chrisvoncsefalvay/vaers-outcomes huggingface dataset:
#3 DOSE PFIZER COVID VACCINE GIVEN 10/24/21, #FF2593; #4 DOSE COMIRNATY COVID VACCINE GIVEN 6/28/22, #FM0173; pt brought to hospital from rehab on 7/16/22; found to be positive for COVID; COVID pneumonia; streptococcal pneumonia; streptococcal bacteremia; septic shock; volume overload; ABX; "COVID treatment" (specifics not noted in medical record); GI bleed; PRBCs transfused; high flow O2 via NC; dc'd to rehab on 8/6/22; 8/10/22 pt brought back to hospital with lower abdominal cramping and poor oral intake; on BiPAP; ICU; colitis with sepsis; hypotension; hyperkalemic with heart rhythm disturbances; pneumonia and septic shock; pt is DNI; respiratory status worsened; pt transitioned to DNR; she passed away in the hospital
age 8 had mild injection site pain; mild injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "recovering", described as "mild injection site pain"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 06Oct2021, outcome "unknown", described as "age 8 had mild injection site pain".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Vasovagal response HR decreased 54 BPM. Pt placed in a supine position until able to determine if stable. Monitored w/ O2 Sat. Continuously monitoring in room VS taken.
PARTIAL DOSE ADMINISTRATION; NEEDLE GOT UNSCREWED FROM THE SYRINGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced partial dose administration. On 12-APR-2021, the subject experienced needle got unscrewed from the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administration and needle got unscrewed from the syringe was not reported. This report was non-serious.
Nurse administered Jynneos vaccine via intramuscular route into the right deltoid. Dose was not re-administered. (DON of DPH Vaccine Preventable Disease Program) was contacted, and she advised not to re-administer the vaccine based on CDC interim guidance.
Itching, redness and slight pain at the injection site 8 days after the first shot.  My arm is warm/hot in the area and feels more stiff than my other arm in the same spot.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who was vaccinated IM, on an unspecified date with the third dose of Gardasil, and subsequently felt dizzy when going to the parking lot. The patient called the nurse, who brought her back to the office, and the patient then fainted. The patient's mother was called to get her, as she was unable to drive. The physician sought unspecified medical attention. Additional information has been requested.
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
I started having foot pain in my right foot  during February 2021, prior to the vaccine. I self treated for plantar fasciitis but no improvement.  Saw a podiatrist and was given a cortisone injection for plantar fasciitis on March 29. 2021. Felt fine until mid June 2021. Right foot pain again but on bottom of heel this time. Saw podiatrist again 7/13/21. He recommended gel cup inserts for my walking shoes. The heel pain got worse over the next several weeks. During this time I also noticed the fuzzy/leathery feeling in my toes sometime during June or July 2021. Thought it was related to the foot pain and dismissed it.  As heel pain grew worse, saw podiatrist again on August 24, 2021 and was given a cortisone shot for bursitis. I asked him about the fuzzy feeling in my toes and he said this was not from anything in my foot but likely a nerve problem in my spine. By this time, the fuzzy feeling had also spread to the bottoms of my feet on an intermittent basis. I then saw my PCP, 8/26/21.  He ran bloodwork to look for any issues. Everything came back fine so he referred me to see a neurologist on October 25, 2021.
AS PER FATHER SITE OF INJECTION WAS RED AND SWOLLEN, ITCHY AND CHILD FELT A LITTLE PAIN. NO HIVES, NO FEVER, NO DIFFICULTY BREATHING. FATHER WALKED IN WITH DAUGHTER THE NEXT AM DAY. AS FOR DR. WHO SAW PT. ADVISED TO SEND IN REPORT. NO F/U WAS NEEDED.
Initial report was received from a consumer, who was also the patient, on 06 January 2012. A male patient (age and date of birth not reported) had received an injection of an influenza vaccine (trade name, manufacturer, lot number, route, site and date of vaccination not reported) and an unspecified amount of time later started sweating and "the next thing he knew he was on the floor." The patient reported that the health care professional (HCP) mentioned that his blood sugar dropped in the 20's. The patient's concomitant medication included HUMALOG. Illness at the time of vaccination and pre-existing medical conditions were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
local rxn erythema, swelling, tenderness, pruritus;tx DPH, ice, ASA;systemic-flu like sx;spontaneous resolution;
103 degree fever.  Full body rash.  Watery/runny eyes.  Began evening of day vaccine received and lasted for 2 1/2 days.  Chronic diahrrea began that night and lasted for 10 months.  Weight fell off the charts completely.  Some stomach issues persist to this day.  Loss of language within 3 weeks of vaccine.  Some speech delay as of this date.  Irritability and reflux symptoms within 1 month of vaccine.  Treated as a milk and soy allergy.  Removed dairy and soy protein from diet with no change in symptoms.
ON 5/5/21 17 YEARS OLD MALE CHILD WAS GIVEN MODERNA VACCINE. TODAY SECOND DOSE WAS GIVEN FOR COMPLITION AS RECOMONDED
Patient noticed skin tenderness on right breast. Itching and pain increased in initial affected area but began symptoms on back and armpit. ER visit on 3/28/2010. Diagnosed with Active shingles case and treated with valacyclovir 1 gm bid x10d. Contacted our pharmacy 4/7/2010 to report her adverse event. Report entered 4/7
nose bleeds times 2, nausea, vomiting, diarrhea, upset stomach, abdominal pain, tiredness, pain at injection site.
got his first dose of Havrix in Oct2019 and never received a 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Havrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
No additional AE/PQC.; HCP reporting that PROQUAD was administered after it experienced a supported temperature excursion; This spontaneous report has been received from a medical assistant and refers to a 4-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 25-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at dose of 0.5 milliliter (lot number X002296 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 21-JUL-2024) administered for prophylaxis, after it had experienced a temperature excursion (product storage error) (strength, and anatomical of administration were not provided). The temperature excursion occurred within a timeframe of 1 hour and 36 minutes, at a temperature of -12.6 degree Celsius (C). No adverse events were reported.
Patient given Fluzone High Dose indicated for 65 and older.  Patient is 58
Low grade fever with serious seizures (shaking, rolled eyes, locked jaw, foaming at the mouth), difficulty breathing. 911 call was made and paramedics took my son to the hospital. He was on the observation until the rest of the night and released to the home where subsequently he developed a rash.
had the glucose come higher; has numbness on right side in her fingers and in the middle of her right hand; stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 at 17:00 (Lot number: EW0171) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 05Nov2020 (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Taking for a long time, more than 20 years; "High blood pressure" (unspecified if ongoing), notes: diagnosed more than 20 years ago ; "Glucose" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); CETIRIZINE taken for hypersensitivity (ongoing); MONTELUKAST taken for hypersensitivity; GLIFAGE XR taken for blood glucose. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: RS737), administration date: 06Apr2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 03Sep2021, outcome "unknown", described as "stroke"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "had the glucose come higher"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "has numbness on right side in her fingers and in the middle of her right hand". The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) unknown results, notes: Normally it is 7-100 or 90-110; (10Jan2022) 268, notes: the last glucose was 268; sars-cov-2 test: (unspecified date) positive, notes: Yes I did test last week; (unspecified date) positive, notes: I did test this week it is positive.   No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported fever and chills, dizziness of evening of day of vaccination.  The next morning she described what sounds like a tremor of intention, when she reaches for glass or tries to do something with her hand, it jerks.
Mum  reported today  pain, inflammation, and bruising at site of injection since it was given on friday so she sent patient over. When patient came I observed the injection site was bruised and darkened but did not see swelling. I advised patient to take tylenol for the pain and see if things improve by tomorrow.
An 87 year old male pt was started on a second course of Oncotice for bladder cancer since 6/10/05. On an unk date, he experienced a cough, which is ongoing.
Severe leg pain in both legs. Was admitted into hospital for two days. No medication worked to treat this symptom.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:16 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 36.27 for dose administered on 27-Feb-2021 and 36.35 for dose administered on 27-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit from 09:00 AM to 11:00 AM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
sore arm post injection; ADACEL looks yellowish brown in the syringe; two dose of ADACEL vaccines within 3 months; Initial information  was received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who experienced adacel looks yellowish brown in the syringe, two dose of adacel vaccines within 3 months and sore arm post injection while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 1 dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On 14-Oct-2022, the patient received 2nd dose (lot-C5788CA)  unknown route in the left arm.  On 14-OCT-2022 the patient developed a non-serious adacel looks yellowish brown in the syringe (Poor quality product administered) and two dose of adacel vaccines within 3 months (inappropriate schedule of product administration) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date the patient developed a non-serious sore arm post injection (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that "ADACEL can be administered the day of the expiration date listed on the bottle, if the ADACEL looks yellowish brown in the syringe if it was safe to administer, and if it was okay for her previously unvaccinated son to receive two ADACEL vaccines with in 3 months.The patient had received his initial ADACEL vaccine 3 months prior and the mother was advised by an alternate pediatrician that he should have received the 'TD' instead of the ADACEL moving forward".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  Corrective- Unknown for pain in extremity  At time of reporting, the outcome was Unknown for all events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My arm in not longer sore from the injection , However I continue to have a tingling from the injection  spot  down my left arm  into my  fingers . It feels like a nerve problem in my arm.  It has been over a month and the problem has not gone away
Suspected vaccination failure; got them again/ it was less severe than the first time; was less severe than the first time, but itched just the same; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pruritus.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got them again/ it was less severe than the first time) and pruritus (Verbatim: was less severe than the first time, but itched just the same). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 The case was received from the patient via interactive digital media. The patient had them previous to getting the first shot, then got them again between the first and second dose. There was a supply problem with the second dose, it was less severe than the first time, but itched just the same. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sinus headache/pressure, body ache, stuffy but runny nose, chills, low energy, sore arm at injection site.
Seizure and resulting concussion after hitting steel post & concrete floor while at work exactly 2 weeks after vaccinated - at almost exactly the same time of day vaccinated. Gash on nose.
Pain, Swelling and Redness, warm to the touch, below the injection site at the Deltoid all the way down to elbow.
Change in voice, mild tightening, persistant cough and hives. Anaphylactic - MD Transient Global Amnesia.
The patient is a 90 yo male who was admitted on 1/6/2022 for chief complaint of fall with left hip pain. Patient has past medical history of HTN, Marfan syndrome, and CAD. Patient was found to have a left hip fracture. He underwent cardiac clearance and was started on metoprolol by cardiology and subsequently underwent ORIF with orthopedic surgery. He had incidental finding of Covid-19 on screening prior to surgery. Patient is vaccinated and has received his booster dose as well. He initially did not have respiratory symptoms but did develop hypoxia and was placed on supplemental oxygen and treated with dexamethasone and remdesivir. He was evaluated for home O2 and did qualify. PT/OT recommended post acute but patient declined and will return home.