chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 78y.o. female with a pmh of IDDM,  pAfib (on warfarin), HTN, HLD, and s/p mitral valve replacement (2018) presents to the hospital after a fall. Xrays on admission significant for mildly displaced superior and inferior left rami fractures with comminuted left sacral fracture. Orthopedic surgery was consulted and is not recommending surgical intervention with just outpatient follow up. Patient is weight bearing as tolerated. Pain was managed with Ultram 50 mg q6h PRN and Tylenol PRN. Patient was also diagnosed with severe lumbar spinal stenosis 2/2 chronic degenerative lumbar spine disease. Patient did not have any concerning neurologic symptoms, loss of bowel or bladder, or saddle anesthesia. Patient is to follow up with ortho spine as needed as an outpatient for further evaluation. Patient was found to be incidental COVID positive, initially not symptomatic, however patient became septic and subsequently symptomatic with fever, chills and an AKI. Given IVF bolus and maintenance fluids for 24 hours with resolution of AKI. ID consulted and patient completed 3 day course of Remdesivir. In addition, patient also got one dose of Ceftriaxone in ED for asymptomatic bacteriuria and subsequently developed a diffuse full body erythematous itchy rash. Improved with 2 doses of steroids, PO Benedryl, and Triamcinolone cream. Patients insulin regimen was adjusted while admitted as having gotten two doses of steroids caused her BG to go up into the 400s. This improved after being taken off steroids. Patient was determined not to be an IPR candidate as she is COVID positive and will need to got to a SAR facility upon discharge. Patient is stable for discharge to SAR facility at this time with the following discharge instructions.
Vomited multiple times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- unknown, Dose number unknown), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomited multiple times". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
began 7/14 - fever began 7/12 - behavioral changes - violent tantrums began 7/18 - all over body rash
Day after booster, sore arm, body aches. Days 2,3,4,5,6 experienced flu-like symptoms, 101 fever, congestion. Negative Covid test. Day 7 feeling better, then that evening base of scalp & back of neck became itchy. Woke up the next day with a swollen left eye & widespread hives/welts all over body, extremely itchy. Also felt like a huge lump was in my throat/heartburn-like. That continued for a couple of days & then went away. Rash continued throughout the week on scalp, ears, literally head to toe. Completed 5 days of prednisone (Tuesday - Saturday). Currently taking Zyrtec 2x/day to keep itching / hives at bay. Today is day 9, body gets blotchy after showering & randomly throughout the day. Yesterday & today I felt the lump in my throat again. Very uncomfortable, but not as sever as at the onset.
Patient arrived for second dose of vaccine and verified name and DOB, patient responded negative to using immunisuppressants, having COVID in the past 90 days and any other vaccinations in the past 14 days. Pt also responded negative when asked if she had  ever had a severe allergic reaction to anything ever.  Per nurse, in observation, pt notified staff that she started to get hives and had some shortness of breath and carries an epi-pen on her. Per nurse patient wasn't observed to be short of breath at all and was talking just fine. Regardless, patient did not want EM S attention and confirmed she felt ok before leaving facility. Patient's husband was driving her.  Pharmacist notified after pt had left.
Received PREVNAR 13 on 6/16/2016 in left arm. Began experiencing itching skin and difficulty lift left arm 2 days later. Treated with topical Triamcinolone 0.1% cream. Returned to office 6/30/16 with continued left arm pain, headaches, sweats, pain into (L) axilla, (L) side of back and neck. Ordered labs: CRP, ESR, CBC, Blood culture. Prescribed AUGMENTIN. Pt still with pain on 7/5-ordered CT soft tissue LUE.
Sore arm; Little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 76-year-old male patient received BNT162b2, as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Little fever". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: The patient experienced nothing more than a sore arm and a little fever maybe, but no rash or no breathing problems. Just a local reaction. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/product/AE, different patient;
Temp 104, stomach ache, no vommiting @ 04:00 on 04/17/2003.  Temp down to 100 by noon with Tylenol and stomach ache down.  No steady state as of 04/18/2002.
sick; fever; chills; body aches; This is a spontaneous report from a contactable healthcare professional.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for Covid-19 immunization. The patient is a healthcare worker and she had the corona virus on 23Nov2020. The patient's concomitant medications were not reported. The patient received the Covid vaccine on 18Dec2020. On an unspecified date, the patient got really sick after the first vaccine with fever, chills, body aches, etc. The patient was scheduled to receive the second dose on Friday, 08Jan2020, the patient asked if the patient should still take the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Case number PHHY2012US051995 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination, she had kidney failure. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after administration of INFLUENZA vaccine.
65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea.  Patient died 18 Aug 2021, COD COVID-19 pneumonia.
After both the initial and this second shot, I experienced cramps or tightness in muscles in arm. It was actually more pronounced with first dose. Started in right scapula, then moved to elbow, then to wrist. Symptoms gone after ~30-40 minutes.
This spontaneous report as received from a health professional refers to a 13 year old patient of unknown gender. On 27-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all correspondence was received.
Shortly after receiving GARDASIL vaccine developed a rash described by parent as diffused with hives, diff. breathing. BENADRYL 50 mg given at home. Pt. seen at the ER at 6:30pm- no hives present, itching, pallor, tachycardia. Given SOLUMEDROL, improved and sent home.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/18/2023 HYPERTENSIVE HEART DISEASE WITH HEART FAILURE
Varicella vaccine received on 1/04/07 along with influenza vaccine.  Mother reported seeing a couple spots on his chest, back, and diaper area on 1/06/07.  Mother stated rash increased on 1/07/07, but it was totally covering his chest, back, and diaper area on 1/08/07 with itching.  Child was taken to family MD on 1/08/07, and physician verified the rash as varicella.  Treatment was for symptoms:  Tylenol was ordered for temperature, and Benadryl liquid for itching.
Lymphedema right underarm and breast  Treatment- ice, ibuprofen, acetaminophen, light massage and light exercise
This case was reported by the wife of a consumer and described the occurrence of feeling unwell in a male subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Diphtheria tetanus acellular pertussis, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Diphtheria tetanus acellular pertussis. At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced feeling bad/unwell. At the time of reporting the outcome of the event was unspecified.
Couldn't move arm post 2; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine) outcome was unknown.            No concomitant products were reported.  It was reported that, post first shot had sore arm and week later rash at injection site. Post second shot, couldn't move arm post 2 hours, migraine that night.   No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624798.
very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included CAPSAICIN, MENTHOL (ALLEVESS), ACETYLSALICYLIC ACID (BABY ASPIRIN), INSULIN, METFORMIN, SIMVASTATIN and LISINOPRIL (LISOPRIL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient acquired some pain and swelling of the right arm and a patch of the arm described as about 1"x2" turned a light pink color about 1 - 2 days after injection. It was not red or hot to the touch. She applied some ice for the pain and inflammation on 6/19/19 and today the arm is less painful and the pink has receded some.
Complete Loss of Hair onset within the first 3 days of the immunizations.  (Alopecia Totalis).  Total hair loss onset rapidly over the course of of the following weeks.
Information has been received from a licensed practical nurse concerning a 15 year old female with migraines and no known allergies or adverse drug reactions reported. On approx 8/31/06, the pt was vaccinated with the first dose of HPV vaccine. On an unspecified date, the pt was noted to be positive for an unknown number of high risk human papilloma virus types. The pt underwent a pap test (date and results not reported). The pt sought unspecified medical attention. a colposcopy was planned for the pt. At the time of this report, the pt had not recovered from the event. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a licensed practical nurse concerning a 16 year old female subject with migraines and no known allergies or adverse drug reactions reported. On 24-AUG-2006, the patient was vaccinated with the first dose of GARDASIL. On an unspecified date, the patient was noted to be positive for an unknown number of high risk human papilloma virus types. The patient underwent a PAP (date and results not reported). The patient sought unspecified medical attention. A colposcopy was planned for the patient. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
ACHES; SLEEPLESS; CHILLS; JOINT PAIN; HIGH FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sleepless, chills, joint pain, high fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pain, sleepless, high fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
This spontaneous report was received from an office manager and refers to a 14 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
1/27/22  67 yr/o male who presents to the Emergency Department with a change in mentation.  EMS reports family called EMS today because patient came to their house which was unusual for him.  They felt as though he was more confused and having difficulty speaking.  They also noted that he had damage to the side of his car and patient could not recall any accident.  EMS reports that family states that he has had some mild change in his mental status for at least 2 weeks but it is more severe today.  There is no last known normal.  Patient mentioned something about Covid but cannot tell me if he has been tested or been told he has been exposed or positive.  1/31/22 Discharged to home with home health and hosparus HH
Pt recvd vax 23OCT02 & on 1FEB93 a blood culture showed growth of haemophilus influenza type B; addtl into has been requested;
Tachycardia, chest pains, pulsating heart, abnormal blood pressure, seizure type activity, treated with the IV at the Emergency Room for approximately 4 hours, then released. Following that the tachycardia has not subsided, pulse over 100 24/7 and chest pains, increased seizure activity.
@10:17am Patient reported rapid heart rate and difficultly breathing and she felt like she was going  to faint, I took her vital signs and bp: 178/112, PR: 155, o2: 100%
Extreme headache/migraine, fever, chills, body aches/pains, soreness at injection sight, fatigued within 6 hours of receiving the injection and symptoms gradually worsened over the course of two days.
Arm sourness for one and a half days.  'Punctured' feeling for as long, distinct from general sourness. Dry mouth starting almost immediately from time of shot till one day later. Tiredness for about 20 hours, despite sleeping for 6 hours twice. Fatigue/drowsiness for about 30 hours. Loss of apatite for about 32 hours (about 1400 calories consumed with meals left mostly unfinished). Unusually high depression and generalized anxiety (not mostly about shot side-affects, but mostly existential) for about 28 hours. Runny nose for about 8 hours. Elevated sneezing for about 4 hours.
13 year old patient should have received Pfizer but Moderna was inadvertently given instead. No extra adverse events at this time.
Injection site began to swell this morning with a discernible lump. Previously, the swelling had almost completely subsided. The site is now slightly red again and feels slightly warm to touch. The injection site has also begun to itch.
Rash developed 10 days after vaccine and was a possible amoxicillin allergy. Then 14 days after the vaccine a bright red confluent rash developed only on the arms & legs with some spots distally on hands & ankles (+) itch. BENADRYL prn.
no adverse event.  Patient was only given the diluent part of the Pentacel vaccine.  The diluent was never mixed with the powder vial.  Nothing happened to baby.  When doing inventory, I caught mistake and notified provider as well as the patient's mother and she is bringing patient back in on 6/8/2023 for repeat Pentacel Vaccination.