chrisvoncsefalvay/vaers-outcomes huggingface dataset:
49 Y male with history of HTN, HLD, DM2, ESRD (recent transition from PD to HD, T/Th/Sat), paroxysmal Afib (on warfarin), gout, ACD, recent admission 12/16 - 12/20 for hypervolemia (new start HD at that time) who presented 1/11/22 from home (ALF) with weakness SOB, chills, no fevers. He was found to have acute hypoxemic respiratory failure, Covid positive 1/11/22, abnormal troponin. Normal lactate.  CT chest with large left pleural effusion with atelectasis. Not short of breath at rest.  Started on antibiotics for possible parapneumonic effusion and Decadron for covid pna. No Remdesivir given ESRD. Thoracentesis 1/14/22, removal of 1.3 L of fluid.  Cultures so far negative.  Clinically improved, weaned to room air. Ambulatory on RA with O2 sats greater than 92%. Eating well.  CRP 1.6  from 8.9 on admission. D-dimer 2.71 from 3.30.    1) COVID Pneumonia, Acute hypoxemic Respiratory failure (resolved), PNA, L effusion- Symptom onset on 1/10. COVID positive on 1/11. Last fever unknown.  Vanco 1/11-15.  Zosyn in house 1/11-1/16. BCX neg.              - Vantin to complete 7 days total 1/17/22.               - consider CXR in 2 weeks to f/u L effusion             - Decadron 6mg PO qday for up to 10 days (1/11-1/19 ) given high risks for complications.              - Remdesivir not given as pt is ESRD              - Protonix for GI prophylaxis             - s/p Thoracentesis 1/14/22. GS no organisms. F/u pleural fluid cytology, and culture so far negative.              - continue isolation per Regional/Local ID guidance. Until 01/31/22.     2)  Non ischemic myocardial injury from Covid infection, pna. Trop  0.12 x 2.    3) HTN, HLD - PTA Metoprolol. Amlodipine increased to 5mg bid.  Added Hydralazine 25mg TID for HTN. Continue to adjust medication as outpt as appropriate.     4) AFib:  - on Warfarin. F/u with AC clinic, next INR on Tuesday on HD 1/18/22                 - PTA BB     5) DM: Last hgba1c 7.2. Pt states no longer takes NPH or regular insulin as his AM sugars are usually < 100. BG on admission was 71             - Here on low dose NPH and regular insulin (as he is on steroids) to tirate as outpt once off steroids.              - Low ISS   6) ESRD on HD             - Continue T,Th,Sat HD sessions at Covid center. After finish isolation he can go back to HD  MWF.              - Continue nephrovite              - Pt also taking Phoslo and Renvela .   -  ANEMIA: Suspect AOCD. Baseline hgb 8-9. No e/o bleeding             - iron tabs    - Gout:     - Continue PTA allopurinol   - Undiagnosed OSA: pt desaturates occasionally when sleeping requiring on and off oxygen. He has been told he needs sleep study and CPAP.              - e consult to home sleep study for CPAP sent.    -  Followed by derm for rash. Acne vs. Kyrle's disease.             - PTA Doxycycline 100mg Q12h resume.              - PTA Atarax 10mg daily PRN itching   Diet: DIET, RENAL DVT prophylaxis: As above Code Status: Full Code Reason for Hospital Admission (Admitting Diagnosis):  Covid infection
I was driving my personal vehicle northbound on interstate when I passed out behind the wheel. I felt nauseous the sky brightened up and passed out. My Dr's diagnosis was vasovagal reaction secondary to the Covid vaccine. no prior issues
gave two Moderna vaccines that were expired by 14 hours/ the vaccine was in a punctured vial; 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 EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours/ the vaccine was in a punctured vial) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours/ the vaccine was in a punctured vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave two Moderna vaccines that were expired by 14 hours/ the vaccine was in a punctured vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Red, itchy rash at site of injection that did not appear until 12 days after injection. It lasted about three days.
Skin rash and ankles and hands; This is a spontaneous report  from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 16:00 (at the age of 20-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroid. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and "BCP." The patient did not have any known allergies. On 16May2021 at 10:00 the patient experienced skin rash on ankles and hands. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of skin rash was recovering. It was also reported that since the vaccination the patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The site where the injection was has never stopped being painful and sore and I can't lift arm above head or in other positions. This shot was high on the shoulder and I have never had problems before in the many years of flu shots.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional via another manufacturer (Pfizer) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: left ventricle dysfunction, tricuspid regurgitation, mitral regurgitation, aortic regurgitation, hyperparathyroidism, hypercholesterolemia, thyroid nodule, obstructive sleep apnea, colon polyps, seizure disorder, post-traumatic stress disorder, depressive disorder, osteopenia, sulfa drugs allergy, iodinated agents allergy, and drug allergy (Morphine). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, ascorbic acid, calcium/colecalciferol, escitalopram, gabapentin, ibuprofen, lactobacillus rhamnosus, magnesium citrate, melatonin, metoprolol tartrate, rosuvastatin, ubidecarenone, vitamin b complex and multivitamins. The patient received additional 2 dosage of non-company suspect vaccine of pfizer (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 16-NOV-2021 and 10-MAY-2022 for prophylactic vaccination.  On 17-MAY-2022, the patient developed symptoms of covid-19 (coded as confirmed covid-19 infection) (dose number in series 2). On 19-MAY-2022, the patient tested positive at home (confirmed clinical vaccination failure) (dose number in series 1). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 20-MAY-2022 and last dose on 24-MAY-2022 for treatment of covid 19 and was recovered. On 28-MAY-2022, tested negative on rapid antigen test and on 31-MAY-2022, the patient developed fatigue, headache and increased congestion (dose number in series 2). On 01-JUN-2022, Laboratory data included: COVID-19 virus test Positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint number: 90000235164.; Sender's Comments: V0: 20220617400-Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
All of a sudden I got flushed in the face; Swelling; This is a spontaneous report from a contactable consumer. A 74-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 03Jan2021 16:04 at single dose for COVID-19 immunization. The patient's medical history was not reported. It was reported that patient is taking an unspecified blood thinner. The patient reported "My first Covid-19 Pfizer and had not any symptoms or any problems but all of a sudden got flushed in the face, and started little tiny bit of a swelling on an unspecified date and no problem it is already gone away. The outcome of the events was recovered.
Right upper arm swollen and warm to touch. Large raised circle 2.25 inches in diameter. Smaller raised circle 1.5 inches in diameter. Complains of pain from right shoulder to elbow.
Pt developed headache and dizziness immediately after receiving her second dose. This adverse reaction resolved on its own over the next 15-30  minutes.
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well.  I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized.  Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2.  Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol.  Did not go to work on 2/26/21.  Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore.  Placed cool compresses on my breast, arm pit and arm where vaccine was given.   Took Tylenol. Still fatigues, achy, with sore shoulder muscles.  Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol.  3/1/21, called Dr. Still a bit achy and arm still tender
Severe chills, headache, Nausea, Muscle Aches. Fatigue as well as severe swelling, reddening, in large part of left forearm starting about 12 hours after injection and lasting to some degree for 48-72 hours after.
I received my J&J vaccine at around 3:00pm. By 10:00pm, I was feeling very tired and achey and went to bed. I woke up at 2:00am with a fever of 102.5, a terrible headache and unbearable body aches. I took some ibuprofen and tried to go to bed but began vomiting. This lasted for 3-4 hours and I was unable to sleep. The next day I began to feel better in the afternoon but by 6:00pm the fever and aches worsened again and I began vomiting uncontrollably, about every 10 minutes. I couldn?t keep anything down, even water. I had a virtual urgent care visit and the doctor ordered me to go to the emergency room. At the ER, the doctors determined I was severely dehydrated. I received 2 bags of IV fluid, nausea medicine and pain medicine. I spend about 3 hours in the ER before I was sent home. I had to keep taking nausea medicine to prevent vomiting for the next day or so.
This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle soreness), EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The patient's past medical history included Hypertension (constant for a while). Concurrent medical conditions included Drug allergy (Allergy to Prevacid, reaction is chest pain.), SLE nephritis since 24-Jun-2021, Tension headache (once a week usually, can't recall (tension type headache)) since 28-Feb-2021 and Knee pain. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), HYDROXYCHLOROQUINE, PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D [VITAMIN D NOS] and FOLIC ACID for an unknown indication.On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial). On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Muscle soreness). On an unknown date, the patient experienced DIZZINESS (Lightheadedness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial) had resolved. On 21-Aug-2021, DIZZINESS (Lightheadedness) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Muscle soreness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reported that the pharmacist believes the patient must have had some type of transplant. Reported that the patient hadn't taken any medications to alleviate symptoms. This case was linked to MOD-2021-293779, MOD-2021-293783 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Patient demographic details, medical history, concurrent conditions, concomitant medications were added. First dose and second dose details and events were updated.
Low grade fever and no other sx's besides fatigue and feeling feverish; started night of 4/3/21 and lasted 24 hours or so; fine the next day. Fever has recurred several times since then, always without any other sx's (occasionally headache). Fever has ranged from 99.1 to 102.0; my average temp is about 97.3 degrees. It seems that the frequency and duration of the fevers is worsening. It started out lasting only a day, but the last episode lasted for a week (PM fevers only that week)
Site: Pain at Injection Site-Mild, Systemic: blood clot in the mouth and blood shot eyes-Medium, Additional Details: per patient she developed blood clots in her mouth (still has it off and on) after the 1st dose and blood shot eyes after 3 to 4 hours after 2nd dose.  Eyes were checked by her eye doctor and is fully recovered.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender not reported) who received a dose of vaccine PENTACEL on an unspecified date (lot number not reported via unknown route and site of administration). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that when the box was opened there was only one vial of the ACTHIB portion remaining, a patient somewhere may have received an incorrect dose. It was a case of actual medication error due to inappropriate reconstitution technique and incorrect dose. No information on adverse event reported. The patient outcome is reported as Not Applicable for from PENTACEL there was only one vial of the ACTHIB portion remaining. 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 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.
12 hours later 10:00pm experienced chills, body aches, fever headache. 1/8 at 7:00am woke up itchy covered in hives head to toe. Hives resolved after topical and oral antihistamine taken.
Secondary syphilis; Spontaneous urticaria exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of SECONDARY SYPHILIS (Secondary syphilis) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SECONDARY SYPHILIS (Secondary syphilis) (seriousness criterion medically significant) and URTICARIA (Spontaneous urticaria exacerbation). At the time of the report, SECONDARY SYPHILIS (Secondary syphilis) and URTICARIA (Spontaneous urticaria exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered SECONDARY SYPHILIS (Secondary syphilis) and URTICARIA (Spontaneous urticaria exacerbation) to be related.    No Concomitant medication were reported  No Treatment information was reported  Company Comment:  This is a literature non-study case concerning young adult male patient of an unknown specific age with no medical history reported, who experienced the unexpected serious (medically significant) event of Secondary syphilis, which occurred after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient also noted appearance of a heterogeneous rash the day after mRNA-1273 vaccination and spontaneous urticaria exacerbation post mRNA-1273 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning young adult male patient of an unknown specific age with no medical history reported, who experienced the unexpected serious (medically significant) event of Secondary syphilis, which occurred after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient also noted appearance of a heterogeneous rash the day after mRNA-1273 vaccination and spontaneous urticaria exacerbation post mRNA-1273 vaccination. No further details about the diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Patient developed a redness on face and neck which was described as a rash.-Mild, Additional Details: Two hours after the administration of the vaccine, the patient developed redness on his face and upper body. Within 20 minutes, the redness was subsiding without any treatment or intervention. The facility was continuing to monitor the patient.
rt knee swollen to size of grapefruit, stiff & painful water had to be drawn from knee on 11FEB93; swelliing has now gone to lt wrist, stiff & painful;
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with her first dose of GARDASIL. On an unspecified date, the patient received her second dose of GARDASIL. The patient developed a blister on her chest all the way up to her neck including her face "1 day after getting the second dose of GARDASIL." The reporter learned of the adverse experience through a colleague who is the treating physician of the patient. The patient sough unspecified medical attention. No additional information was provided. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883 with expiration date 02-OCT-2017), orally, which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness Soreness Tired It?s been one week and I now can?t lift my left arm over my head
Information has been received form a licensed practical nurse concerning a 12 month old male with upper gastroesophageal reflux and no known drug allergies who on 22JAN2004 at 11:30am was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant therapy included ranitidine HCl. There was no illness at the time of vaccination. The nurse reported that a few minutes after administration, the pt developed a flat are of redness at the injection site. Inside of the redness was a raised white rash described as hives. There was no itching and the reaction was localized. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Follow up information was received from a registered nurse who indicated that on 23JAN2004 at 11:30am the patient had an immediate reaction to the vaccination. It was described as a localized wheal and flare that occurred before the needle was out of the thigh. There were no other signs and symptoms. It was also noted that there were no adverse events following prior vaccination. No further information is expected.