chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Started having fatigue the day of vaccination. Then the next day started running fever 100.9 @ 7pm took motrin 600mg . Fever broke during the middle of the night. Patient started having redness , itching, welps and swelling of the left arm(from the site to just above the elbow). This started on 1/18/21 and has continued until the present time but is starting to decrease.
Patient in observation and complains of feeling discomfort in his throat. Patients eyes puffy and red. Patients airway stable and no distress noted.  Patient given Benadryl 50mg orally. Patient monitored. Vital Signs BP-146/82, HR-78. No distress noted after monitoring. Patients puffy eyes decrease. Patient verbalizes feeling better. Patient stable.  Patient educated  and advised to call 911 if  symptoms worsen. Patients wife drove.
No AE/PQC reported at this time; improper storage of product in use; This spontaneous report was received from a physician referring to an 18-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in June 2021 (reported as between 03-JUN-2021 and 04-JUN-2021), the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1659422, expiration date 04-SEP-2022), underwent a temperature excursion below 2 degrees Celsius (C), at -51.0 C) for 14 hours. On 09-JUN-2021, the patient was vaccinated with the improperly stored vaccine (dose, frequency, route and anatomical location not reported) for prophylaxis. No adverse event (AE) was experienced. No previous temperature excursions were reported, and a digital data logger was not involved.  This is one of several report provided by the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA002504: US-009507513-2106USA008011: US-009507513-2107USA002641: US-009507513-2107USA002967:
FEELING LIGHTHEADED AND FOGGY. ETA 10AM FEELING NAUSEA , SHAKY AND SWEATY. DISCOLORATION IN FACE STARTED HAPPENING AND HEART WAS FEELING FAST. PER EMPLOYEE FEELING LIKE FAINTING.  ICE PACK WAS APPLIED TO FACE/HEAD, DRANK COLD WATER, JUICE AND HAD A PIECE OF CANDY. 15MIN AFTER, PER EMPLYEE FELT BETTER.
Small bruises on different part of body; There is pain and the experience of being remote from my surroundings-fog lke.; pain; lethargy; graying of vision; I also have had headaches unlike any experienced before.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Environmental allergy (Numerous Environmental Allergies), Asthma since 15-Dec-1947 and Hypothyroidism. Concomitant products included CALCIUM CITRATE from 15-Jun-2019 to an unknown date for Bone disorder, THYROID (ARMOUR THYROID) for Hypothyroidism, DOCUSATE SODIUM (COLACE) from 30-Nov-2017 to an unknown date for Stools hard, MAGNESIUM CITRATE from 30-Nov-2017 to an unknown date and VITAMIN D NOS from 15-Jun-2019 to an unknown date for Supplementation therapy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (I also have had headaches unlike any experienced before.). On an unknown date, the patient experienced CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision). At the time of the report, CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain) and HEADACHE (I also have had headaches unlike any experienced before.) had not resolved and LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive for Covid 19.         Patient says she has Headache behind eyes and nose, graying of vision, sensation of being remote from surroundings and lethargy. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant FU : Patient details, product details, concomitant medication , event outcome updated
Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness.
This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, liquid PEDVAXHIB, (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started feeling sick to his stomach and then threw up. Patient's face started to swell. Gave pt 10ml of diphenhydramine 12.5mg/5ml at 4:15pm. EMS arrived and patient's father refused ambulance ride. The swelling in face was receding
I had fever, chills, lack of appetite. I slept a lot. Main thing was the fever. I experienced that for 2 and a half days.
Mom, called with concerns about Patient who received one vaccination today in her left arm. She developed two small welts on the left arm about 2 hours after the vaccine was administered however, the welts were not near the injection site. She now has 5 or 6 large welts on other areas of her body. One large welt on her leg, one on the neck, another under her chin and one on her back. Mom wonders if the welts are a common reaction to Menactra vaccine. Patient had her first dose of Menactra in 2015 and she did not have this reaction. Patient is very allergic to peanuts and even the residue on surfaces has caused her to have hives up to two weeks after the surface was touched by a peanut consuming individual. Mom wonders if she came into contact while in the office with a surface contaminated with peanut residue. Patient told Mom that she saw another child entering the building as she was leaving and he was eating peanut butter pretzels. Patient took 25 mg Benadryl 3 hours ago. Advice given to give another 25 mg Benadryl now and continue with 50 mg Benadryl every 6 hours as needed for hives. Mom has EpiPen on hand and is aware of the need to use it for cough, wheezing, shortness of breath, swelling of the tongue or vomiting. Will ask Dr. if VAERS report is indicated and whether MenB vaccine would be recommended at age 17/18 years. Mom agrees to call back tomorrow morning with an update on Patient's hives, to the ER for concerns of anaphylaxis or worsening hives.
The vaccine expiration on the vial indicated 20Dec14 but was misinterpreted and entered into database as Dec 14, 2020. There is no universal standard for showing expiration date. Some countries report dates as "year/month/day" while in this country it is more commonly reported as "day/month/year" or simply "month/year". This led to misinterpretation of the expiration date.
started the 2nd day after the shot. I was slight head head, stomach, achy all over. This week i have just started to feel better
When I woke up the next morning I had a stuffy nose and sore throat. I also felt all over muscle soreness/fatigue. As the morning progressed I then noticed hives on my face that were itchy. symptoms lasted mostly thru friday, December 3rd.
On 4/13/99, patient stated that after taking second oral Typhoid with in 2 hours got worse flu she's ever had. Fever, chills, body aches, kidney pain, throat closes up; had to sit up to breathe all night. After calling the manufacturer and explaining risk to patient of taking 3 tablets, she took Benadryl and took tablet. States no problems.
I have chills all night, which I was expecting based on my reaction to the 1st shot; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had chills all night, with reaction to the 1st shot. This case is linked to the case US2020AMR045696, reported for the 2nd dose.
fatigue Narrative:  Patient called COVID-19 vaccine adverse event hotline to report experiencing diarrhea, light headache, and fatigue as a result of the second dose of the Pfizer COVID vaccine. The patient is since feeling better, but reports testing positive for COVID-19 (he got tested after being exposed to members of his household who tested positive) on 3/31/2021. The patient is self-isolating and feeling well. He states he will reach out to his primary care provider for further instructions.
Infection in arm began 2-3 days after H1N1 shot. Possibly due to lack of alcohol wipe prior to administering shot of H1N1.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received PNEUMOVAX23 (lot # K007826, expiry date: 03-FEB-2016) that was stored improperly. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA008456, 1509USA009767, 1509USA009766 and 1509USA009769 (same reporter link). Additional information has been requested.
Patient reports chest pain last week, that has now resolved. Was seen by PCP as well.  Currently reporting bilateral calf cramping that radiates to ankles,  and difficulty ambulating as a result. Tenderness to ankle decreased with acetaminophen. Patient also reported R hand  cramping and numbness.    Patient encouraged to go to emergency room.
Pt's mother called reported increased crying and shortness of breath. Instructed to take to emergency room immediately.
Pt received a flu vaccine on 10/15/2021 and then again on 3/22/2022.
pt recv vax; rash & fever of 103; irritable; rash lasted for 3 days; tx w/ APAP;
ADVERSE EVENTS (AES); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse events (aes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events (aes) was not reported. This report was non-serious.
Exhaustion (felt like I was hit by a Mack truck), headache, occasional sweating; treated with TYLENOL and slept; back to normal after three days.
diagnosed with  COVID-19 on last Friday on September 10.  His wife also has it.  Was sent from  home because of increasing tiredness, generalized weakness and confusion.   Apparently, he was saturating only 89% on room air at home but here he is  saturating in the upper 90s.  The patient is quite hard of hearing and appears  to be a poor historian.  He denied any headache, dizziness, chest pain.  Says  occasionally cough but does not bring up any sputum.  Denies any shortness of  breath.  No nausea, vomiting, or diarrhea.  His lab work however shows a  sodium of 112 with a baseline being around 132.  His potassium was 3.2.   Creatinine is normal at 1.1.  The patient also history of hypothyroidism, but  for some reason I do not see any Synthroid on his medication list and his TSH  is slightly high at 4.77 and a free T4 is a pending as we speak.  Chest x-ray  shows some patchy right-sided opacity, possible COVID-19 related pneumonia and  the patient was started on Rocephin and Zithromax and then the hospitalist  service was called for admission.  A nephrology consult was also obtained; and  because the patient has a change in mental status with a sodium of 112 he has  been started on 3% normal saline to be given 25 mL/h x10 hours only which is  250 mL, and we will do BMP and sodium q.4 hours.  The etiology of his sudden and  acute hyponatremia is unclear.  Patient denies drinking large amounts of water  and is on not on any new medications.  I have stopped his hydrochlorothiazide  for now also because he is hyponatremic.  Will put him on seizure and fall  precautions. On 9/24/24: Temp 102 - improving              Most likely secondary to chronic prostatitis             Procalcitonin 0.12, CRP 105             Flomax              Keep Foley at discharge, Urology outpatient follow-up             Blood Culture pending             Urine culture no growth (was on antibiotic)             Chest x-ray no new findings             Was on ceftriaxone and azithromycin             Antibiotic changed Zosyn and Levaquin             Currently continuing Levaquin             Occasional spikes can be secondary to chronic prostatitis needs long-term antibiotics. Discharged on 9/25/21
Patient complained of rash on inside of right arm from armpit to elbow. Was red with bumps. Patient tried hydrocortisone cream, to no effect. When patient tried to show us, it had already resolved (4 days after immunization).
Am 10/8 temp 100. Called MD. Also redness and swelling at inj. site (R thigh). Md rec. Tyl and hot pack. Even 10/5 increased redness, called MD sent to ER. Temp 103 at home. 10/9 sxs resolving.
Initial report received from a healthcare professional on 25 July 2012. A patient (age and gender not reported) whose medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine on an unspecified date (batch number, route and site of administration not reported). On an unspecified date, after vaccination the patient had experienced extensive arm swelling, induration and pain. Laboratory investigations and corrective treatment was not reported. On an unspecified date after 1 week, the patient had recovered. Documents held by sender: none.
This case was reported by a consumer via call center representative and described the occurrence of autism in a child female patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced autism (serious criteria GSK medically significant). On an unknown date, the outcome of the autism was unknown. The reporter considered the autism to be almost certainly related to HAVRIX. Additional details were reported as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient was diagnosed with autism. The reporter firmly believed that the aluminum contained in HAVRIX caused her daughter to be diagnosed with autism. The reporter did not wish to participate in the safety report.
Little bit of soreness; Moderate to severe diarrhea; Minimal side effects; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 006M20A and 027120A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects). At the time of the report, PAIN (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was treated for cancer in the past.  No concomitant medication information was provided.  No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis only" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in 2 weeks. Patient did not had known allergies. Patent received Anti viral Paxlovid treatment for Covid-19 from 04Feb2023 to 09Feb2023with lot number: 660133.
Narrative: 93 yo M w/ PMH significant for polymyalgia rheumatica, hypothyroidism d/t thyroiditis, HTN, CAD, HLD, asthma and GERD who presented to ED for CHF exacerbation on ~1/22/21 after having received the COVID vaccine (Pfizer) dose 1 on 1/16/21. Per MC note on 1/31/21, pt talked to pt's son and it was reported that before the vaccine, pt was doing ok. walking around...about 3 days after the vaccine, sharp decline and noticed to have confusion and inability to walk. Series of events include: on 1/20 was noticeable decline. on 1/21 was wheezing and collapsed 1/22 had CHF and was admitted for 1 day. Pt's son reports that since pt was home, all he wants to do is sleep' and he gets incontinent . Per PCP, it is not clear to me that this CHF exacerbation is related to COVID but i am cancelling 2nd clinic per their request (i also placed ADR). Of note, clinic may also be coordinating care; however, notes not found on record.
I mostly had thick mucus, sinus pain, congestion ,and a little cough. I  tested positive at home for COVID-19. I took mucinex and Sudafed. I called the doctor and was prescribed Paxlovid. I had to go to the ER because I was having chest pain. After I was done taking Paxlovid I tested negative  on the 16th and then on the 22nd I tested positive again. I had the same symptoms as before and I tested negative on the 29th. I still have more nasal drainage than before.
I felt like I could not breath, could not take a full breathe 04/01/2021. Later the same day I started getting a fever, and was very tired. By the next day the fever was high as 102 for a few days with severe fatigue, and short of breathe when walking for 2-3 days after the vaccine. I took over a month to build back up my energy. It took till middle of June till I felt of normal feeling.
Onset 4/11/15. Pt states she noted her arm to have a knot at the injection site and arm was swelled. Also noted as she called skin that looked "mottled" inside legs, rt buttocks. Went to MD Monday 4/13/15 had blood work done all ok.
Approximately 1 day after my 2nd dose, I noticed my lymph nodes were swollen and it was unusual for me and it was very painful. I went through it for 1 week. I did not get any treatment for it, and it just subsided on its own after a week.
Approximately 4-5 hours after vaccines, (+) hives on Bilateral legs (no respiratory or GI Sx's). Hives resolved spontaneously.