to take a drink of something he noticed his facial droop on the left side.  Saturday he went to the ER and was put on PRednisone, and Valcyclovir.  Had follow up today with a provider and the medication has not improved anything.
Starting feeling ill, achy, arm swollen and red (3x normal size 2-3 inches above and below injection sites.
Full body episodes of paralysis due to exacerbation of congenital periodic paralysis.  Initial time span of daily episodes of full body paralysis began April 6 and ended June 22 with several  ED visits and hospitalizations.  Beginning April 27, a PICC line was placed such that IV dextrose fluids could be administered at home instead of in the hospital.  During this time frame, some days an episode did not take place while other days 2 episodes happened. Between July 30 and August 4, 3 different fully body episodes occurred.
I was given 2 different vaccines - chills, body aches, red swelling in arm
SEVERE CHRONIC NEUTROPENIA; NOT FEELING WELL; SHORTNESS OF BREATH; LEG PARALYSIS AT TIMES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included cancer, chronic obstructive pulmonary disease (copd), and diabetes mellitus (dm). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: 25/MAY/2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 30-MAR-2021, the patient experienced shortness of breath. On 30-MAR-2021, the patient experienced leg paralysis at times. On 30-MAR-2021, the patient experienced not feeling well. On an unspecified date, the patient experienced severe chronic neutropenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, shortness of breath and leg paralysis at times was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid vaccine-leg paralysis at times ,severe chronic neutropenia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Large area of erythema and edema at site of injection, developed within 1/2 hr of receiving injection. Subsequent development of diffuse maculopapular pruritic rash on trunk and extremities.
Vaccine at 9 am. By 1 pm getting mild headache and nausea and fever symptoms including chills. By 6:30 pm, severe headache and nausea. Felt extremely hot and chills at the same time. May have had fever. Slight stomach ache. Would not have been able to work and notified work that may have to stay home next morning if felt the same way. Headache improved after Advil. Took hours to fall asleep and woke up several times throughout night. Woke up with slight but improved chills in the morning and back to mild headache and nausea. Very minor nausea and headache rest of day but back to mild headache and nausea the next day at 8 pm.
Legs and all extremities are all swollen up excessively, tongue swollen, lymph nodes feel swollen, pain behind left eye, no appetite, rash on thighs. The symptoms are continuing as of 2/16/2014.
After first dose: Mild flu like symptoms After second dose: extreme acid reflux, more severe flu like symptoms After booster (3rd dose): hives all over back, near anaphylaxis, extreme swollen face, eyes closed up,  ears felt full, lasted for 2 or 3 weeks then loud tinnitus in left ear only ever since
Extreme nausea & headache, Unable to eat or drink without vomiting for two days, Given IV fluids (sodium chloride o.9% (2 bags), Ondansetron (Zofran) , Ketorolac (Toradol) on 10/29/2021 starting at 6:07 pm
Pneumonia shot temperature of 102 for 24 hours. Site of injection was swollen from shoulder to wrist one inch around entire arm-very painful-lasted four days.
Severe ringing in the ears. It started a couple of days after I got the vaccine. It's been a week and I'm scheduled to get my second shot on April 27th. If it persists I'll see the doctor.
Around 6 pm  last night he had 100.3 fever and it went up to 100.7 by 3 am.  He had a lot of  fatigue and his balance was off.  I found him bent over a chair in the bedroom @ 3 am and he couldn't straighten himself out. He needed help to go to the bathroom. He was very off balance. He hit his head into a cabinet that is above the toilet. I had to hold him  up as he used the toilet. He also had a problem getting back into the bed twice.
This initial spontaneous report was received from a physician referring to a 4 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 14:32 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
a baseball size lymphadenopathy/ left axilla swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EK9231, Expiration Date: 30Apr2021) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: covid-19 vaccine (Covid-19 Vaccine , First dose: , Date: 22Dec2020, Lot: EL0140, Exp: 31Mar2021), administration date: 22Dec2020, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "a baseball size lymphadenopathy/ left axilla swollen lymph node".  Additional information: She previously reported that she experienced at approximately 10 pm the day of her Covid-19 injection that she had a baseball size lymphadenopathy on the same side of the shot. She said that she could call it a left axilla swollen lymph node. It was only after her second dose of the Covid-19 vaccine.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse practitioner concerning an approximately 14 year old male patient. There were no drug reactions or allergies. On 12-AUG-2013, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H020901 and 05-JUL-2015 respectively), intramuscularly. There were no concomitant medications. On 13-AUG-2013, the patient developed blurry vision, nausea, vomiting and lightheadedness after receiving his first dose of GARDASIL. On 14-AUG-2013, the patient experienced sprained ankle due to falling in a hole. The patient sought medical attention. The patient was seen by an unspecified optometrist on 15-AUG-2013 (yesterday). The patient was prescribed on unspecified amount of Meclizine due to the lightheadedness. No lab tests were performed. The patient was not recovered from blurry vision, nausea, vomiting and lightheadedness. The outcome of sprained ankle due to falling in a hole was unknown. The relatedness for all the events was unknown for GARDASIL. Additional information has been requested.