chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ulcerative Colitis about 90 days after second injection; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in left arm on 26Mar2021 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. No Covid prior vaccination. The patient medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (lot number: ER8732) administered in left arm on 05Mar2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient experienced ulcerative colitis about 90 days after second injection in Jun2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included oral and suppository treatment. The outcome of the event was not recovered.
Within 1 minute of vaccine admin, eyes rolled back and had UE & LE shaking/tremors, unable to stop the tremors. This episode lasting approx 30 seconds, and was followed about 3 minutes later with eyes rolling back dusky color thready pulse with rigid contracting of her UES. This 2nd episode lasted about 1 minute total. EMS was activated, transported to hospital.
Pfizer 9/3/21, 9/25/21. Positive on 2/6/22
3 hours after shot, patient was doing yard work. Sudden onset of muscle weakness in arms and legs. Very unusual because she does a lot of work outside and has never happened before. About 10 days later, sharp pain in left leg above ankle. 2 days later, left foot and right foot was numb along with left and right hands. Her thinking was "foggy and different".  Also had minor breast swelling. The breast swelling went away in about 4 to 5 days. Then all symptoms seemed to cycle through body, but not as severe as first time. Took about 30 days to feel completely normal again.
Pt Complained of numbness/tingling around  the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
Baseball size lump with redness and tenderness, hot to touch, redness all over upper arm, weakness, fatigue, elevated temperature. Advice: advil, benadryl.  Took the pt 2 weeks to recover.
fever, chills, body aches x 4 days fatigue and annoying earache x 2 weeks
Left arm swollen from shoulder to wrist - red, hot, painful, lasted for 5 days with itching.  Patient has never had a reaction to any vaccine before.
pt went to bathroom p/receiving vax; while washing hands fainted; mom caught pt & lowered  pt to the floor; pt later awake & shaky; BP 86/40;
Throat was closing, palpitations, shortness of breath, chest tightness, rash cough, wheezing
Approzimately seven hours after a flu shot was given (1:15P to 8:30P)patient started with the chills and unable to get warm, shortly after the patient along with the chills began to shake uncontrollably. Patient an LPN, took her blood pressure and it was in the low 200's, tempurature was 98.2.  We then called our Doctors office who advised we go the local hospital emergency room. Upon arriving at the hospital, patients blood pressure was taken and was 163/93 very high for the patient who usaully is in the low 120's over 60's, no change in temp.  Patient was seen and examined by a doctor who felt it was a adverse reaction to the flu shot, not an allergic reaction. By this time the shakes and chills had begun to calm down.  Doctor had patient relax laying down for an hour after which her blood pressure was taken again and it was normal, shakes had subsided, so was discharged to go home and told she should feel better winthin 24 to 48 hours and if she didn't contact her primary doctor.  She is feeling better this morning, but has headache and feels all washed out.
Coughing about 5 hours after vaccine which over an hour progressed to non-stop coughing with moderate work of breathing. Received steroids, unineb, 2nd hour of albuterol, and was discharged on albuterol puffs and steroids. Improved until resolution 4 days later.
Patient called and stated that she had a DELAYED injection site reaction where the arm area was red and swollen and hard at the site of injection. The size of affected area was about 2" x 1.5" with no itching. The reaction didn't occur until 1 week after the injection.
The patient complained of bruising.  She said the pharmacist required her to rest her arm on the desk. She said the pharmacist's technique was the cause of her bruise.  The shot was administered on the deltoid muscle--the patient pointed to the place where she got the shot.
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose  of Benadryl, 50 mg p.o. prior to coming  to the clinic,  due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
Pt presented on 4/25/19 to Immunization clinic with lesions s/p varicella vaccine that was administered on Tuesday 4/23/19.  Pt stated that she was working where a child who had gone on vacation and parents said that child was dx with chickenpox while gone.  Pt stated she may have been exposed to them prior to receiving the vaccine.  Provider evaluated pt with mild erythematous papules on legs and local reaction to left posterior upper arm about 3x5 cm in diameter presenting as erythema with no induration or warmth.  Prescribed Benadryl to pt and for pt to take ibuprofen at home if she needed it and to not return to work until lesions are cleared.
Patient was given first dose of Moderna vaccine which is not yet approved for patients under 18 years old. Pharmacy checked on Patient, Patient didn't have any side effects from the given vaccine.
Patient broke out with blotches and redness all over his body the day after vaccine. Parent noticed it in the morning time. The pots were very warm to the touch.
A non-serious spontaneous report of dizziness, headache, and nausea has been received from a consumer concerning herself, a 34 year old female, subsequent to FLUMIST. Medical history included hypothyroidism (diagnosed at age 19) and endometriosis (diagnosed at age 18). Concomitant medications included levothyroxine and oral contraceptives, NOS. She has received FLUMIST in previous seasons without experiencing any adverse events. The patient received a single dose of FLUMIST at 12:00 noon on 16-Sep-2009. The same day, at around 2:00 pm, she started to experienced headache, dizziness and nausea. The symptoms continued and on 17-Sep-2009 she took acetaminophen, aspirin, and caffeine, extra strength, 2 tablets, which did not help. The events did not resolve.
Day 1 (5/15/21) 5 minutes after second shot. Overwhelming feeling came over me, felt like I was going to pass out.  Almost like going into shock.  My head fogged up.  These feeling would come every 5 to 10 minutes.  I had to be driven home.    4-6 hours after shot.  Fatigue, foggy brain  14 hours after shot (2:30am).  Woken violently to the same panic feeling earlier in the day.  Couldn't sleep the rest of the night  Day 2 through 7 Tension headach, diaphram spasms, dizzyness, fatigue Night 2 through 7 Severe Insomnia.  Couldn't fall asleep.  Body would try repeatedly, but would get electrical shocks to the diaphram chest area that would immediately wake me back up.  wouldn't fall asleep for a few hours around 4am.  Went to urgent care 5/19.  They ran labs, EKG, blood pressure stress tests and prescribed hydroxyzine.  I never took the medication.  Day 8 through 21 Tension headach, dizzyness Night 8 through 21 Slept pretty well averaging 7-8 hours a night Day 22 6/5/21 Woke with severe anxiety (never felt this before).  Went to urgent care again.  They told me to take hydroxyzine. Night 22 6/5/21 through Present 7/30/21 Chronic Insomnia Day 23 through present Tension Headache and dizzyness  Medications that have helped to sleep but have not cured Trazodone (couldn't take side effects) Alcohol (getting severe rebound anxiety) Ambien (5mg only gets me 4 hours max) Xanax (.375mg only gets me 4 hours max) Clonozepam (.125mg only gets me 4 hours max)  Medication that didn't work Doxepin 3mg/6mg
All of the vaccination not administered. Syringe was cracked/ or not seated below luer lock attachment. When administering vaccination some of the vaccine leaked out onto patients arm.
Patient stated her arm is swollen from the injection. She was advised to take OTC Ibuprofen to help manage the discomfort and swelling.
SEVERE, DIBILITATING HEADACHE - Start about 4-5 hours after the shot I began experiencing a stiff, painful neck - primarily on the right. Within a short time I felt extreme pain in the top of my head - as if an ice pick or meat cleaver were splitting my head open. The pain was so severe I felt almost sick to my stomach. This pain continued with severe pangs to the point of interrupting my sleep.   I saw a MS specialist, on April 1, 9 days after the shot. He said that the headache was related to the vaccine. I didn't seem alarmed even at that point. I had a video appointment with my primary care doctor on April 7 and she also did not seem to think that I should be worried over headaches lasting 2 weeks (at that point.)  As of this morning, I woke up with the stiff, sore neck and a headache - 3 weeks after vaccine.
Patient had been sitting in general observation area post vaccine when she began seizing and fell to the floor from chair. Seizure lasted approx 10-15 sec. Patient came to and was oriented x 3. Assisted patient by EMT x  2 to w/c and taken to private observation area.  1421 BP 174/92; HR 108; O2 97%. Patient hands shaking. Patient states she last had therapeutic drug levels done a month ago and her seizure meds were not adjusted. States she took all of her meds,  but unable to recall all the names. States she left her list at home. States she did not have an aura prior to seizure, but knows she had a seizure. States she feels too hot in there and offered water.  1435 Refuses transport, refuses further treatment. States she has her friend here and her friend will drive her. Called friend and friend bringing car to exit area. Instructed patient to call physician that is managing her seizures to let them know that this occurred. Instructed to go to ED for further eval. Patient states she is going to go  home and agrees to contacting PCP and seeking medical care if seizures persist. Took patient via w/c to awaiting car, assisted to car. Transportation provided in personal vehicle per friend driving.
Narrative:  Patient presented to hospital on 04/08/2021 with complaints of shortness of breath. Patient's respiratory declined in the ED and patient arrested in the ED and passed away. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine.
Four hours after receiving second dose of Moderna vaccine patient reported symptoms of facial numbness on the LEFT side (weakness and tingling), muscle aches, fatigue, mild chills.  Patient seen on 1/25/2021 symptoms resolved at this point. Patient was referred to neurology by the hospital's employee health department after the employee called in the symptoms to the symptom hotline.  Patient did not see neurology.  Patient was tested for COVID at the suggestion of employee health. Patient tested negative.
Information has been received from a Registered Nurse concerning a 12 week old female patient with no pertinent medical history and no known drug allergies, who on 06-JAN-2010 was vaccinated with a dose of ROTATEQ (lot number 664437/0536Y). There was no concomitant medication. On 13-JAN-2010 the patient experienced diarrhea for almost 3 weeks after administration. On 01-FEB-2010, the patient recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from a Registered Nurse who reported that the patient with no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination was vaccinated with the first oral dose of ROTATEQ (lot number 664437/0536Y) on 06-JAN-2010. It was stated that on 07-JAN-2010 (previously reported as 13-JAN-2010) the patient experienced profuse diarrhea for 3 weeks. At the time of the report the patient had recovered. No laboratory diagnostics studies were performed. No further information is available.
Patient came into pharmacy to received PPSV23 (PNEUMOVAX 23), but was administered PCV13 (PREVNAR 13) inadvertently. Patient had already received  PCV13 on 7/13/2016.
Severe itching from the collarbone up; facial itching, swelling; dry, scaly skin; eyelid rash. Doctor prescribed prednisone; said it was hives. I've had hives before. I haven't had any rash like this since a child and then it was on my arms.
sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination treated with tylenol and ibuprofen, suggested warm compress as well
Initial symptoms were normal symptoms: 100.3 temp/fagitue/chills/body aches - this occurred 11 hours after the shot and lasted for about a day.  then 3-4 days after vaccine noticed tender and swollen subclavicular lymph node.  Appointment made with PCP 1/5/2021- followed by bloodwork, ultrasound, andCT scan to rule out cancer and other concerns.  Reactive lymph nodes was the ultimate diagnosis.  At this time was educated to see an ENT if the nodes do not decrease in size.  As of today note resolving of size of lymph nodes - will continue to monitor.
This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered GARDASIL there were stored improperly. No adverse effects reported. This is one of several reports from same source. Additional information has been requested.
chest pain; heavy breathing; dry cough; fever; headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DYSPNOEA (heavy breathing), COUGH (dry cough), PYREXIA (fever) and HEADACHE (headache) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), DYSPNOEA (heavy breathing), COUGH (dry cough), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), DYSPNOEA (heavy breathing), COUGH (dry cough), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Tylenol.
I had a couple nights of fever, was congested. I called my doctor after testing for COVID-19 on March 21, 2023. The doctor prescribed Paxlovid. I started the medication on that Wednesday. I no longer had chills or a fever. I gradually did get better thru the 5-day period. I still have a head cold and a cough.
Received Varicella vaccine on 12/10/21. Started to have localized redness to injection site on 12/20/21. Warm to touch, swelling, itching also present. No loss of sensation or mobility to left arm.  Will make an appointment with MD to follow up with injury.
I had rush in my chest and a taste in my mouth when it was administered then couldnt swallow food 2 hours later could swallow liquid I took benedryl 3 different times throughout the night, next day could swallow food.
Chronic spontaneous urticaria, ie, hives appearing  at 1 or more random locations anywhere on my skin, generally disappearing after a few hours, but appearing in new locations. This also occurred after the initial series (dose 2 on May 21), starting a few weeks after dosing and lasting 2-3 months. It has now begun again after the booster on Dec 3, it's still ongoing and treating with generic benadryl keeps the symptoms at bay.  Additionally, I did have 1 instance of tightness in my chest 3 weeks after the booster, not painful just slightly uncomfortable for just 1-2 minutes. This also happened after dose 2 of the initial series though it happened every few days for about 3 weeks. For this booster though it has only happened once so far.
got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year; got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Reporter (Nurse Practioner) would like to know if they could gave Paxlovid multiple times to a patient in a year. They had a patient who got fully vaccinated with Pfizer Covid Vaccine but got Covid 19 so they gave Paxlovid at the beginning of the year.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 (BNT162B2 NOS to the reported Drug ineffective ,COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300179412 same patient, different drug/AE.;
Not long after going to bed I had chills and I was unable to slow down my breathing. The chills may have lasted a few hours. I don't know how long my respiration was fast.
About 1 hour after dose, I started having severe arrhythmia which lasted over 2 hours. (no pain in my chest). It seemed to be much stronger when I laid down. I was getting ready to go to ER, when as fast as they came on...they went away.  After that, I had discomfort in my chest and slight arrhythmia's for a few weeks.  My 2nd dose of Pfizer didn't cause this but it did give me a temp of 103.8 so am I allergic to Pfizer?    It is important that you know that I was never nervous to get the booster as I believe this is the answer to getting us out of this mess.
Hot, firm red rash on arm discovered 6 inches below injection site. Rash is moving down and across left arm. Rash improves with antihistamines but is continuing to grow.
Fell; Scheduled to get the 2nd on 03/25 (exactly 21 days apart); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FALL (non-serious), outcome "unknown", described as "Fell"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Scheduled to get the 2nd on 03/25 (exactly 21 days apart)". Therapeutic measures were taken as a result of fall.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a medical assistant and refers to a 3-year-old, male patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapies or medical history provided. On 12-OCT-2015 at 10:15, the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068, subcutaneously in the right arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. The patient did not have any illnesses at the time of vaccination. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion that the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1611USA008278: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105.
Information has been received from a physician concerning a 12 year old female patient who on 17-AUG-2009 was vaccinated with a first dose of GARDASIL. Subsequently, that same day, on 17-AUG-2009, the patient experienced a headache that was on the top of her forehead, numbness of the right shoulder and arm, blurry vision in her right eye, and vomited once. The physician reported that the symptoms lasted "a couple of hours", and had not had any symptoms since. Medical attention was sought by calling the physician. Conflicting information has been received from a physician who reported: "No problems - Not sure why I received". Additional information has been requested.
prostate cancer; This is a spontaneous report from a contactable consumer (patient) reported for himself via Pfizer. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunization. Medical history included liver transplant. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient had been recently diagnosed with prostate cancer and taking immunosuppressants, he wanted to know that if it affected the vaccine effectiveness. Treatment received for the event including take immunosuppressants. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx 3 hours after vaccination, patient did describe headache.  About 12 hours after vaccination, patient was describing trouble swallowing and felt like her "throat was closing".  No trouble breathing was noted.  Patient went to local ER and was treated with ketorolac for HA and diphenhydramine.  Patient was back to normal self 15-20 minutes after diphenhydramine.  No further problems reported 12 hours after this.
Extreme Kidney Pain, Tremors or shaking of the body, violent cough, fever, chills, feeling exhausted, very tired, swollen of feet.
Child broke out in hives after 12month and 18month vaccines approximately 4-5 days after vaccine administration.