chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 16-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Patient reports hives occuring over all of her body about 3 days after receiving the Moderna COVID vaccine.
Pt experienced a fever of 99.9, noted about 8 hours post vax. Pt experienced a seizure about 10 hours post vax.
After taking the 2nd  shot about 3 weeks after came down with a sore throat, running nose, and a cough. could not get rid of cough went to Dr who submitted a prescription can not remember the name but did not take it due to it was too expensive. So just keep taking over-the-counter cough medicine until it was gone which took a few weeks.
Pt got shot on 7/23/13, pt's mother came in on 7/25/13 and stated that pt had a big red circle that was swollen and felt hot to the touch on the (R) upper thigh/deltoid.
Information has been received from a medical assistant concerning a 25 month old white male with an amoxicillin clavulanate potassium allergy who on 05/13/2003 was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live.  Concomitant vaccinations on that same day included the first dose subcutaneously in the left thigh of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The MA reported that on 07/11/2004, the patient was seen developed chickenpox like rash characterized by a few spots on his abdomen.  On 07/12/2004, the patient was seen in the medical office with spots on his abdomen, legs and face with papules many with a rose petal patch.  The patient was noted to be afebrile and had no itching.  Treatment was not required.  It was also noted that the patient's brother had shingles three months prior.  In 07/2004,  7-10 days after onset, the patient's chickenpox like rash resolved.  Additional information is not expected.
BODY ACHE; CLAMPING; CHILLS; FATIGUE; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy.  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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. . The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced clamping. On 09-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, sweating, clamping, and chills on APR-2021, and had not recovered from fatigue. This report was non-serious.
This patient received his first Moderna COVID vaccine on 2/5/21. He was scheduled for a COVID Vaccine 1st dose appointment today in error and received the Moderna COVID vaccine today, 2/22/21.  He did not experience any immediate adverse events with today's vaccination.  His PCP will be calling him daily for the next 48 hours to monitor for adverse events.
loss of taste; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6206), via an unspecified route of administration in left arm on 15Mar2021 at 12:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 at 06:00, the patient experienced loss of taste. On 18Mar2021, the patient underwent nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event loss of taste was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Urticaria; no respiratory, nausea or vomiting or other problems. Mother gave Benadryl and hives were gone the next morning.
mom states pt irritable & crying off & on all noc; mom reports temp was 105R this AM;
Felt really weak; Shaking; Itchy; Wheezing; Had to be on bed for 2 days and a half; Fever; Sore arm for 3 days; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 3 days), ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (VENTOLINE [SALBUTAMOL SULFATE]) for Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm for 3 days). On 01-Jan-2021, the patient experienced ASTHENIA (Felt really weak), TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of UNK dosage form. On 01-Jan-2021, PAIN IN EXTREMITY (Sore arm for 3 days) had resolved. On 06-Jan-2021, TREMOR (Shaking), PRURITUS (Itchy), PYREXIA (Fever) and WHEEZING (Wheezing; Had to be on bed for 2 days and a half) had resolved. At the time of the report, ASTHENIA (Felt really weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, Oxygen saturation: 91 % (Low) went down to 91%. On 02-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   Concomitant medications included few medicines(inhaler), steroids, blood pressure and cholesterol medicine. It was reported that the patient had skipped steroids, blood pressure and cholesterol medicine since he thought he had COVID-19. The patient got "barely" a sore arm for 3 days. It was reported that the patient felt better on 06-Jan-2021 but was still  a little weak at the time of report. The severity of the events were reported as 9/10.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Red, Hot, Swollen area from deltoid of left arm to elbow possible celulitis.
By parent report child developed high fever, excessive fussiness, decreased appetite, knot under injection site and pain at site within 2 days of injection.(injection thurs pm)36-48 hours after injection (sat am) fever was noted to be 104 degrees and parent reports much difficulty controlling fever with tylenol, called local ER on weekend-was given directions to increase tylenol and add ibuprofen in addition if needed to control fever, tepid bath for child. called local doctor on monday, no new instructions, by then fever down some but child still had pain at site, lack of appetite. child to local dr for appnt wed. for evaluation
Initial case report received from a nurse via MedCom on 23 OCT 2009. A 3-year-old female patient, was vaccinated with FLUVIRIN (batch no UT3178DA) i.m. into the left deltoid on an unknown date. Attempted to confirm lot number. The caller stated that the product administered was FLUVIRIN. No adverse event was reported. Reference no. NA09-006928. Follow-up information received on 04 Jan 2010: Batch no. for FLUVIRIN was reported as UT3178DA.
Two weeks after I had the second shot (detailed above) I began having vaginal bleeding (light red, spotting). I am 21 years post-menopausal with NO bleeding prior to this. Dr. ordered an ultrasound which showed thickened, uneven lining of uterus, then I had a diagnostic D&C and polyp removal on Sept. 17th. Pathology showed Stage 1 Endometrial Cancer. Was referred to a surgeon and will undergo a hysterectomy.
A dose of Moderna was given today outside the 12 hour window after 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture) had resolved.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow u received which contains no new significant information.
The vaccinator reports that she attempted to administer the vaccine using a 1cc vanishpoint syringe/1inch needle, she inserted the needle into the deltoid, and when the vaccinator pushed the plunger the vaccine leaked out at the joint between the needle and syringe,  and dripped down patient arm, vaccinator believes less than half (if any)  vaccine was inserted into the patient.  another dose of vaccine was given, with the agreement of the patient.
INTENSE SNEEZING THAT LASTED FOR ABOUT 4 HOURS ITCHING
Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.
This spontaneous report as received from a certified medical assistant refers to a patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 lot# L040054 with expiration date: 26-DEC-2017 and lot# M016193 with expiration date: 24-APR-2018 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent a temperature excursion at 9 degrees Celsius for 1 minute. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
a 55 years old patient received an expired dose of Tenivac vaccine/No AE; Initial information received on 01-Apr-2020 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant).  This case involves a 55 years old female patient who received an expired 0.5 ml booster dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5882AA, expiry date: 08-Mar-2020 via intramuscular route in the left deltoid o 01-Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Covid Arm.  First 24 hours my arm didn?t really hurt.  Then became red near injection site, warm to touch, firm, and itchy.  So far it has been over three days.
Mom came in for PPD reading 9AUG91 & stated pt had a very high fever, legs were sore; Did not take pt to MD & pt is still warm today;
Bilateral ankle swelling, pain beginning 06/13. Admission to hospital on 06/14. Hospitalized at time of report. Documented bilateral ankle inflammatory arthritis. Reactive Arthritis.
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine and experience not responding to therapy. The physician reported that employees in a clinical program at the hospital were non-responders to the hepatitis B vaccination series. It was unknown with hepatitis B vaccine the employees received. At the time of reporting the outcome of the event was unspecified.
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR
Pt left after vaccine without s/s adverse reaction, received phone call after leaving work that pt had returned to office with C/O dizziness, labored breathing and pressure like feeling over right eye.
Hives/swelling/itchiness/redness at injection site about 5 inches long a week after injection.
Severe congestion/very congested; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Severe congestion/very congested) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS CONGESTION (Severe congestion/very congested). At the time of the report, SINUS CONGESTION (Severe congestion/very congested) outcome was unknown.           The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No treatment information was provided by the reporter.  No concomitant medications were indicated.
Developed Shingles on 4/10/21 Psoriasis broke out badly and I think I have onset of psoriatic arthritis now
Initial report received from a health care professional on 18 NOVEMBER 2014. An adult female patient, whose medical history and concomitant medications were not reported had received a 0.5 ml syringe dose of FLUZONE QUADRIVALENT (0.5 syringe, lot number: UI231AB, expiry date-30 JUN 2015, dose number, route and site of administration was not reported) on an unspecified date. On an unknown date after vaccination patient had experienced very red, inflamed and hot to the touch swollen arm, size of reaction 4x4 inches and painful and radiated down the arm/arm felt heavy. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: none.  Follow-up information received from a health care professional on 10 MARCH 2015. It was reported that the vaccine was administered on 07 NOVEMBER 2014 and on the same day at 8 PM the events had occurred. It was also reported that patient had not received any other vaccine within four weeks prior to the date of vaccination and had no illness at the time of vaccination. On an unspecified date the patient had recovered from the events.
pt recvd vax;n,ha,fever,d,aching bones 3-4 days p/ shot;saw MD;gave rx, pt not aware of what med was;cont to have cough,tired & some occasional n;infl virus pos;
Night sweats; Fatigue; Chills/fever; Terrible headaches; Injection site hurt worse with the first shot than the 2nd dose; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 82-years-old female patient received BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical previously received BNT162B2 as dose 1, single for COVID-19 immunization and experienced injection site hurt worse with the first shot than the second dose. On an unknown date, the patient experienced night sweats, fatigue, chills/fever, terrible headaches, injection site hurt worse with the first shot than the second dose. The reporter wanted to know the efficacy after one dose, are the side effects in the second dose worse than the first dose, is the second dose the same medication, is there any research about giving different doses to smaller people, who weigh less as the reporter had COVID-19 in Mar2020, only weighs 108, since the patient had COVID-19, is that side effects were just like COVID, maybe only one dose is enough instead of two and was it too late to get the second dose. The clinical outcome of all the events was unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
had most side effects listed for vaccine - headaches, body aches, cough, runny nose, malaise.
Child had approx 3 inch circle of redness and swelling around the injection site with tenderness, Ice applied to area and given 25mg po of Benadryl.
3mo infant developed fever 103 & generalized rash following OPV/DTP immun; treated w/APAP;
Hives started 16 days after 2nd Covid vaccine.  Primary Care physician prescribed antihistemines on 11/16, but they still got progressively worse until December 16th where I had to go to Urgent Care as my entire mouth swelled and I needed a steriod shot. Lymph nodes appear swollen on MRI and Ultra Sound still 1/31/2022.   I also developed a lump in my right breast mid September 2021 that could be felt.  I have since been diagnosed with triple negative breast cancer and a second seperate breast cancer was determined on 1/31, still awaiting reports on receptors. Based on the time line of the cancer, I truly believe it is linked to the vaccine and that my body is attacking itself.  never have been allergic to anything before and now my entire body always is red and feels warm.
first dose given 44 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago) outcome was unknown. Not Provided      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.   The pharmacist wanted information if patient can get second dose. concomitiant medication use was not provided by the reporter  Treatment information was unknown.