chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of 1/9/22 I began experiencing itching and hives all over my body; chest, legs, arms, back, and neck. I thought it was due to bug bites as I had been outside for a few hours. However, the hives would disappear and reappear later. I also could not sleep through the night from 1/9 through 1/12; I would wake up extremely itchy all over and find more hives. On 1/12/22, I began experiencing intense itching on my upper back, and when I looked under my shirt, I was red all over my upper shoulders and there were raised lines all over in the shape of where I had been scratching. After some searching, it appears I have symptoms of dermatographia. I began taking a 24-hour Zyrtec every 24 hours since 1/13 at 8:25 am. This helps with the intense itching, but I am still experiencing the dermatographia as of today 1/17/22, just without intense hives.
pt recv vax 14NOV96 5PM & mom called on call MD to report a lot of fussiness, high pitched cry-persistent & refused formula but took pedialyte;mom gave APAP, DPH, tmax 100.3;nl PE @ 10AM afeb, taking formula now;
Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of Pfizer COVID-19 Vaccine Lot# EL8982 at location on 01/25/2021 @ 10:30. On 01/28/2021 pt started feeling chills, which resolved in 2-3 weeks. Pt started feeling back pain around 02/15/2021, went to Clinic  around 02/17/2021 for the pain. The 2nd dose of Pfizer vaccine was due on 02/17/2021, pt had to cancel 2nd dose appointment due to Clinic appointment. Clinic staff told pt back pain was most likely due to a pinched nerve or lower back problems that comes with age. No x-rays or blood work was performed at Clinic. On 02/21/2021 pt stood up and felt even worse lower back pain, couldn't walk, pt went to  ER and was admitted for 5 days, discharged 02/26/2021. Blood work was done and showed hyperkalemia, proteinuria, and kidney failure, upon discharge ER staff told pt to follow up with nephrologist. Nephrologist appointment is scheduled for 04/01/2021. Pt takes Morphine sulfate IR 15mg, Atenolol 50 mg, Fenosteride 5 mg, and Terazosin 10 mg. Pt has Myeloma, Hypertension, and Benign Prostatic Hyperplasia. Caller denies pt has any allergies. Pt will receive oncology treatment 03/29/2021, the oncologist alerted the caller the 2nd dose must be administered to the pt before oncologic treatment. Caller asked if the pt should get the second dose due to the kidney failure occurring after the 1st dose was administered. Currently pt is only experiencing lower back pain. Pt was advised that it is unlikely the vaccine caused kidney failure and the pt should get the second dose as soon as possible. SPI was consulted and Dr. was notified.
Second dose at 9am 4-15-2021 9am- vaccine administered at 9:10 916- heaviness in head 11am- fatigue low level  2pm- heavy fatigue. Soreness arm.  4pm- nausea and headache  5:30pm- vomiting  745pm- vomiting and headache severe. Chills started 815pm- vomiting  930pm- vomiting  1005pm- vomiting. No chills.   Friday April 16, 2021 1:30am- chills back no fever 4am- no chills  5:30am- chills no fever  7am- woke slight headache and mild body aches. Low energy  12noon- aches worsen  4pm- headache and aches more significant. Heavy fatigue. Chills on and off   Saturday April 17, 2021 1am- woke up same symptoms since 4pm. Headache throbbing.  Slept until 11am which is very unusual  Noon- headache mild. Body aches/pain significant continue. Fatigued.  6pm- woke up after sleeping since 130pm. Headache mild and significant aches/pain continue.  10pm- no headache. Body aches/pain significant. Took a bath to relive aches which helped some.   Sunday April 18, 2021 12am- body aches significant return 9am- woke up with significant aches/pain still  Tried to move around & cook breakfast.  11:00am- aches/pain worse after moving & cooking. Rested and slept until 3:30pm 4:00pm- pain significant. Took hot bath helped some. Tried stretching. Pushed fluids.  11:00pm-8:00am slept.   Monday April 19, 2021 2:00am- woke in a sweat which is unusual 8:00am woke sweaty which is unusual and no muscle pain. More mild muscle aches.   Most significant and distressing reaction was the vomiting due to intensity, duration and frequency
Unexpected menstrual period - I am currently on Lo Loestren Fe for birth control. I have not had a period in 15 months since I started using this pill. 11 days after receiving the vaccine, I had cramps and a heavy period which lasted 7 days.
Initial information received on 18-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves an adult female patient (age was not reported) who experienced cellulitis, while she received vaccine INFLUENZA VACCINE (unknown manufacturer). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a serious cellulitis, 1 day following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No lab data reported. Final diagnosis was cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for cellulitis. Sender's Comments: This is a poorly documented case which involves an adult female patient who experienced cellulitis after vaccination. Time to onset is not properly known to decide the compatibility with the role of vaccine. More details regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Acute localized pain, redness and swelling @ site of injection. Persistent L wrist arthralgias
I went to the Nursing Home and got my Covid shot. Immediately, I had tingling around my lips and tongue. I waited 30 minutes and then went home and started working. Several hours later I started shaking, muscle twitching felt that I was about to have seizure. I was having tightness in my chest that radiate to my back. Affected my vision. The following day I have diarrhea. The tightness of chess, muscle twitching, and shaking lasted for 7 days. I went to see my neurologist first and then a couple days later I went to the ER. I was there for about 5 hours and they ran a lot of tests that came back with no diagnosis. After the 7th day I started getting better.
Slightly sore area starting on day after through day 3, moderate fatigue on day 2 (March 20) only
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-FEB-2016, the patient was vaccinated with the improperly stored dose of VARIVAX (Merck) (lot # L027288, expiration date 21-JUL-2017; dose and route were not reported). The vaccine was stored in 0.5 degrees of Celsius for 2 hours and 18 minutes and in 3.6 degrees of Celsius for 3 hours and 6 minutes. No adverse effects were reported. Additional information has been requested.
Fever of 102.4 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102.4 Fahrenheit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma and Drug allergy (Lot of allergies to prescription medications). Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE (HCTZ), SPIRONOLACTONE, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (Fever of 102.4 Fahrenheit). In February 2021, PYREXIA (Fever of 102.4 Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102.4 (High) 102.4 Fahrenheit.         No treatment medications were reported.   This case was linked to MOD-2022-438642, MOD-2022-438684 (Patient Link).
Pt was admit to hospital 9/25 for CHF. Pt rec'd pneumococcal vaccine IM in R arm 9/27. Pt rec'd influenza vaccine IM in R arm 9/26. Pt developed 3+ edema, with bruising and swelling on R arm/shoulder, rx'd cleocin for cellulitis, warm compresses, ultrasound showed complex mass either hematoma vs abscess. 9/30 surgical consult, but I&D was not needed. At time of discharge on 10/5, pt arm/shoulder was improved, pain improved, but the hematoma still remained but is expected to resolve in a few weeks.  10/21/2009 Medical records and discharge summary received for DOS 9/25-10/05. FINAL DX: Acute diastolic congestive heart failure, severe mitral regurgitation and moderate tricuspid regurgitation, right upper extremity hematoma and edema, improved, chromic mild hypothyroid anemia, hypertension with a history of orthostatic hypotension, history of prostate cancer status post prostatectomy followed by radiation, coronary artery disease status post coronary artery bypass graft 30-40 years ago, history of bilateral carotid endartarectomy, iron deficiency anemia status post transfusion on unit packed red blood cells, mild acute renal failure, creatinine stable at 1.4, history of heme-positive stools   Admit through ER on 9/25 with increasing resp rate and SOB. Status post previous admit for gastroenteritis and possible aspiration pneumonia.  Resp rate 30-40.  O2 sat on room air 88%.  Resp rate decreased to 20 on non-rebreather.  Hypoxia and CHF improved w/tx and stable on 2L 02 nasal cannula. Normal ejection fraction. Continued mild hypertension. Heme (+) stools continued. HGB stable with one unit. Plan to monitor anemia status. R shoulder edema resolved. R shoulder hematoma resolving. Assessed baseline mild hypothermia. No s&sx sepsis.   To be discharged to skilled nursing facility rehab.
Round red, warm, elevated area surrounding site where vaccine was given. Youth complained of pain at site. Treated with Ice and Ibuprofen.
Sweating, body over-heating, dizziness, extreme nausea and loss of appetite. Chest pain, heart beat rhythm seemed odd and was taken to hospital with a heart stress test. Mild case or vertigo as well. 4 months later after 2nd shot- pap smear showed HPV high risk and abnormal result (all 2 previous paps normal) only 1 sexual partner. No way to contract the virus.
R09.02 HYPOXIA 12/9/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
developed kidney stone; This is a spontaneous report from a contactable nurse (who is also the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration in the left arm, on 31Mar2021, as single dose, for COVID-19 immunisation. There were no medical history and concomitant medications. On 06Apr2021, 6 days after the vaccination, the patient developed kidney stone which was a 6x2 mm stone. The patient stated that she never had a history of stone. She was wondering if anything has been reported like this and mentioned that she was unsure if this could be a side effect. The patient was recovering from the event. The patient reported the event as serious (medically significant).; Sender's Comments: The event kidney stone is considered unrelated to suspect vaccine BNT162B2 as there is no known plausible mechanism. The reported event most likely represented intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).
Fell while running; not sure if weak from falling or from vaccine. Next day felt very weak like if it was taking extra effort for muscles/nerves to work. Heart was racing but not continuously. Heart rate at 96 beats/minute which is odd since runner for many years. Felt shaky also. Breathing ok but if took deep breath felt woozy, lightheadedness, dizziness comes and goes. Today feel pretty good. Heart is fast still woozy. Doesn't feel like getting a cold. 11/2 called doctor but did not receive any recommendations.
A taste like rubbing alcohol lingers in the mouth on the tongue and in back of the mouth.
Feeling bad, red rash on chest and back, injection site red, hot and itchy.
Injection received 10/19/2001, at 1600 pm. On 10/20/2001 at 2:30 pm, noticed swelling and redness at left arm area. Also consist of biceps muscle aching. Described as the size of a 50 cent piece. On 10/20/2001, also developed headache and diarrhea which lasted approximately 1 day and then resolved.
This case involves a patient (unknown demographics) who had worse flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious worse flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I got my corona virus disease (Covid) shots, but I'm not doing the flu shots. I was talked into to having the flu shot once and came down with the worse flu I ever had that year." It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, outcome of the event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.
-First day slept 16 hours.  Arm ached a little, continued extreme fatigue and generally not well for 2 more days.  -ELEVEN DAYS AFTER 1st dose, sudden swollen glands and sore throat along with fatigue again for 2 days.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 15-OCT-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
Patient reported neck swelling. Patient was hospitalized due to concern for anaphylaxis. She was discharged on 9-4 with steriods. She is feeling much better.
ZOSTAVAX was administered and several days after the vaccines the patient began experiencing symptoms of shingles. Patient was treated for shingles on 10/22/17.
pt recvd vax; six wks later devel 6 lesions near inject site;
Morning of March 5th: started feeling pain at the injection site right arm deltoid. Evening of March 5th: Pain is still present. I started to rub the arm. My arm became swollen, red, hard, warm to touch, itchy and painful to move. Later that night, I also felt something in my left forearm. I started using a cold pack. Morning of March 6th: right deltoid has not changed. Now alternating between heat and cold on arm. Evening of March 6th: left forearm feels like a sore muscle after exercising. I began to flex my wrist to stretch the muscle. My left forearm then became swollen, red, hard, warm to touch, itchy and painful to move.  Morning of March 7th: Went to urgent care. I was prescribed a cream and antibiotics and told to take an allergy pill. Morning of March 8th:  Right deltoid has lessened is swelling, redness, pain and itchy feeling.  I started to feel the sore muscle feeling in both calf muscles and right forearm. I did not stretch the muscle and it has not produced the same reaction.
Fussiness was noted later in the afternoon, approximately 3 hours after vaccine.  The next day mom noticed redness in the face and a rash on the face and back.
went to the hospital for 5 days and had 5 infusions, one each day. He was diagnosed with Guillain Barre Syndrome. currently in rehab going on 3 weeks now.
Dizziness, vomiting, headaches, pain in joints, backache, aches in the arm that was injected.  Bad mood and sleepnessness.
Patient received moderna vaccine on 1/29/21, 2/26/21, 11/3/21 and 6/17/22. Presented to ER on 7/4/22 and found to be COVID positive. Presented to the ed from assisted living for 5 days of intractable nausea and vomiting found to have gastric outlet obstruction secondary to progressive carcinomatosis, aki, hydronephrosis, incidentally found to be covid positive. Endorsing decreased appetite over last few weeks and only able to tolerate small amounts of liquid for last 5 days with associated weight loss of approximately 10 pounds. Has not had a bowel movement in several days and denies flatus. Has been urinating small amounts. Reports sick contacts at the assisted living facility. Did receive a covid vaccine and booster. Denies fevers, chills, night sweats, headaches, dizziness or presyncope, chest pain, shortness of breath, dry or productive cough, abdominal pain, diarrhea, dysuria, hematuria.    Of note, patient reports she was supposed to start salvage chemo this Wednesday, but reports she probably won't be able to now due to significant weight loss and being unable to tolerate PO. Discharged on 7/6/22. No oxygen needs or COVID19 treatment
Patient Developed a high fever the day of the vacines. After I noticed a diference in his whole self he shut down started banging his head with violent mood swings. He became withdrawn antisocial and started in on other behaviors such as biting, pulling hair, so I switched daycare. At the next one he was overtaken with the doors (open and closing) so they said he was a safety risk and that I should have him tested. So I did.  5/20/08 Reviewed PCP medical records & vax records of 8/2003-3/22/2007.   FINAL DX: autism spectrum disorder, PDD, developmental delays, hyperactivity. Records reveal patient experienced recent strep on day of vaccination.  Next visit note is for 4/04 & pt doing well but being treated for strep.  In 11/04, pt seen for strep recheck & parent requested testing for PDD.  Exam revealed loss of eye contact & unable to follow simple commands.  Parents reported tantrums, picky eater, aggressive behavior, social withdrawal, hyperactivity, insensitivity to pain, inappropriate attachment to plastic toy, sleep disturbance w/screaming, head banging, hand flapping & sustained odd repetitive play.  Dx w/developmental delays & referred to peds neuro.  Neuro consult of 12/2004 dx w/autism spectrum disorder.  Patient to receive early intervention services.
weakness; leg pain; diarrhea; burn when urinate; vision blurred; my arm got a little sore; leg pain; everything looks kind of fussy; joint pain; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate) and VISION BLURRED (vision blurred) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), the first episode of PAIN IN EXTREMITY (leg pain), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the second episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), DYSURIA (burn when urinate), VISION BLURRED (vision blurred), PAIN IN EXTREMITY (my arm got a little sore), the last episode of PAIN IN EXTREMITY (leg pain), ANXIETY (everything looks kind of fussy), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication included heart medication.
Received Covid vaccine March 2021 in left arm, started experiencing weakness and tingling contralaterally in my right hand within a month.  I started dropping my purse and bags.  Weakness ascended up the arm.  Neurologist found inflammation of nerves in my arm but thought it was a peripheral nervous system disorder in August 2021.   I got referred out to the clinic - for a second opinion where I was officially diagnosed with ALS December 2021.   By then I could not raise my right arm.  The same weakness moved to my left arm and through my legs and is now affecting my breathing.  I am100% paralyzed in my limbs and can no longer breath unassisted as of November 2022
Report A0370538A describes mercury poisoning in a female child of unspecified age who received hepatitis B vaccine (brand name unknown). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The child received an injection of hepatitis B vaccine on 30 AUG 1994. She also received an injection of hepatitis B vaccine, combination diphtheria and tetanus toxoids and pertussis vaccine absorbed/Haemophilus influenzae type b conjugate vaccine; diptheria and tetanus toxoids and pertussis vaccine absorbed, diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed; oral poliomyelitis virus vaccine; measles vaccine, MMR virus vaccine. The vaccinee attorney alleged that the vaccinee experienced mercury poisoning due to vaccines administered from SEPT 1994 through at least JUN 1999. Time to onset from immunization and treatment were not provided.