chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee states that she experienced hives with rashes to both hands which then spread to upper back with lip swelling on the right side only after receiving the Influenza Vaccine on 9/22/21. Employee has Eczema.  Employee self-treated with Benadryl OTC Dosing and spoke with her PMD on 9/23/2021 whom suggested that she used Zyrtec and follow up with an Allergist for further testing. Employee saw me 2 days after receiving the Flu Vaccine on 9/24/2021 and her symptoms was getting better.  Employee reports that her rashes had gotten better with mild itching  and no more lip swelling. Also Employee has no left arm pain, redness or swelling at the injection site.
woke up with a gout flare up, which I havent had since starting my allopurinol treatment; gout flare up; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 11:00 (at the age of 38-years old) as a single dose for COVID-19 immunisation. Medical history included gout which was ongoing at the time of reporting. The patient had no known allergies to medications, food or other products. 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 vaccine. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), all for unknown indications, from unknown dates and unknown if ongoing. On 12Mar2021 at 03:00, the day after receiving the vaccine, the patient woke up with a gout flare up, which he had not had since the allopurinol treatment. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout flare up was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Recurrent urticaria beginning 3 days after receiving Pfizer monovalent Comirnaty 12+ 23-24SDV. NDC 00069-2362-10 on 10/8/23 Urticaria distributed over trunk, limbs and face. Last episode 10/29/23 Treated PRN with Allegra and NSAIDs which relieved symptoms
Had first injection in the upper left arm and now arm is still extremely sore and makes for restless sleep. Second injection done in right arm and know soreness except slight at injection site if touching it.
Some side effects (didn't mention which); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects (didn't mention which)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects (didn't mention which)). At the time of the report, VACCINATION COMPLICATION (Some side effects (didn't mention which)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Urinary Tract Infection; Inappropriate dose of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00115719) for COVID-19 vaccination.     Concurrent medical conditions included Heart rate irregular. Concomitant products included METOPROLOL for Heart rate irregular.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 19-Feb-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). The patient was treated with TETRACYCLINE for Urinary tract infection, at a dose of 500 mg, for 7 days. On 19-Feb-2021, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: event outcome updated.
t101.2, tachycardia, weakness by 11PM on 22JUN92 recovered by 9AM 24JUN92;
On April 26th, I had fever, chill's, nausea and body aches.  It took over the whole weekend for the body aches to subside.  The nausea has still not gone away. I have noticed that I have started and now lost my ability to spell. I can see the word but I have a hard time getting out. I am now experience sever tremors.
16 year old patient received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) 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.   Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up report  received on 06 Jul 2021 included non-significant information On 20-Jul-2021: Follow up report  received on 20 Jul 2021 included non-significant information
Continuing pain at flu injection site; decreased range of motion of left arm. Unable to lift arm, move arm to back or extend arm.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old male. Initial information was processed with the additional information received on 18-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient had suspected clinical vaccination failure and suspected covid-19 infection (symptoms of sore throat, stuffy nose, headache and body ache). Laboratory data included: COVID-19 rapid test (NR: not provided) was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212145.; Sender's Comments: V0-20220130118-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. 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.
Severe itchiness and redness starting from groin area spreading to inner thighs and hips heavily then dispersing to upper body, neck, and extremities. No other symptoms was experienced. Itchiness did not resolve by day 5, therefore I visited urgent care center on Oct. 26, 2021 and prednisone 40 mg daily x 7 days, acyclovir 800 mg  five times daily x 7 days, Benadryl 50 mg every 4-6 hr, and Claritin 10 mg daily was prescribed.
Immediately after shot I felt pressure all over my body and my face tingled. The pressure eased off quickly but the tingling lasted until the next day then my face felt like I had been punched. I still have a little face swelling and itching with raised red spots on my face that move around to this day.
This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown. Approximately in 2004 (reported as "12 years ago") the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, expiry, route and batch/lot# were not reported). The patient had received two doses of PREVNAR 13 one dose of on an unspecified date in January 2015 and then a second dose on an unspecified date in January 2016 (extra dose administered). Approximately in 2016 (reported as "currently"), the patient was diagnosed with diabetes and dyslipidemia and it could not be determined that if the patient experienced these conditions before or after receiving the dose of PNEUMOVAX 23. The outcome of diabetes mellitus and dyslipidaemia was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. There was no product quality complaint involved. Upon internal review "diabetes" was determined to be medically significant. Additional information is not expected as the reporter did not wish to be contacted.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day; everyone ignored the parent signature for under age 18 on a Moderna day.
Pt vaccinated with HBCV/DTP developed red itchy rash on all extremities ears & cheeks not on trunk. Referred to ER. Small hives on cheeks & extremities that were fading. Benadryl prescribed.  No fever, no reaction at inj site.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 08-OCT-2012 the patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # was reported as H012521, exp date: 09-OCT-2013) exposed to temperature that could not be supported. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 09-DEC-2013 the patient was vaccinated with expired ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect was reported. This case is linked to the same reporter cases: MARRS 1402USA013045, 1402USA013518 and 1402USA012520. Additional information has been requested.
Over 4 months after 2nd dose of COVID vaccine, I developed moderate  acute acute abdominal pain.  At first generalized, then moved to right mid and lower quadrants.  Associated with loss of appetite and low grade fever.  After 4 days, I contacted my PCP.  Blood work showed elevated C-reactive proteinof   39.3 mg/L (reference range <8), normal white count.  Abdominal ultrasound inconclusive.  Abdominal CT showed "nonspecific enteritis" of terminal and distal ileum.  Pain gradually resolved without antibiotics. C-reactive protein returned to normalon retest July 6th.
patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 20-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration was reported as 07-May-2021.   This case was linked to MOD-2021-364940 (Patient Link).
Information has been received from a physician concerning a 19 year old female patient with penicillin allergy who was vaccinated intramuscularly with 3 doses (0.5ml each one) of GARDASIL on 31-JAN-2008 (lot #659962/0571X) respectively. The physician reported that the patient had a PAP smear that was positive to all 4 types of GARDASIL. Prior to starting the GARDASIL vaccine the patient had a PAP smear that was negative to all 4 types of GARDASIL (date not reported). A biopsy from a PAP smear was done on 18-DEC-2008 showed the patient has 13 high risk types of HPV and 5 low risk types of HPV, this information came from the patient's obstetrics and gynecology physician. Also performed were "serologic test for other sexually transmitted diseases" but the results were not reported. The patient sought medical attention in the office visit. The outcome was reported as not recovered. Follow-up information was received from a physician via medical records. It was reported that the patient with a history of unspecified vaginitis and vulvovaginitis was vaccinated into the right arm with the first dose of GARDASIL (lot # 659962/1740U) on 31-JAN-2008 at 10:00, with the second dose of GARDASIL (lot # 659962/1740U) into the left arm on 15-MAR-2008 at 10:00 and with the third dose of GARDASIL (lot # 659962/0571X) into the right arm on 04-AUG-2008 at 10:30 respectively. The physician reported that the patient had a PAP smear that was positive for multiple papillomas strains of HPV; including the ones in the vaccine. The pap sample collected on 18-DEC-2008 was sent for HPV testing and results reported on 29-DEC-2008. The patient's test results were reported as (patient had Pap IG, HPV-h+Ir) Epithelial cell abnormality, atypical squamous cells of undetermined significance. HPV results: HPV, high-risk: positive; HPV low-risk: negative. The physician reported that event required medical/surgical intervention. Additional information was received from the physician. It was reported that the physician felt that "the vaccine did not work for the patient". It was reported that there was no concomitant medication at the time of vaccination with GARDASIL. The physician also stated that the patient had a colposcopy procedure performed (No results provided). At the time of this report, the patient's outcome was unknown. This is one of several cases from the same source. Additional information has been requested. All available medical records will be provided upon request.
patient with h/o Potts Dz.  onset of tachycardia, presyncope, diaphoresis and facial flushing 5 mins after vaccination.  had similar physiologic response after first dose that lasted 24 hours.  no prev h/o issues with vaccinations, injections or blood draws
Left arm enlargement, swelling, erythema to antecubital fossa. No systemic symptoms.
Pt returned from arduous bike ride, took long time in bathroom, wife entered, pt started to speak, turned blue and fell to floor. CPR attempted, EMS took to ER where pulseless. Ventricular tachycardia found. Intubated, CCU care, minimal brain activity, died on 4th day.
Patient stated she felt short of breath, developed chest tightness, became diaphoretic immediately after vaccine administration. Patient also reported light-headedness. 50 mg oral diphenhydramine was given and patient was sent to the emergency room for further evaluation.
reported exp chills, dizziness, nausea, h/a, muscle aches w/in 3hr of vax;
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area.  3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
pt recvd 1st dose of Engerix-B & devel soreness @ inject site; p/2nd dose soreness cont progressing to rt arm; still has pain;
Starting the evening of getting vaccines had flu like symptoms. Body aches, excess lethargy and about 12 hours later a very itchy rash which started behind his knees and spread throughout his body. Caladryl lotion helped decrease the itching but did require BENADRYL in order to sleep.
Fever, irritability, cough, dyspnea, pallor, decreased motor activity.  Symptoms occurred within 2-3 hours of administration.  Lasted 30 min.
Patient was admitted on 2 separate occasions,  presents today following a fall at home.  Patient reports that she was trying to eat breakfast when she fell.  She denies tripping or losing her balance.  She denies any chest pain, shortness of breath, cough, abdominal pain, or nausea/vomiting.  She states that she has had pain with urination.  Per family she has had foul-smelling urine as well.  They have noticed that over the past few days patient has been progressively worsening . Found to be COVID positive, isolation precautions. Cardio consulted. 1/14 ID consulted. 1/16 blood cultures pending 1/18 C. Diff positive. Oral vanco for 17 days. Oral cipro as ordered. Pt stable and will be discharged home 0n 1/19.  She came back to the hospital 1 day later.   Patient was noted to be short of breath so she was brought to the hospital.  The patient is a very poor historian due to her dementia. She states that she "does not know" to most questions.  Patient's daughter-in-law states that she does have dementia but that she has seemed more confused and has been incontinent since she was hospitalized last week.  She notes that the patient had similar symptoms while she was in the hospital.  She did have a head CT during her last hospitalization, which was unremarkable.  She has not had any recent falls.  The patient's son notes that he is concerned as the patient has been refusing to eat and drink at home and her oxygen saturation has been dropping intermittently. Discharge Diagnoses: Pneumonia due to COVID-19 virus -resolved   Hypokalemia   Encephalopathy   Dehydration   C. difficile diarrhea   Bacteremia due to Pseudomonas
Chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest congestion) 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 CHEST DISCOMFORT (Chest congestion). At the time of the report, CHEST DISCOMFORT (Chest congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
11/25/22 presents to ED for "fever". PMHx of "ESRD secondary to FSGS s/p kidney transplant 6 months ago"
This spontaneous report was received form a 64 year old female registered nurse, who was reported on herself. The patient's concurrent conditions included hypothyroidism, allergy to sulfa and penicillin. The reaction for these medications was rash and hives. On 28-DEC-2015, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included SYNTHROID. On 31-DEC-2015, the patient experienced headache, redness and tenderness at the injection site of ZOSTAVAX. The patient did not seek medical attention. No lab diagnostics studies were performed. The headache was treated with ibuprofen and resolved on an unknown date. At the time of report, the patient was still recovering from the redness and tenderness at the injection site. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
After the first dose, a few hours after when I went to bed I started itching, I did not know what was causing it, I did not take any medication. The next day I called my PCP and she told me to take Benadryl. It did help. I took it for like 2 days and I did not have any more itching. After the second vaccine I knew I had to take Benadryl before taking the vaccine. I did that for two days. In June I started getting itching again at random places. I did not have any rashes or hives. The vaccine is the only thing I could think of that was different in my life. I went to my physician, and she told me it might be scabies. She gave me treatment for scabies and the itching continued. Today I had an appointment with an allergist and they did an allergy test and patch test on my back. I do not know if this is because of the vaccine. I go back on Wednesday to see the results.
Red, warm rash around injection site. Swollen lymph node in armpit of arm where injection was given. All showed up approximately 1 week after receiving vaccine. Trated with antihystamine orally, hydrocortisone topically on injection site, and intermittent cold and warm pack on lymph node.
Two hours after receiving covid vaccine 1,  I developed a sudden flushing of face, neck, chest and a fever of 101-102.  Also weak, dizzy, nauseous, achy,  nose running clear liquid, headache throughout the night.  Fever dropped to 101 by morning then gradually went down.  All reactions diminished within  24  hours, except an ongoing headache around my eyes.  My arm where injection was administered just started to hurt 48 hours later. Treatment included Tylenol, claritin, cold drinks, cool shower, ice packs, bland diet