chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got the flu and I took him to the doctor November 19th and did not diagnose him with the h1n1 but my husband and I were very sick for over a week. I was scared of a febrile seizure which his cousin had growing up and grew out of so I was giving motrin and tylenol rotating every three hours as doc requested. Doc said ok to give a break and within an hour these episodes started. and have increaed. now he is on seizure med and not working
Mother states developed nickle-sized area at site - red, warm to touch, plus itch.  Evaluation on 5/16/08 - right arm cellulitis after immunization reaction.  Area marked; Keflex BID for 10 days.  Mother to monitor, advised to call for continued or increased symptoms.  No call received (area 2 in x 1.5 in).
Suspected vaccination failure; Had a mild case; Yet painful; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had a mild case) and pain (Verbatim: Yet painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the vaccine due to having a compromised immune system. The patient had a mild case yet painful for a week. What made patient sad was when services came to her/his house questioning if he/she could care for her/him 10 years old granddaughter.  Little did the workers know that their boss was mine that over sees the policy boards her/him sit on.  Not only was patient case closed immediately he/she received an apology letter for undue stress due to being temporarily ill.  Be cautious of others assuming you could not care for your family. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
IMMEDIATELY FELT PAIN AT INJECTION SITE, LEFT DELTOID. THEN FELT HEAVINESS IN LEFT ARM SECONDS AFTER. WITHIN ONE MINUTE (LESS THAN A MINUTE) PATIENT WAS NEAR SYNCOPE, STARTED TO FALL OVER, PALE WHITE TO THE FACE, EYES CLOSED, HAD A COUPLE JERKY MOVEMENTS, LAID PATIENT DOWN, LENGTH OF TIME WAS 10-15 SECONDS. PATIENT OPENED EYES AND ASKED WHAT HAPPENED. PATIENT WAS UNAWARE OF WHAT HAPPENED. DOCTOR INFORMED AND PATIENT EXAMINED AGAIN. BLOOD SUGAR 80, BLOOD PRESSURE 110/64 LEFT ARM LAYING DOWN WITH HEAD ELEVATED 45 DEGREES. BLOOD PRESSURE STANDING 118/70. LATE BREAKFAST AT 10:00 AM, NO LUNCH. GAVE DR. PEPPER TO DRINK, WAITED 30 MINUTES OR MORE BEFORE LEAVING. COLOR CAME BACK IN FACE WITHIN A FEW MINUTES. LABS ORDERED CBC, CMP. RESULTS PENDING.
body ache; chills; fever; arm pain and the pain level was 8 from scale 1-10 with 10 being worst; This is a spontaneous report from a contactable pharmacist (patient). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247) via an unspecified route of administration in the left arm on 13Jan2021 at 16:45 at single dose for COVID-19 immunisation. Vaccination facility type was workplace clinic. Relevant medical history was not reported. The patient was not pregnant. Concomitant medications were none: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El1284) on 23Dec2020 at 16:45 in the left arm. On 13Jan2021, after taking the shot, the patient experienced terrible body ache, chills, fever and arm pain and the pain level was 8 from scale 1-10 with 10 being worst. Everything lasted 36-48 hours and the patient had to take 5 doses of paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with lasting effects from the events on an unspecified date in Jan2021.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 with 3 days of symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19 with 3 days of symptoms). At the time of the report, COVID-19 (COVID-19 with 3 days of symptoms) had resolved. Not Provided          No concomitant medication were reported.  No treatment medication were reported.  Patient had unspecified vaccine booster on an unspecified date in August or September 2021 also has a mild case of COVID-19 with 3 days of symptoms and didn't specify when was diagnosed with COVID-19 or when symptoms began.  This case concerns a male patient with unknown age with no reported medical history, who experienced non-serious , unexpected , AESI event  Covid 19 which occurred on an unknown date after vaccination with 2 dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a male patient with unknown age with no reported medical history, who experienced non-serious , unexpected , AESI event  Covid 19 which occurred on an unknown date after vaccination with 2 dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
Tired; vey bad headaches; body aches; uncontrollable diarrhea which lasted for 3 days; fever 102; joint pain; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (uncontrollable diarrhea which lasted for 3 days), PYREXIA (fever 102), MYALGIA (body aches), FATIGUE (Tired) and HEADACHE (vey bad headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (allergy to Augmentin lead to liver failure.) and Liver failure.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (body aches). On 02-Mar-2021, the patient experienced HEADACHE (vey bad headaches). On an unknown date, the patient experienced DIARRHOEA (uncontrollable diarrhea which lasted for 3 days), PYREXIA (fever 102), FATIGUE (Tired), ARTHRALGIA (joint pain), NAUSEA (nausea) and CHILLS (chills). On 22-Mar-2021, PYREXIA (fever 102), MYALGIA (body aches), FATIGUE (Tired), HEADACHE (vey bad headaches), ARTHRALGIA (joint pain), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, DIARRHOEA (uncontrollable diarrhea which lasted for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.No treatment details were provided.
Right arm is swollen 2 hours post injections. Swollen area is warm to the touch area about 6 inches with rash on right deltoid. Pain in right deltoid, mild fever. Took naproxen for pain. Initial pain first 4 hours 3-4, Overnight pain about 7-8 scale. Mild jaw pain and deltoid pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: en5318), in right arm, on 18Feb2021 as dose 2, single (Lot number: en6203), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: ew0217) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: strawberries" (unspecified if ongoing), notes: Known allergies: strawberries. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient was sicker with rebound covid than ever was with first time around. Anti-viral details: product: COVID 19 Treatment, Treatment start date: 27Jul2022 ,Treatment stop date: 01Aug2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
I accidentally give the covid-19 vaccine (6month old-4yr old dose) patient is 8yr old on his left arm last 10/07/2023 9:50am.  Patient doesn't have any symptoms.
I got shingles about a week after my second Pfizer COVID shot. It first presented as aching/pain in my right leg for about a week, and then several rashes/blistery areas appeared down the back of that leg which hurt in a burning + sharp pins way. I called my insurance's virtual urgent care line and the doctor diagnosed me with shingles and put me on a course of valacyclovir. We discussed possible triggers, but I had no major stressors or illness or anything else that would have caused shingles - so the doctor and I agreed that it was likely triggered by the COVID vaccine. I had chickenpox as a child and have never had shingles before. I'm a couple days into the antivirals but expect it will take a while for this to run its course.
hearing loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around August 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.  The event of hearing loss was determined to be disabling.
VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lightheaded. Pt  fell to the ground, states he has a history of passing out with needles. Small laceration to forehead and small abrasion to nose. Within 10 minutes in observation hall pt states he felt much better. A&Ox3, with slight HA. Pt wife at bedside. Educated on s/s of when to seek medical attention. Ambulated with steady gait. Denies PMH, meds or allergies.  Offered to call EMS to take to hospital, patients wife at bedside stating she feels comfortable taking the pt home. Educated on when to seek medical care if needed.
2month old was given Havrix; accidentally given Havrix instead of Engerix-B; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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 2 month old patient was accidentally given Havrix instead of Engerix-B, which led to inappropriate age at vaccine administration and wrong vaccine administered. No symptoms reported.  The reporter consented to follow up.
Vertigo/nausea a week from first vaccination lasting about 3 hours. Tinnitus after first or second shot still present.
Right thigh swollen, red, and warm around injection site. Erythema extends to about 3 cm diameter.
At the onset of the injection, I experienced a hot flush feeling throughout my body with dizziness. later that night I woke up with a blurred vision, fever, joint pain, headache, neck pain, upper back pain, and a hot to the touch large lump where the injection was given. These symptoms lasted for about 2 days. The blurred vision and joint pain lasted quite a while to completely go away.
Note from 3/25/2021: PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status.  Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA  done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .Patient is a 91 year old female with PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status.  Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA  done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .
Patient stated that she was fine the first day and then saw the development of a circular red patch around the injection site. It is only a touch swollen, but she reported that it does occasionally burn
Fever, chills, fatigue, cough developed, headache,  from 4/12/2021 through current day
FACIAL RASH 15 MIN AFTER VACCINE WERE GIVEN- FACIAL RASH DISAPPEARED IN LESS THAN 30 MIN.
Redness/warmth at injection site 24 hours following injection TYLENOL 325 mg x 2 po for comfort.
Pfizer COVID shots: got COVID; Pfizer COVID shots: got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer COVID shots: got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: just the results that she had COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Prior to the vaccine my pregnancy was progressing along normally with both normal AFI and fetal size. My first dose was given 12/28/20 at 30 weeks 3 days lot #026L20A, my second dose lot # 013L20A was given 1/25/21 at 34w3d. After receiving the vaccine my fetus began to measure small for dates. An ultrasound showed the fetus has dropped in to the low 20% percentile for weight. Then my AFI decreased also. On all recent scans the AFI has been 6, prior to the vaccines all scans indicated more amniotic fluid.
Patient was not able to walk without help, face changed color and looked as if he had a small seizure.  Patient was transported to the ER where a number of tests were done.  All tests came back ok so the ER doctor determined the reaction was from the vaccine.
pt had a positive COVID test on 2/14/22 in a nursing home; only sx were mild sinus drainage; pt in hospice care; passed away in the nursing home
This spontaneous report was received from a registered nurse referring to a 16 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
It was reported that a 30 year old female was vaccinated with Imovax ID on 11/15/1999. On 11/22/1999, the pt reported that she had a swollen lymph node in the left clavicle region of her left arm. There is no further information at this time. From additional information received on 1/27/2000, it was reported the pt developed a tender 1 1/2 cm node left infraclavicular region seven days post first dose of Imovax second Imovax ID on 11/23/1999 and final dose of Imovax ID on 12/6/1999, without any problems. The lymph node was resolved within a week.
RN removed vial of what was thought to be a new box of COVID bivalent vaccines, which was in fact COVID monovalent box in the "COVID Bivalent" bright yellow bin. COVID box was not labeled "Monovalent" as it has been in the past when received from pharmacy, which indicated to RN that it was the bivalent, as it was also placed in the bivalent bin. RN pulled up all 6 doses up, and put them in the appropriate area for MA distribution. All COVID doses were distributed to patients. Different RN was notified that the clinic needed more bivalent doses, and went to the fridge to grab a vial of COVID bivalent vaccine to pull for distribution. Once at her desk, nurse noticed that the vial stated "COVID Vaccine", Not "COVID Bivalent". RN went back to verify that the box was also monovalent placed in the wrong bin. RN discussed with  RN that it might have been monovalent distributed, RN confirmed that the vial used this morning for vaccines was pulled from the monovalent box that was labeled without "monovalent" and put in the COVID Bivalent bin.  RN and RN went to nursing supervisor to report the incident. Was onsite who was the previous Nurse Supervisor. Contacted IT in pharmacy to obtain a list of the patient's administered vaccines today. List retrieved. RN notified patients on 1/19 Per MD infectious disease head, 2 months until patients can receive bivalent dose.
Patient presented to ED on 9/6/21 with severe shortness of breath. Patient was previously diagnosed with COVID 1 week prior. Previously vaccinated with J&J on 6/22/21. Admitted for pneumonia due to COVID on  9/6/21 and discharged 9/16/21.
3/19/08:  Mother of client spoke via phone reporting infant developed onset of hives beginning approx @ 1:00 pm.  Hives localized to shoulders & associated with redness.  Advised to contact primary care provider.  3/20/08:  Follow up phone call to client's grandmother by RN.  Reports hives & redness lasted approx 2 hrs and infant now asymptomatic.
On 06/13/2022, I went to bed with a horrible splitting headache. When I woke up the next day, I felt incredibly bad. It felt like a bad flu. I called a local urgent care clinic who prescribed Paxlovid and some cough medicine because I had a horrible cough at the time. I tested myself for COVID-19 with an at home test and it was positive. After receiving the prescriptions, things slowly got better, but for the first few days, my symptoms were really bad.
patient developed occipital headache, backache, flushed sensation, and weakness; has known history of "MS".  pt. given a water, vitals signs taken, and 1st response team called to transport to ED.