chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fighting an infection on a hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (fighting an infection on a hospital) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (fighting an infection on a hospital) (seriousness criterion hospitalization). At the time of the report, INFECTION (fighting an infection on a hospital) had not resolved.        Concomitant product use was not provided.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.
Erythema of arm with warmth 1 week after immunization - ? cellulitis.
Patient received a Tetanus shot 10-15-07 stated one hour of the shot, she developed diarrhea, vomited and had fever and chills. I spoke with her on 10-16-07 and she still had diarrhea and was hot, so she went to the ER and was told she was dehydrated.
fever 104 9:00 (4hrs p/vax) variation between nl to 104;cough;13JAN97 called again;still has moderate fever & cough;fever is less (101-102);
TIA/STROKE on 2/23/21.  Full recovery.  No prior history of cerebrovascular disease.
pt recv vax AUG97 & 4wk later recv 2nd dose;In approx OCT97 titers showed that pt was below the cutoff for having immunity;
Patient developed syncope after receiving flu vaccine in left arm. Patient lost consciousness for 5-10 seconds before regaining consciousness and experiencing anxiety. Patient eventually was able to settle down after deep breathing and hydrating over the course of 20 minutes or so. Emergency services were not required.
Oval rash 3x1; following day, rash extended to 9x4 (center raised & darker).
pt recvd MMR vax as a child; pt currently exhibited a lack of response to mumps; n further details were provided;
CONSTANT LEG CRAMPS; COMMON SIDE EFFECTS; CONSTANT PINCHES; SIDE OF THE ARM OF JAB STILL HURTS; LOST STRENGTH IN ARM (WAS NOT ABLE TO OPEN WATER BOTTLE AS USED TO BEFORE); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have potential Guillain barre syndrome and blood clot situation before getting the vaccine. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the patient experienced constant leg cramps. On APR-2021, the patient experienced common side effects. On APR-2021, the patient experienced constant pinches. On APR-2021, the patient experienced side of the arm of jab still hurts. On APR-2021, the patient experienced lost strength in arm (was not able to open water bottle as used to before). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side of the arm of jab still hurts, and the outcome of common side effects, lost strength in arm (was not able to open water bottle as used to before), constant leg cramps and constant pinches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the vaccinator inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The vaccinator then alerted the APRN, who escalated the situation to the operations manager. The operations manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
Urticaria approximately 1 cm in diameter appeared on the patient's right thigh above site of injection.
fever upto 99.8 and chills, myalgia and malaise on day 3
Got really sick; really sleepy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick) and SOMNOLENCE (really sleepy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (Got really sick) and SOMNOLENCE (really sleepy). At the time of the report, ILLNESS (Got really sick) and SOMNOLENCE (really sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
This case is linked to cases 2021SA371630 and 2021SA369738 (same reporter). This case involves an 87-year-old female patient who received expired dose INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (Expired vaccine used). The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ507AC and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. It was reported "A Nurse reporting a medication error described as 20-staff members and 7-Residents received expired doses of FLUZONE QUADRIVALENT MDV from 2020-2021 year after receiving these 6-vials of the FLUZONE QUADRIVALENT MDV in the current years flu vaccine shipment". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported.  Outcome of event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module Regulatory Authority. 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.
Low back pain so I went to neuromuscular massage where I go 1-2x a month. My back seized up in so much pain I could not get off the table. I had to stay another hour and still had to crawl off onto the floor before I could drive home.
Pt admitted to Hospital with large bilateral PE. Tested positive for COVID at that time. Pt states that he is fully vaccinated for COVID. Unable to obtain manufacturer or dates at this time.
Patient was administered Moderna Peds 6mo-5 yrs Bivalent Booster Pink Cap as first dose in series.
RN rpt pt recv 5/7/98 & in the same mo pt exp 2 spots on legs which ``looks like bites,'' slight fever & vomiting
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
1351: Complaint of nausea, diarrhea and not feeling well. Patient vomited yellowish phlegm. Patient denied dizziness, shortness of breath, pain  and difficulty breathing. Patient alert and oriented x 3. Vitals T 97.2, O2 96%, P 86, BP 160/78, R 22.  1420: Vitals T 98.6, O2 97%, P 80, BP 120/62, R 20. Patient discharged from clinic.
pt recv vax 09FEB94 & 11FEB94  devel pain & stiffness in lt shoulder & lt thumb & was seen by MD; APR94 pt recovered; No further details were provided;
Patient has not reported any adverse events. (Duplicate flu shot and FLUZONE HD given within last 4 weeks of each other -> 1 shot at Dr. office and 1 shot at pharmacy).
I was on the last day of my mensuration when I got the vaccine. However instead of ending my menstrual started again heavy. It had since alternated between spotting and heavy bleeding but there hasn't been a day since the vaccine that I haven't been menstruating to some degree. This makes 5.5 weeks straight (including the first week of my normal menstruation before the vaccine).
Cellulitis at injection site (spreading, red, rash, hot to touch and very tender)
Shingles, presentation: scalp, ongoing. Prednisone & anti-viral two weeks.  Daughter also had shingles after first vaccine shot Her work supervisor also had shingles post vaccination, and urgent care doc had shingles post vaccination.
Site of injection at her left arm began to feel warm, ws reddish in the area, had a patch of fine bumps, and felt of pins and needles.  Also experienced severe fatigue the next day.  Patient contacted her PCP who prescribed her oral abx.    Based on my telephone assessment of the patient, this is standard, immunologic reaction to COVID-19 vaccine.  Localized erythema, urticaria, and warmth at site of injection as with vaccinations in general.
Developed a little knot on the eye; This spontaneous case was reported by an other health care professional and describes the occurrence of EYELID THICKENING (Developed a little knot on the eye) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GLIMEPIRIDE (AMARYL), PROGESTERONE, SPIRONOLACTONE, HYDROXYCHLOROQUINE, CEVIMELINE and THYROID (ARMOUR THYROID) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced EYELID THICKENING (Developed a little knot on the eye). At the time of the report, EYELID THICKENING (Developed a little knot on the eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in responsible to the events were not applicable No treatment information was provided
vaccines were administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 54 years 1 months.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna vaccine with NDC code: 80777-0273-99.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master Case
Given Moderna Booster Shot. About a day after I received the booster shot, my left armpit lymph nodes had become swollen and painful. I am currently letting the swelling go down naturally, and will get medical treatment if it doesn't recover.
Patient had generalized seizure, fever. Had fever of 101.4 at admission. Possible atypical febrile seizure, possible meningistis.
Patient received PREVNAR 13 and developed a hard lump (about the size of a fifty cent piece) that was red in color and hot to the touch. It made her arm hurt.
Severe vertigo, sudden onset. Was supposed to get 2nd dose that day but had to postpone. Vertigo improved over the next 24-48 hours but persisted for close to 3 weeks. Relieved with Epley maneuver by ENT.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA258575 (same reporter). This case involves a seven-years old patient (gender not reported) who received a 0.5 mL dose of FLUZONE QUADRIVALENT lot UI998AC via intramuscular route in the left deltoid on 24-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the FLUZONE QUADRIVALENT was delivered later than it should have and the product was out of temperature range. It was unknown if any adverse event was occurred or not following the vaccination. 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. List of documents held by the sender: none.
Red, raised, itchy area on upper arm below injection site. First appeared in the late afternoon/evening of the day the vaccine was received, size approx. 3"x1". By the next morning, the red area had grown to cover most of the outside of the upper arm  (approx. 6"x6"). Started itching on the 3rd day. By the end of one week, the red area was starting to fade. The itching lasted a little longer.
Started feeling achy around 5:30 p.m., around 7 p.m. began experiencing aching and chills.  Took my 10 mg Paxil (usual evening dose).  By around 8:45 had a temp of 99.2 aching, chills, and very hot feverish, and then began experiencing fast heart rate and feeling like I was going to pass out or vomit, wave of nausea and broke out in a cold sweat, chest tightness.  I had taken two 500 mg acetaminophen tablets from 8:45 to 9:30 p.m.  My heart rate would not slow down so 911 was called and I was taken the ER.  I was given IV fluids and Toradol.  Blood work was done and EKG showing sinus tachycardia.  After receiving the IV fluids and Toradol, felt better and was released.
patient reports: headache, muscle ache, fatigue, hives around my neck and an alarming red patch on my arm just below the injection site; while symptoms lessened over time, as of today (day 4), they are still ongoing.  Red patch does not look like hives, borders are regular, slightly raised, painful and warm to the touch and quite itchy.  Sx resolved as of day 5 or 6.
Starting exactly one week after the first shot, on Saturday June 19th, I started to feel extremely weak and cold, I checked my temperature.  My fever was 101.5.  I was having extreme muscle aches and cold chills.  On Sunday, June 20th, my fever continued as 101.6 and I started to have joint pains along with the muscle/body pains.  I had a major headache and I started to get extreme diarrhea, every 20-30 minutes.  When I stood up my head would throb, and my ears would ring, and I would get the ?wa-wa?s? in my ears and I would feel like I was going to pass out.  It felt like there was extreme pressure in my skull almost.  On June 19th I started taking Tylenol to help reduce my body pain and fever.  It was not working so on the 21st I switched to Motrin.  My fever continued while taking Motrin, but it did start to go down.  I started drinking Gatorade on the 19th and then I switched to Pedialyte on the 21st, Pedialyte seemed to help more.  I did not have an appetite and did not eat.  The cold chills and fever continued until Wednesday morning, June 23rd.  Once my fever broke my body aches started to subside.  However, the diarrhea and headache has continued even until currently, June 29th.
Patient presented at vaccination table after having documents and appointment reviewed by non-clinical staff, and identity was confirmed by nurse vaccinator using two unique identifiers (including DOB). Nurse vaccinator reviewed patient's responses to screening form completed in PrepMod and screened patient to confirm she was feeling well, had no history of anaphylaxis, does not carry an epi-pen for allergies, and had not received COVID vaccine previously. RN vaccinator educated patient on possible side effects of Moderna product. Patient indicated she wished to be immunized, received Moderna vaccine, and proceeded to observation area where she waited for fifteen minutes before departing from clinic without reporting any adverse event. Patient was later found to be five months under the minimum age of 18 years for receiving Moderna COVID-19 vaccine, thereby rendering the medication as administered outside the age limit of the applicable order.   Immediate Action/Intervention: Patient was under observation for CDC-mandated 15-minute period following vaccine administration. Upon review of records and discovery that dose was administered to patient who was five months too young to be eligible. Director of Nursing was informed of error and tasked with completing required documentation and performed root cause analysis.
PT. RECEIVED VACCINATION ON 10/22/08. CALLED PHARMACY ON 10/23/08 AND STATED THAT THEY HAD PAIN AT INJECTION SITE AND REDNESS DOWN TO ELBOW AREA. PHARMACIST INSTRUCTED TO KEEP AN EYE ON IT FOR A DAY OR TWO AND TO REPORT IF THE REACTION DIDN'T RESOLVE IN A COUPLE DAYS.  PT. ENDED UP GOING TO DOCTOR ON 10/27/08 FOR TREATMENT AND RECEIVED ANTIBIOTIC FOR INFECTION.  PT REPORTED LATER IN THE WEEK THAT THE PAIN AND SITE WERE IMPROVING WITH CONTINUED ANTIBIOTIC TREATMENT.
Pt recv vax 24MAR94 & hospitalized for the tx of pyelonephritis & lt flank mass; BC same day was Haemophilus flu pos; pt transferred to a 2nd hosp on 12JUN95 & discharged 22JUN95 dx lt non-functioning kidney 2ndary to burned out ureteropel
15 minutes after client received vaccine client stated that she felt dizzy and weak.  Vital signs obtained by EMS  BP 119/72, Pulse 72, Temp 99, O2 sat 96%  Blood Sugar 107 at 1:43 pm.  Client was wearing 2 face masks.  She removed the mask and stated she feels better.  States she was hungry.  After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.
24 hours after vaccine was given right deltoid became red, swollen and warm in 8cm x 7cm area.
12 x 17 cm area of erythema and warmth (L) deltoid.