chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, doses of ROTATEQ (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experience had been reported. This is one of several reports received from same reporter. Additional information has been requested.
This infant's parent reported persistent crying lasting ten hours. The parent reported the infant would only be consoled when her mother was holding her. The parent reported fussy behavior, vomiting 2 or 3 times, fever (temp under 105 F). The parent called the doctors office. The parent treated the fever with acetaminophen.
I have not experienced more then a day of very light spotting during my menstrual cycle since 10/2018- months after my iud was placed.  Days after my first Pfizer Vaccination I began to have menstrual bleeding that remained consistent until December then tapered off.  I still have about 1.5 weeks of bleeding every week which is still significantly more then prior to the vaccination.   I also developed a golf ball sized knot in my left armpit (same arm as injection) that remained for approx 3 months and eventually went away with massage, hydration and lymph flushing.  I still have spontaneous pain from my left arm pit forwards my left center breast.
I developed a decent case of tinnitus in my left ear today.  I?ve had it before?likely due to my TMJ but this is pretty annoying.  It?s been nonstop for about 7 hours.  Could be a coincidence but thought I should report.
Positive Covid test on 01Sep2021; Positive Covid test on 01Sep2021; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 39-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8735, via intramuscular route of administration on 22Apr2021 (at the age of 39-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Benign heart murmur. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. The patient previously took Demerol and experienced known allergy. On 01Sep2021, the patient experienced positive covid test. No seriousness criteria were reported. No treatment received for AE. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Sep2021. No other vaccine received in four weeks. No covid prior vaccination, it was unknown if covid tested post vaccination. The outcomes of event was recovering
First I have not suffered any injury since getting the vaccine.Arm and shoulder area has increased in pain until heat was applied on March 10, 2021. Next day pain was increased and range of motion declined. By Friday, March 12th I could not raise arm more than 6 inches. Went to the Dr. on 3/12/21 and was referred to the Orthopaedics. Saw PA on 3/12/21. Xrays were taken I believe the diagnosis is in part subacromial bursitis.. Received Cortisone shot. Range of motion was much improved and has stayed about the same through today. Iced shoulder last night because of mild pain. Woke up in considerable pain which has continued today. I have iced the shoulder and upper arm at other times also since 3/10/21.
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 9 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Pins and needles started in my legs approx 1 week after vaccine Since then over the second week, they have progressed to my upper body, arms, legs and face I have also experienced burning sensations and numbness in my feet and legs Both pinkies are number and tingling most of the time
Chronic Spontaneous Urticaria: raised redness and itchy hives spontaneously appear in patches on various parts of the body - generally worse at night and in the morning. But pretty constant all day. Treating with antihistamines.
About 15 minutes after receiving the vaccine, my face turned bright red and I had a rash on my upper chest. Then hives appeared on my face and upper chest as well. I did not experience any pain or respiratory symptoms.
This spontaneous report as received from a healthcare professional refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL injection (lot # K011562, expiration date 08-PAR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Caller clarifies that she still has long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, 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. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: Had COVID in 2020 prior to the COVID vaccines; was hospitalized for Covid virus. The patient's concomitant medications were not reported.  The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Caller clarifies that she still has long Covid".  Additional information: Caller states she also has long COVID. Had COVID in 2020 prior to the COVID vaccines; was hospitalized for COVID virus. Caller clarifies that she still has long COVID; but she has different symptoms than her husband. Neurological. She also had Moderna COVID vaccine primary doses; two Moderna COVID boosters; and her third booster was Pfizer COVID booster. Reporter details: Reporter type: documented as Consumer; She mentions that she was a home health aide and a dental assistant in the past; specifically calling about herself.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300066918 Same patient/vaccine, different dose/event;
pt is here to receive 2nd dose of Moderna vacc. & she stated 1st dose caused some soreness to  the arm & slight fatigue but she noticed blood upon urination after 1st dose on that afternoon. It was not bright red blood but was dark/brick red color like menstrual  break through bleeding she did not notice pain associated with it . She did not notice any more vaginal bleeding after the incident. She reported to her PMI, & PMP OK'ed for her to get 2nd dose but to call him if the same urination occurs @ 2nd dose pt abn on Estradiol(HRT)
A nodule developed in my left palm approximately 2 weeks after first vaccine. The condition became more evident and extensive within days after my second dose. Dupuytren?s Disease was diagnosed by a hand surgeon on 3/31/2021. I have no risk factors or family history for this disease. No treatment was recommended at this time; just observe progression of disease.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. patient had previously received a COVID-19 Vaccine.  There was no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: continued to test positive for COVID-19 on 9th day after starting Paxlovid; (03Aug2022) Positive, notes: Also tested positive on 11th day after starting. Therapeutic measures were taken as a result of covid-19. COVID-19 Treatment of Paxlovid started from 23Jul2022 to 28Jul2022   No follow-up attempts are possible. No further information is expected
Instant sender headache lasting 4 days,  extreme high blood sugar, fatigue, tender left underarm lymph nodes, brain fog for 5 days
I feel like my muscle or bone is very weak, it's like my arm doesn't work in full capacity anymore. I've adjusted to it its been since January. I work in a nursing home and have to lift things and I don't have the strength that I once had. Feels like deterioration in my muscle or my bone or something.
Within the first 20 minutes I had light headedness and shortness of breath and I had to breathe hard and make myself gasp. It was really mild. The next day I had severe light headedness with a lot of pressure along with a migraine and severe heart palpitations, ear ringing. The headache lasted for 3 days and head pressure continued for about 11 days. The pressure was present without the pain of the headaches. The dizziness lasted about 9 days as well. The heart palpitations have not stopped. I never experienced the common side effects such as body ache, fever, chills. I ended up in ER from these things but first had phone appts where they ordered EKG, blood tests. I was going to dermatology and then going to a breast surgeon to get a boil cut and drained but that never happened because my blood pressure was so low that she sent me to the ER because I was light headed and strong heart palpitations. They gave me two IV's to bring blood pressure up and it did. I went home after about 5 hours. Day one and Day two I also had chest pains like in the heart area only on the left side that started the evening of the 31st. As of last night 09/12/2021 I'm experiencing the pain in heart area again and the heart palpitations have calmed down during the day time but do come back at night when I'm resting, and they last for about 6-9 minutes. I have appointment tomorrow with a doctor. EKG showed low beats per minutes but there was no concern.
devel focal sz activity 1-2 hrs following vax w/DTP/OPV; twitching or rt side (arm & leg); no emesis, cyanosis; cont intermittently on 9JUN; was given Ativan;
Patient reported a raised, hard, hot lump approx. 2cm raised by 4cm wide.
I received my second shot of the BioNTech, Pfizer COVID-19 vaccine on November 19th, 2021. Initially, did not have any symptoms other than soreness in the area where the injection was administered and I felt fine. But that night I woke up with a burning fever (102.2), my whole body was aching to the point where even the pores in my skin were hurting; despite the high fever, I felt terribly cold and shivery. I took one Tylenol and tried to go back to bed. By 10-11 am the next morning, my temperature had gone down to 101 but I still felt incredibly weak and cold, could barely mange to lift the frying pan or pour water out of the jug. I took another Tylenol around noon on November 20 with food. Couldn't taste the food either so it was hard to eat. Took more Tylenol at 6-8 hour intervals and by Sunday afternoon (today), my temperature returned to normal. Still feeling horribly weak and achey.
Temp 103.6 throughout Friday night with violent rigor, extreme chills, extreme body aches, bed ridden fatigue. Temp again Saturday 102.7 with less violent rigor, chills, body ache,, nausea, abdominal cramps still bed ridden. Temp low grade Sunday excessive diaphoresis not able to participate in daily activities. Monday fatigue but able to perform daily activities. No temp, mild diaphoresis.
Case number PHEH2013US007936 is an initial spontaneous report from the pharmacist received on 05 Apr 2013. This report refers to a 20-year-old female patient. She was vaccinated with an expired MENVEO (batch number: M10053) intramuscularly on 05 Apr 2013. It was reported that, no adverse reactions have occurred since this administration. No other information was available.
DID NOT BE COMPLETE DOSES PRIOR TO TRAVEL; TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-764) was received from a consumer on 29-Mar-2019. It describes a 44-year-old adult female consumer who "took unrefrigerated doses" and "did not be complete doses prior to travel", while being on oral Vivotif (one dose every other day) for typhoid prophylaxis.   Case report: The consumer did not refrigerate Vivotif doses and took the first dose on 25-Mar-2019. She was scheduled to take her third dose on 29-Mar-2019. She will be leaving for a 7-day trip on 30-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the events "took unrefrigerated doses" and "did not be complete doses prior to travel" was unknown.  Company's Comment: The causality of the events "took unrefrigerated doses" and "did not complete the full course one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took unrefrigerated doses" and "did not complete the full course one week prior to travel" was considered as not applicable.
Red circular area around injection point, itching, warm to touch, slightly swollen. Reactions lasted off and on for almost two weeks.
It began is eye blinking, then turned to facial tics, and now includes the whole head jerking and shoulders moving.  There were NO prior signs of ANY prior tics in my child.
After receiving the immunization, she began to get a sore arm later that night.  The next day, she had redness and swelling around the injection site.  The redness and pain kept spreading and has since reached her elbow and gone around her arm.  She saw and urgent care over the weekend, but was only told to take benadryl and use ice.  It has since gotten worse.  She said she would call the urgent care back.  That is all we have currently heard about the issue.
Headache, Myalgia, CoughWheeze, Chills, Fatigue, Congestion Narrative:
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 48-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 10:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:41 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.59 for dose administered on 27-MAR-2021 and 48.51 for dose administered on 27-FEB-2021.   No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion 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 at 09:00 AM, 35 degrees Fahrenheit from 11:00 AM to 02:00 PM, 34 degrees Fahrenheit from 03:00 PM to 04:00 PM and 35 degrees Fahrenheit at 05:00 PM. 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.
Patient reported in March 2019 that she was unknowingly 10-12 weeks pregnant at the time of vaccination.
Mom described a 10 second episode where hands, wrist, arms, legs and head shaking, also eyes rolled back in his head but after 10 seconds pt was fine.
pt had positive COVID test on 12/27/21; took monoclonal antibodies; was hospitalized from 1/6 - 1/8/22 for HRF associated with COVID 19; dc'd to home; pt returns to ED with increase in SOB and O2 sats at home in the 70s% on 2L O2; admitted to hosp; treated with dexamethasone, ABX, heparin; acute on chronic HRF, pneumonia due to COVID, and bilateral PE; pt worsened, became hypotensive with increase in confusion; went into cardio-respiratory arrest; CPR per ACLS protocol with success; pt expired in the hospital
arm soreness after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness after the shot) 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.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (arm soreness after the shot). In February 2021, VACCINATION SITE PAIN (arm soreness after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-029361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029361:husband case
4 days p/last vax got sx of swelling & pain in joints, fever, weight loss, fatigue, dx ? possible rheumatoid arthritis;
Chills, 103 degree temperature, joint paint, headache, ringing in ears.
pt recvd vax 19DEC95 c/o soreness @ inj site x 2-3 hrs, then soreness gone;soreness worse next morning;next day pain encompassed entire arm & shoulder area;warm to touch; 1" x 1 1/2" red area @ inj site;movement of arm is difficult
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Right arm is red, tender, swollen and reaction site is pass elbow, c/o pain and itching.
Left ring finger and left pinky finger numb. Advised to go to ER for evaluation.
Client came to Center clinic after receiving automated invitation for Johnson & Johnson . Client had already received full series of Pfizer vaccine in December 2020/January 2021, and this was not caught upon screening. Johnson & Johnson vaccine given incorrectly since dose was not needed.
33 yo M with NKA, history of fainting in the past and anxiety about vaccines and needles was in the drive through clinic to receive COVID-19 Janssen vaccine on 3/12.  After receiving the vaccine at 0943 (lot # 1802070) in right deltoid,  the patient began to feel anxious.  He had been or was watching EMS working with another patient who had experienced an ADR. He began to feel "floaty" and noted he was blinking uncontrollably. He reported some tunnel vision/blurred vision. He states he recalled a nurse rubbing on his chest and placing a cold pack on his neck and at this point he began to feel better. He states he was trying to "fight" the feeling and was tensing up his extremities but denied convulsions or any loss
Over course of 10 minutes, patient became red and splotchy on the arms. She had some generalized itching. Monitored for 15 minutes and given 1 dose of Benadryl 25mg orally. Patient stated she took 25mg prior to coming in for vaccination. Patient's husband to drove her to urgent care upon leaving pharmacy.