chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination failure; COVID symptoms started on 12Jan22 and tested positive on 13Jan22; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EN6203) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 25Feb2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jan2022, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 12Jan2022, outcome "unknown", described as "COVID symptoms started on 12Jan22 and tested positive on 13Jan22". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No known allergies and no other medical history. COVID test post vaccination: COVID test type post vaccination was other, COVID test name post vaccination was saliva, COVID test date was 12Jan2022, COVID test result was positive.
This is a spontaneous report received via medical information from a contactable consumer (patient's spouse). A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 59-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced shingles and kidney function is impaired. The clinical course of events was as follows: The patient received the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and was diagnosed with shingles 3 days later (10Apr2021). The reporter stated that  the patient's kidney function is impaired when the doctor ran lipid panels (unknown results) and urine panels in which the patient had "strange, high readings" on 10Apr2021 with her BUN was 26 (High), referencing at 24; creatinine level was 1.54 mg (High), referencing 1.00 mg; GFR (glomerular filtration rate) filtration rate was 37 ml/second (abnormal), referencing at >59 ml/second. The reporter stated she received more testing on 28Apr2021, in which the lab values had improved, but have not returned to her baseline on 28Apr2021 with her GFR was 64 ml/second (normal) and creatinine was 0.97 mg/deciliter (borderline). The reporter stated her GFR in November(2020) was 96 ml/second (Normal) and her lab values were all within normal range at her last doctor's appointment on 01Dec2020. The reporter states the only thing that has changed in her regimen was receiving the Covid-19 vaccine. He is concerned if his wife will make a full recovery and if her kidneys are damaged due to the vaccine. The patient has not fully recovered from shingles and still has aches, pains, and skin lesions that have not fully disappeared. He was also asking if she needs to recover fully before receiving the second dose. The clinical outcomes of the event "kidney is impaired" was resolving while the event "shingles" was not resolved.
Information has been received from a physician concerning a 7 year old male who on 12/14/1998 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccine administered on the same day included a first dose in the left arm of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 624667/0068H). The patient presented on 5/18/2005 with breakthrough varicella, with less than 50 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a woman working in a physicians office indicated that she could not recall the identity of the patient. Additional information is not expected.
Nurse inadvertently administered extra dose of Covid vaccine after it was originally administered 10/6/23. The vaccine had flagged as due in the eHR, and the patient was asked if he wanted and agreed to have the Covid vaccination.   The patient tolerated the procedure well, and there was no adverse reaction. The patient was informed of the error, and advised that there is no data suggesting that this would be harmful, and that if he has any symptoms to report to urgent care.   This was a pediatric dose.
Large area of induration with erythema, covering most of upper arm.  Had previous reaction fall 98, treated for cellulitis with Keflex.
10 days after I received the vaccine, I began experiencing leg pain in both legs.  I first experienced what felt like muscle cramps and they progressively got worse throughout the day and week.  I also began experiencing what feels like pins and needles on the back of my legs from my upper thighs, calves and into my ankles at times.  The pain continued so I went to my doctor 3 days after first symptoms appeared.  I also began my menstrual cycle 3 days after the onset of the leg pain and had a tremendous amount of pain (cramps and sharp knife like pains) in my abdomen and pelvis for 3 days during my menstrual cycle.  I also discussed this with my doctor.  While pain and cramps are typical with my periods, this was nothing like I have experienced before.  I also passed many clots both small and large (larger than a 50 cent piece) the entirety of my menstrual cycle.  While a few clots are normal for me, the amount I was passing the entire time has never happened to me before.  I am still experiencing the leg pain and pins and needles sensations in my calves.  I also have experienced weakness in my left arm from time to time since receiving the vaccine.
BLURRED VISION; TROUBLE BREATHING; This spontaneous report received from a patient concerned a 73 year old female. Initial information was processed along with additional information on 19-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer, and breast cancer. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212D21A, and expiry: UNKNOWN) dose was not reported,1 total, administered on 12-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-DEC-2021, after the patient received booster, she experienced blurred vision. The patient had seen her health care professional (HCP) for blurred vision and the doctor prescribed her eye drops to relieve blurry vision but the blurred vision was not resolving. The patient did not know the name of eye-drops and could not read the name of the medication. On an unspecified date in DEC-2021, patient experienced trouble breathing but she does not believe that it was caused by the booster (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, and the outcome of trouble breathing was not reported. This report was non-serious.
Mom states the infant was screaming and crying with a high pitch cry and shaking. Pt was taken to ER. PT had a temp of 98.7. Diagnosis was hematoma on right thigh and possible allergic reaction.
This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's concurrent conditions included an allergy to a compound in amoxicillin, AUGMENTIN and doxycycline. On 29-OCT-2015, the patient was vaccinated with PNEUMOVAX 23. Concomitant therapies included atorvastatin (manufacturer unknown) and SYNTHROID. On the date that she received the dose, the patient experienced injection site induration, injection site swelling and injection site pain. The reporter also stated that "I could barely move my arm; my arm was stiff" so she left work early that day. Later, on the same date during the evening, she began to experience fatigue and malaise. During the night of 29-OCT-2015 and 30-OCT-2015, she began to have fever of 99.9F. She sought medical attention at an urgent care clinic on 30-OCT-2015. The healthcare provider at the clinic recommended her to use ice on the injection site and to take BENADRYL. The patient stated she did not like BENADRYL because it made her sleep. The following date, on 31-OCT-2015, she was instructed to use heat on her injection site. The outcome of the events was reported as recovering. Additional information has been requested.
Patient was injected an unknown amount of covid (moderna) vaccine, the patient is concerned if she has protection from covid now.
Patient visited pharmacy on 9-20-17 stating she received flu shot on 9-17-17 and her left arm was slightly red underneath where shot was given. She said it had been previously a little inflamed but redness was improving. She states it was slightly sore but hasn't taking any medications. Patient will monitor.
tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine)     Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic or long-standing health condition. It was unknown that patient had prescriptions, over the counter medications, dietary supplements, or herbal remedies  which was being taken at time of vaccination and/ or at the time of the adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021 at 8:59 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.      Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Live follow-up received included no significant information.
Approximately 14-16 hours after the second Shingrix shot, I got hot, dizzy, and weak, my throat tightened, and I felt short of breath to the point of almost passing out. At the time I was riding a chair lift at a Ski Area at approximately 12,000 feet. As I unloaded I did not see emergency or ski area personnel. Since I normally do not have asthma symptoms of any kind, my rescue inhaler was in my car. I made my way barely to the car, used the inhaler, and drank a cup of an energy drink in lieu of using an epipen. I did not feel well enough to hike to ski area first aid office, and I waited to see if I should call 911. After about an hour I was somewhat better and drove home carefully. After about a day I felt better. I did not report the event to my physician or pharmacy at that time since I felt better. However, I did mention this event to my doctor's Physician Assistant on October 7 while discussing Covid treatment options, including monoclonal antibody infusion/shot. Preceding this, I had my first Shingrix shot on 10/8/20. Within a few hours I felt dizzy, weak, and terrible, akin to the flu. I had not reported that to my physician or pharmacy since the symptoms cleared a day or two later. Since then, I have been concerned about my body's future reaction to shots of any kind.
The spot where I got the vaccine is now yellow and blueish; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish). At the time of the report, VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
High fever, up/down fever for 48 hours.  Small tiny mark no redness or swelling at site.
Side effects after 2nd shot (reporter mom); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after 2nd shot (reporter mom)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 COMPLICATION (Side effects after 2nd shot (reporter mom)). At the time of the report, VACCINATION COMPLICATION (Side effects after 2nd shot (reporter mom)) outcome was unknown.            No treatment was reported. No concomitant medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
pt. was given high dose flu vaccine in left arm. It immediately started to swell. Dr. notified Ice applied. Swelling was improving by end of appointment. No other symptoms. Pt was given flu vaccine LD SITE Immediately started to swell. Dr was notified. Ice applied. Pt had no other symptoms. Pt swelling improved throughout her appointment swelling showed noticeable improvement in the 45 minutes of giving vaccine.
Adacel has been administered after temperature excursion, were exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working/No AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA317553 (same reporter).  This case involves male patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] after temperature excursion.  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 dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5666AA, expiry date- 19-04-2021 via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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 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.
Patient was given TDAP vaccine in left arm. Upon administering vaccine, patient stated he was feeling lightheaded. I asked him if he was dizzy, he responded yes. I told him we could wait for a few minutes before administering next vaccine (patient was to get HPV as well). Few seconds later, patient was slouching over in chair, shaking. Patient's grandmother was with him and ran to assist to try to help lay patient down. I put an ice pack on patient's head, he began to awaken a few seconds later. We provided patient cold water/gatorade. Patient was alert, awake, and oriented at this point. I sat with patient for approximately 10 more minutes before he stated he felt completely normal and walked out of the store with his grandmother.
This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 42 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, a patient reported to her today (2nd August 2018) that she had a shingles outbreak 6 weeks after receiving the vaccine. The patient reported to her doctor after she had 2 spots, which was confirmed to be shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of vaccination schedule and laboratory confirmation for shingles were unknown. The pharmacist was unable to provide any additional information and appeared to be in a hurry, but stated that she would call back if she obtained new information. Service request number provided to her.
a SECOND DOSE OF FLU VACCINE WAS GIVEN IN RIGHT ARM INSTEAD OF HEP A VACCINE. AFTER THE DISCREPANCY WAS DISCOVERED, HEP A VACCINE WAS GIVEN.
Pt called today (6/14/21) to report "nodules" on body. Did not specify where. I explained the added risk for blood clots to the patient with administration of the Janssen (JNJ) Covid vaccine. She does not believe they are blood clots.I directed her to contact her physician immediately to notify of the adverse event as well as utilize v-safe and VAERS. Other than reported "nodules" pt is feeling fine.
A FEW DROPS OF VACCINE CAME  OUT OF THE SYRINGE ONTO THE  PATIENT'S ARM; UNDER DOSE; This spontaneous report received from a consumer concerned a female of unspecified age. 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. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced a few drops of vaccine came out of the syringe onto the subject's arm, and under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a few drops of vaccine came out of the syringe onto the patient's arm and under dose was not reported. This report was non-serious.
MUSCLE ACHES AND FATIGUE WITHIN 8 HOURS OF RECEIVING VACCINE. LOW GRADE FEVER 99.5-100.4 BETWEEN 1AM AND 8AM 3/30. EXTREME FATIGUE, BLOATING AND CLOUDINESS 24 HOURS +.
Pt had fainting within 5 minutes after the shots and fell down. Vomitted x1. VSS nl. Received a dose of epinephrine sc .3cc
After the initial, expected, local reaction healed, the same local pain returned a couple of weeks later.  At first the pain was intermittent, aching pain at the injection site.  Eventually the pain became almost continuous.  It felt as if I was constantly receiving the injection.  Within approximately 12 weeks, my shoulder was frozen.  I went to see my PCP on 1/11/13, had an MRI on 1/23/13, and seen by an orthopedic surgeon on 1/27/13.  I underwent 2 months of physical therapy to regain the range of motion in my arm.  I am no longer receiving PT but, still do not have complete ROM that I had before the flu intrademal injection.  The constant pain at the injection site seems to be resolved but the shoulder still is not back to normal.  I still have to continue using the exercises I learned from the physical therapists to keep my shoulder flexible.
Chills; Fever; Flu like symptoms; This case was reported by a pharmacist via sales rep and described the occurrence of chills in an unspecified  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, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the chills, fever and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that about 3 or 4 patients reported chills, fever, and flu like symptoms after receiving vaccine. Next day they were fine. The reporter discussed potential of if patient got flu shot, patient did not remember. The reporter consented to follow up.
Localized rash (hives) at injection site on DAY 8 after vaccination.  3x6cm around injection site.
After receiving the vaccine I started to feel heavy in my chest. It felt like the same feeling I get when I have an asthma attack. I thought it wasn't that bad and that I would be okay. I was just coughing a little bit. I didn't think I should tell somebody. As I was walking back to the car it was getting hard to breath. I was about 300 yards from the clinic. I was coughing so hard that I started throwing up. Most of it was just mucus. I used my Ventolin inhaler and stopped to see if that would work. Me and my son opted to stay there close to the clinic and wait. My inhaler started to work and I could breath again.
pt admitted to hospital one day after discharge from local Medical Center with COVID pneumonia; taking oral antibiotics; labored breathing, agitation/delirium; admitted with O2 via NC; hx of AKI, DMT2, CAD, dementia; beyond the window for remdesivir; palliative care initiated; pt's condition worsened and he expired in the hospital
Employee received vaccine in left arm, two days later he had a lot of pain, swelling and was unable to lift arm above shoulder level.