chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAY-2018, the patient was inadvertently vaccinated with the third dose of PROQUAD recombinant Human albumin (rHA) lot # N029156 with expiration date 16-APR-2019, intramuscularly, for prophylaxis. No adverse effect was reported. It was stated that the patient received previous doses in 2006 and in 2009.
No additional adverse events reported.; Physician reports the administration of a larger dose of VARIVAX to a 13 month old patient.; This spontaneous report was received from a physician and refers to a 13 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 mL, lot # T032319, expiration date was not reported but upon internal validation was established as 22-SEP-2022 (route of administration and anatomical location were not provided) for prophylaxis; the administered dose was larger than the patient should receive (incorrect dose administered). No adverse events were reported.  The physician asked for safety and viability information regarding the administered dose of the vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Provider ordered Pfizer Biontech 30 mcg/0.3 ml Covid 19 vaccine for patient 17 year old male. Nurse LPN prepared vaccine (She had inquired earlier for clarification on dilution for the Pfizer as she doesn't mix it typically, She was advised 1.8 ml for regular Pfizer. Inadvertently mixed a Peds dose Pfizer vial formulated for 5-11 year olds. It was discovered before parent left as staff notice a vial of the Ped dose was open and she knew we were not yet using that vaccine. The only Peds doctor working at that time was Dr so she checked with provider to see if he had indeed ordered a Ped dose for someone. He said he did not, then stated he just ordered a regular Pfizer for a client. We then check with the nurse and inquired what vaccine vial was used to give the Pfizer she just had gave and where which container did she give it from. It was indeed the Ped dose. Dr. spoke with patient and parent. It was then decided that an additional dose of the Ped Pfizer vaccine would be given @ 0.2 ml It was discussed to check for possible additional information and deemed by provider to proceed ( A new separate vial was open and mixed as it was unknown at that particular time to which degree the previous vial was diluted) The additional dose was administered at 0.2 ml as requested by provider. The information for the additional dose was documented in the original order with explanation of what was given. Provider had stated there wasn't a separate order available at that time. Patient was held for an additional 15 minutes had no issues or complaints and released with parent. When the Pfizer Ped dosage was received the previous week, the vaccine coordinator, staff placed it in the Main fridge on a separate shelf from the regular Pfizer. It was kept in its original box and placed in a plastic bag marked as Ped Pfizer 5-11 years and was then tagged with a sticker as a visual method to make it stand out as different. It was also placed in a Blue bin marked with a sticker. The blue bin was also marked as Pfizer Ped 5-11 only, dosage 0.2 ml and the Diluent amount all written on bin. Regular Pfizer has always been kept in a green bin on the middle shelf of the unit. After intendent the Blue bin was removed from Main fridge and was relocated to the other fridge with a Note on it stating do not use. I also added two additional stickers 1 High Alert and 1 Look alike Sound alike stickers were placed on both Pfizer vaccine bins although now in different units I thought it maybe helpful being as proactive additional prevention till asses by those who investigate such matters as to what best method for storage should be. It was reported to nursing supervisor as well.
ACHES; FEVER; FATIGUE; HEADACHES; 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 was not reported, administered on MAY-2021 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 subject experienced aches, fever, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue, aches and headaches was not reported. This report was non-serious.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 17-Nov-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No Treatment information was reported.
101.5° fever, chills, severe headache, severe joint pain, nausea, fatigue
Flare up of Lichen Planus on back, scalp, eyelash follicles, and vulva.
GBS reported in pt who recvd flu vax & 10 days p/flu shot pt was hospitalized for rapid progression of weakness; CT scan suggested surgical etiology for GBS; pt still exp muscle spasms;
Sore tight muscles in arms and legs/ hard to get on/off toilet, hard to get up from sitting position; Sore tight muscles in arms and legs/hard to get on/off toilet, hard to get up from sitting position; Hard to walk, stopped taking stairs/ Hard to get on/off toilet, hard to get up from sitting position; Some days temperature will spike to 102; Cold chills; Hives; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration on 24Feb2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, allergy to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both from an unknown date for an unknown indication. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and cefdinir (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced sore tight muscles in arms and legs, hard to get on/off toilet, hard to get up from sitting position, hard to walk, stopped taking stairs, some days temperature will spike to 102, sometimes got cold chills and have to get under 3-4 throws and sometimes have hives. It was reported that doctor did blood work which looked good and thought symptoms related to shot. It was reported that the patient had shot 9 weeks ago, at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with famotidine/ibuprofen (DUEXIS) 800 mg 3times a day. On an unknown date in 2021, the patient underwent body temperature test and the result was 102 (unspecified units) and also underwent blood test and the result looked good. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore tight muscles in arms and legs/ hard to get on/off toilet, hard to get up from sitting position, hard to walk, some days temperature will spike to 102, cold chills and hives were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/20/2022 Discharge Date: Jul 2, 2022  PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] AKI (acute kidney injury) [N17.9] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 75 y.o. female with past medical history of recurrent DVTs on Eliquis, Alzheimer's dementia, schizophrenia, insulin-dependent diabetes mellitus type 2, and chronic pain on tramadol who presented for generalized weakness and frequent falls. She was subsequently diagnosed with COVID-19 pneumonia with respiratory failure. CXR consistent with COVID-19. She was started on decadron and remdesivir. She was seen by PT/OT who recommended SAR. She developed new onset atrial fibrillation and was already on Eliquis. Echocardiogram showed normal LV function without valvular pathology and a normal sized IVC. Eliquis was increased to 5mg twice daily and metoprolol was added for rate control.  She was weaned from oxygen.  She completed her course of decadron and Remdesivir during admission. Insulin adjusted due to steroid induced hyperglycemia. She was discharged to subacute rehab in stable condition.
I developed Shingles in the left arm and experienced very painful swelling. It had the appearance of chickens pox on the upper left arm and the pain kept me awake at night. I had a doctors appt next week was prescribed Valacyclovir on February 28, 2022 to treat Shingles. However couldn't take the full dosage I got COVID after Dose 3.
runny nose; This is a spontaneous report from a contactable other hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The Patient Medical history included, surgeries in January from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. The patient previously took xeljanz xr in the past and it stopped working. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. The Patient has been off treatment as she had surgeries in January and had both COVID-19 vaccines while off Xeljanz. On Unspecified date, the patient experienced runny nose. She is having anxiety because her son is being deployed in a month. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HIB administered after expiration date. Vaccine expired Nov 19, 2017 and was administered to pt Nov 21, 2017. MA that administered vaccine mistakenly read expiration date as Nov 17, 2019 as the manufacturer had date written on box as 19NOV17. Manufacturer was contacted, per CDC recommendation, vaccine will be re-administered. Provider has been made aware and will be contacting mother of the pt today to discuss. Discussed with MA who administered vaccine. I have seen this same error at 2 other facilities I have worked at outside of this company. ***There was no reaction to the vaccine.***
Within few hrs after IZ: Fever - 103 degrees, checked by thermometer - took TYLENOL --> Temp decrease to 100 degrees F by 10:45AM (phone call from client) 4-21-10 "bad headache" - not relieved by TYLENOL on 4-21 --> took Ibuprofen 4-21 with relief. Achiness "all over" and fatigue, although slept well from 4PM 4/20 til 4/21AM.
Pt recvd vax 1-2 days later exp nausea, vomiting, jaundice, anorexia, abdo pain;
This spontaneous report as received from a nurse refers to a 11 year old patient who in approximately December 2013 (within the last month or two), was vaccinated with the first dose of GARDASIL dose 1 (dose, route and lot number was not provided). The reporter informed that the patient experienced that they "felt funny" and then had a seizure, after receiving the "eleven year old shots" which included the first dose of GARDASIL, "within the last month or two." The patient urinated upon himself, during the seizure. The patient was sent to the hospital, as per the office protocol. The patient did not require intervention to prevent serious criteria. At the time of the report the patient was well. No further information was provided. The outcome of had a seizure, after receiving their first dose of GARDASIL, urinated upon himself, during the seizure and "felt funny" was unknown. Upon internal review, the event of seizure was considered as medically significant. The relationship between adverse events and GARDASIL was unknown. This is one of two reports from the same source. Additional information has been requested.
After receiving the vaccine I felt nauseas and I had a fever on May 5, 2022. I had a fever of 100.5 degrees and a cough. I felt a little better on Friday, May 6th, but I still felt a little sick just not as nauseas. The fever went away and then I flew. Then on May 18th I had a voluntary outpatient surgery to remove my fallopian tubes. It was preventive to prevent ovarian cancer. I do not have cancer. On May 19th my lingering cough got worse. Post surgery I started feeling bad. I developed a much worse cough and I started to feel very poorly and out of breath. When I called the surgery doctor she said to get a Covid test. I took the at home Covid test and it was negative. I went out on Tuesday and got a rapid and PCR Covid test did. They were both negative. In that time I was feeling very poorly until I called my internist. That doctor suggested I get a chest x-ray. My heart rate was 42 BPM when I checked it. I called my doctor and they told me to go to the ER which I did. In the ER they discovered that I have second degree AV block with 2 to 1 conduction. That's an electrical system heart problem that requires a pace maker to regulate my heartbeat for the rest of my life. I was admitted into the hospital and they decided to order a cardiac MRI. When the results came back from the MRI it showed I have myocarditis. That was causing me to have the AV block. They have run every infectious disease that could cause myocarditis, but everything so far that has come back negative with an exception of a few coming back with outstanding results. I have been working with a good infectious disease  doctor who is well known. That doctor believes that the vaccine caused me to have myocarditis. I have had 2 infusions of IVIG for 2 days in a row. Today they are going to start me on steroids to reduce the inflammation.
Bilateral leg swelling - still persists in lower leg, foot and ankle - muscle and joint pain- both swelling and pain continues until now
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; CHEST IS HEAVY; This spontaneous report received from a patient concerned a 55 year old female. Initial information was processed along with the additional information received on 05-JAN-2022 and 10-JAN-2022. 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 (dose number in series 1) (suspension for injection, route of admin, and batch number:1808982, expiry: Unknown) dose was not reported,1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination.  The patient received non-company suspect vaccine included: MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose not reported, administered on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  On 26-DEC-2021, the patient experienced itchy throat, shortness of breath (subsumed under confirmed covid-19 infection) and felt like chest was heavy. On 27-DEC-2021, she did Covid-19 test by going to a testing center (unsure of PCR/antigen test). On 29-DEC-2021, the result received as Covid-19 positive, hence confirmed clinical vaccination failure (dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and, MRNA 1273 was not reported. The patient was recovering from confirmed covid-19 infection, and chest is heavy, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220104857. This report was associated with product quality complaint: 90000210194. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220104898-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Within 8 days the patient began having dyspnea upon exertion. Mild fever within 24 hours of booster. Ectopic beats reported. These are all new and temporal to booster.
patient experienced a syncopal episode about 15-20 minutes after receiving vaccine but did not seem to lose any consciousness, just fell to the floor; family members helped to brace his fall a little but think he did hit his head. EMS was  called and blood pressure and blood sugar were checked and normal. Patient was anxious prior to vaccine and may not have eaten much prior to appointment. Family opted to have him taken to the hospital to be checked out just to be safe.
Symptoms appeared apprx. 3 hrs. after receiving shot.  Throat closed up, difficulty breathing - felt like asthma, light headed - dizzy, secretion from eyes and cough.  Later in the day and into the next day, achy all over, eye secretion continued, cough.
Days 1-2 after the vaccine, standard symptoms occurred like groggines, cloudiness, body aches, mild fever, soreness at injection site. These symptoms were very mild or gone after day 2, but on day 3, I developed a painful reddish bump the size of a pea in my armpit opposite the arm where the injection was. Injection was in left arm, painful bump was in right armpit. It hurts (7-8/10 pain) to lift my arm or really move my arm and still hurts somewhat when my arm is just resting. Day 4 after the vaccine, I had a second very small red bump and noticed some other puffiness in a different spot in my armpit. This did not have color variation from my skin. It has hurt enough that I am not able to apply deoderant or really use my arm for daily tasks. I am currently in Day 5 after my vaccine has stayed pretty consistent with Day 4. No new bumps, but similar pain and swelling. Pain seems to reduce minimally when taking ibuprofen. I also had a headache on Day 5.
Patient developed fever to 103.7 (route unknown) and headache on the evening after receiving this vaccine. Fever resolved after 36 hours. Pt vomited on 1/7 (day before vaccine), 1/8 and 1/10.  Headache improved with OTC acetaminophen and ibuprofen
Patient went to sleep in the car on the drive home from physician's office. Her breath during sleep became extremely slow and shallow, worrying her mother that she would stop breathing. Mother tried to wake patient by saying her name, speaking loudly, and clapping her hands. Patient opened her eyes after approximately two minutes of attempts to wake her, but continued to appear extremely lethargic. Upon arrival home, the patient appeared alert and happy for 30 minutes, then fell asleep again. During this sleep her breath became very slow and shallow yet again, so parents stayed next to her to watch for additional symptoms while she slept. After three hours of deep sleep, patient awoke but acted lethargic for the rest of the evening. Was normal the following day and no additional treatment was needed.
Pt. stated she received her flu vaccine at 1:37 on October 7, 2022. She has received the flu vaccine many years and denies ever having a reactions. Appr 30 minutes later pt. states she developed a rash on parts of her body and face and felt flush. She was advised to take Benadryl but wanted to get home first. On her way home she stopped at clinic, was initially adminstered a shot of Benadryl and oral prednisone. Twenty minutes later she was still have difficulty breathing and was administered an epipen. At discharge from clinic, a family member drove her to ER. Pt. states that when she arrived at ER she had elevated BP and her oxygen saturation was 88% which increased quickly. It was determined that she did not have an obstructed airway. Pt. states she received am additional epipen and an IV (she believes was steroids). After being monitored for 4 plus hours she was sent home with 2 days of oral prednisone, oral benadryl and an epipen.  * Saturday, October 8, was uneventful. Pt. stated she took Benadryl in am and the prednisone as directed. She had no signs of a reaction.  *Sunday, October 9, she woke with systemic hives/ Difficulty breathing and talking increased as the day went on. She did not have the epipen with her so returned to the ER. She received another dose of epinephrine, IV steroids and was monitored for 4 hours. She was given a 5 day course of prednisone 200mg, 2 tablets daily.  * Monday 10/10 - she is taking oral Benadryl and is planning on filling the prescription for prednisone.   20 Patient denies having hives, rash, or any respiratory distress on Monday 10/10. Has follow up appointments scheduled with primary care and allergist.    22. Additional Information: Patient denies any vaccinations, medications, or illness in the past month