chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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 34.46 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-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.   This case was linked to MOD-2022-566976 (Patient Link).
chest pain, palpitations, and headache starting at 9am on 6/18 after receiving 2nd dose of pfizer vaccine on 6/13; noted to have a fever on arrival to ED, admitted to hospital and was noted to have sinus tachycardia without arrhythmia; underwent several tests including CT angio, echocardiogram; no clear identified etiology but per discussion with cardiology, suspected transient myopericardial or pleural inflammation from vaccine, improved with motrin
Worsening shortness of breath and fatigue in the setting of diagnosed COVID-19 infection via home test 02/07/2022.
Within 24 hours after immunization, had 10 episodes of total body stiffening and staring, episodes every 3-5 minutes lasting 60 seconds. Fine ever since. No treatment.
No adverse event; first COVID19 vaccination was bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (first COVID19 vaccination was bivalent booster).    Concomitant drugs were not reported. It was reported that patient received 0.5 mL of a Moderna bivalent booster however, reported that patient did not receive any previous dose of vaccine hence might have been the first dose.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658652 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658652:same reporter
Parent reports after first .25cc dose of influenza vaccine on 1/31/05 patient had unconsolable crying for 12 hours and temperature as high as 101.9 not reduced by Tylenol. Parent called hospital advice RN, was told to place patient in cool/lukewarm bath to decrease temperature, Parent stated it worked, fever broke and crying stopped.
CLIENT FAINTED ABOUT 5 MINUTES AFTER RECEIVING THE VACCINE. COLD COMPRESS APPLIED TO HER FOREHEAD, WATER AND FOOD GIVEN AND CLIENT FELT FULLY NORMAL WITHIN 1/2 HOUR. NO INJURIES SUSTAINED IN THE FALL AND HER VITAL SIGNS REMAINED STABLE THROUGHOUT.
Granulomatosis with polyangiitis; Gait inability; Inflammation; Pain in extremity; Vasculitis; Arthralgia; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) in a 71-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.     The patient's past medical history included Thyroid disorder NOS. Previously administered products included for an unreported indication: VACCINES (Shingles shot #2 and Fatigue for 1 week). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CALCITRIOL, LEVOTHYROXINE (LEVOTHYROXIN 0.05 MG KSA), METOPROLOL SUCCINATE (METOPROLOL ACTAVIS [METOPROLOL SUCCINATE]), VITAMIN D3 and CETIRIZINE HYDROCHLORIDE (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) (seriousness criterion medically significant), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Pain in extremity). 22-Mar-2021, the patient experienced VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation), PAIN IN EXTREMITY (Pain in extremity), VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Blood test: inconclusive Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   metoprolo susccinate ER 25mg, Multi vitamin with iron, vascepra 1 GM two capsules twice daily was provided to the patient as concomitant drug. Blood test taken for gout indicated no gout. Wegener's disease was diagnosed  The patient's past medical history included Heart, Vasculitus/Weginer's Disease, Thyroid disorder NOS. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.
Generalized itching later the next day:  9/9/22 .  Rash on R side of chest (under the axilla) erupted on  9/10/22.   Diagnosed as Shingles via telemedicine visit on  9/12/22 despite patient's immunization history of Zostavax and two doses of Shingrex
Pt. rec'd vaccine in our clinic 5/16/11 at 0830 c/o sore throat and tightness of chest in PM hours. Returned to clinic at 830 5/17/11 gave steroid injection and BENADRYL 50 mg.
A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The injection appeared to be low than deltoid and concern it was subcutaneous rather than IM; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: unknown), via subcutaneous route on her right deltoid from 25Jan2021 10:15 to 25Jan2021 10:15 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 04Jan2021 at 10:15 via intramuscular route on her right arm. On 27Jan2021 at 22:00, a blister was noted 2 days after injection that was bigger than a pea but smaller than a dime. The injection appeared to be low than deltoid and concern it was subcutaneous rather than intramuscular (IM). The outcome of the event was recovered on an unspecified date. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "One instance of heart rate abnormality on holster test" (unspecified if ongoing), notes: One instance of heart rate abnormality on holster test; "sciatica" (unspecified if ongoing); "obesity" (unspecified if ongoing); "UPI" (unspecified if ongoing), notes: UPI. The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for Treatment of COVID-19.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Body rash over all body with exception of face, neck and feet.  Terrible itching all over body.
Large red splotchy spot on upper right arm near injection site - Itchy, hot, swollen. Arm still feels sore as of 1/26/2021. Other arm and other parts of body do not have this issue.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
pt recv vax;devel rash approx 3-4 wk later;pt was in contact w/ child in daycare who was also vaccinated&devel fever&lesions;
Low grade fever started around 12:30 pm 11/14/2021, got as high as 100.5.  Broke around 6:30 p.m. 11/14/2015 Swollen lymph node in left arm pit this morning 11/15/2021. Treating with ibuprofen.
Developed Tinnitus after second Moderna COVID-19 shot on 3/13/2021. I laid down on my right side to go to sleep on 3/13/2021 and had sudden onset of hissing/ringing in both ears.
I felt like I had a concussion shortly after I receive the shot. For a few days I felt tired. My headache started almost immediately. These headaches persist on a daily basis since I received the shot three weeks ago. They have not gone away and I did not have any headaches prior to receiving the shot.  I am starting to believe I have permanent brain damage as a result of this damn shot.
The side effects were terrible. It has been 12 hours and  I still feel like I?m dying... a terrible headache,  muscles pain, nausea of the highest sort, I couldn?t eat at all and drink. Whenever I was standing from the bed to go to the restroom I felt I?m about to faint. I needed to lie on the cold tile stone to actually not faint and come back to bed. At 3 pm I nearly lost consciousness. I ate an apple that was miraculously in my room and I felt a bit better, I had the power to walk to the kitchen to pick up the juice. I still experience headache and flue like symptoms but I feel they are wearing off slowly - the reason I?m typing this message. However, the entire day I was dying. I had a breakup at some point and wanted to call for the ambulance ... seriously, terrible side effects. After first dose I felt bad too, but after the second dose I was literally dying and I still do not feel the best.
Injection site became hard.  Ice pack applied.Person has Hx of anxiety attacks in health care situations.  Feels anxious.  3:17 PM:  B/P 160/100 3:22 B/P 144/98.  Person evaluated by paramedic, released.
22MAY92 pt exp crawling feeling itching of skin around chin area on 20MAY92;On 21MAY92 noticed red honey crusted vesicles on chin-no drainage;22MAY92 chin areas skin consisted on red base w/six pinpoint raised non-draining; herpes simplex
Welts on arm and leg; Blisters; severe skin reaction; This case was reported by a nurse via call center representative and described the occurrence of welts in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced welts, blister and skin reaction. Shingrix was discontinued. On an unknown date, the outcome of the welts, blister and skin reaction were unknown.   It was unknown if the reporter considered the welts, blister and skin reaction to be related to Shingrix.  Additional details were provided as follows: The nurse practitioner reported that the patient had a bad reaction after receiving Shingrix. The patient discontinuing Shingrix and would not receive booster due to a severe skin reaction of blisters & welts bilaterally on arms and legs.  No additional details were provided. The nurse practitioner did not have all the information at the time of reporting.
Headache - lasting for 7 days, untreatable with aspirin, Tylenol, Ibuprofen.  Burning feelings in lungs - off and on for 7 days. Stiff neck and shoulders for 7 days.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration where the vials did not undergo any temperature excursion.
Dizziness reported 15 minutes after HEP B Vaccine injection given to employee. Employee monitored for 1 hour for additional signs and symptoms and vital signs. Employee continued to feel dizzy with some light headedness and tingling in jaws. Epi-pen was not administered per assessment of Medical Doctor who validated order not to give.  Employee unable to continue working due to symptoms and was sent home with instructions if symptoms worsen to seek emergency care at local Hospital Emergency Room.  Employee to be followed by Workers Comp. Doctor on 3/15/2016.
Shot given 02/4/13 at 3 pm by nurse 24 hrs. later I experienced total body convulsions, and stiffness followed by complete exhaustion. Had more episodes in car, ambulance and in ER before being admitted the 1st time on 2/5/13.
A consumer report has been received. The report concerns a patient, Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent was started on an unknown date. The reporter stated that the receptionist at the MD's office reported that her husband and child received FLUMIST quadrivalent and both tested positive for influenza B. The outcome of the event of tested positive for influenza B was unknown. The report was considered to be non-serious.
This spontaneous report as received from patient's mother referring to a 1 year old male patient with attention deficit/hyperactivity disorder, developmental delay and drug hypersensitivity to sulfa medications. Concomitant therapies included HAVRIX and unspecified Varicella vaccine. On 09-JUL-2009 the patient was vaccinated with a dose of M-M-R II, 0.5 ml  injection in the right arm for prophylaxis. On 10-JUL-2013 or 11-JUL-2013 the patient experienced swelling in his face, a full body rash and had a high fever (Estimated at 103 degrees) that lasted approximate 7 days. The patient was seen at Hospital Urgent Care but not admitted. No treatment was given. The outcome of the events was reported as resolved. Action taken was not applicable. Causality was not reported.
A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced 1/2 dose FLUMIST administered for dose which started on 10-Oct-2014. The outcome of the event of 1/2 dose FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Swelling at injection site about 4 hours after. Used ice pack and ibuprofen. But got worse overnight, became painful and red with more swelling.
Received FLUZONE vaccine on 9/16/08.  November (date unknown) patient developed abdominal cramps & vaginal bleeding.  OB/GYN evaluation revealed a spontaneous miscarriage.
Patient after the shot would drift off into space with altered mental status and would stare there as well. Likely absence seizures.
Diag w/ Bells Palsy. 12/27 diag Guillian-Barre. According to dr not related to vax. 1/1 problems breathing, taken to ER, put on ventilator. 1/4 still on ventilator but doing better.
PATIENT WAS FOUND DECEASED 3 DAYS AFTER THE SHOT WAS GIVEN.
5:00PM or so the following evening 3/9/21 I started to not feel well. Headache, nausea and general ill feeling. 6:30PM started running fever of close to 108. Fever went up to 102 at its highest. 3/10/21 felt "ok" but stayed home from work. No fever until around 3:00 when it was 100.4.
Too sick to get her shot; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too sick to get her shot) and URINARY TRACT INFECTION (Urinary Tract Infection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis aggravated and Psychiatric disorder NOS.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too sick to get her shot) and URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too sick to get her shot) had resolved and URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications included, 11 other medications for Psychiatric and severe colitis were reported.   Treatment information included, antibiotics was reported.
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness.  I took 2 Aleve before injection and Benadryl 25mg  at 9p after injection.