chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began with chest pain on 9/5/21. From 9/6/21 to 9/13/21, I had 102 fevers every night, chest pain, chills, headaches, and night sweats. Visted urgent care twice.  First time was given Z pack and chest xray. Symptoms did not improve. Visited second time and had flu test, strep, urine analysis; all negative/normal. Saw primary care doctor on 9/17/21 and had d- dimer blood test that was 2, so was sent to ER on suspicion of blood clot. No blood clot, but CT scan found a large mass/enlarged lymph node near my chest. Was told it could be cancer and was admitted to hospital on 9/17/21. Discharged 9/18/21. Pulmonologist suspected it was a fungal infection, not cancer. Had bronchoscopy done on 9/21/21. Blood tests are showing histoplasmosis or blastomycosis so far, but not all results are back yet. Now on anti-fungal medication, Itraconazole.
Diffuse macular papillor rash; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 13Jan2021 (Lot Number: EL1284) (at the age of 35-years-old) as single for COVID-19 immunization in the hospital. Medical history included diabetes mellitus and penicillin allergy. Concomitant medications included metformin, sertraline and propranolol taken for an unspecified indication, start and stop dates were not reported. the patient did not take other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on 23Dec2020 at 07:00 (Lot Number: EH9899) for COVID-19 immunization. The patient has not underwent COVID prior to vaccination and has not been tested since the vaccination. The patient experienced diffuse macular papillor rash on 06Feb2021 08:00. The adverse event was treated with Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
per patient, next day had huge red swollen area on arm, that was red, swollen and hot to touch. She also had a migraine in the back of the head that only went away when she laid down
COVID arm (Swollen- she couldn't move it), fever, general malaise, thyroid storm (loss of appetite, general malaise, heart racing, SOB) -She was taken to ED because her symptoms kept getting worse. She was found to have an abnormal EKG - " Afib with rapid ventricular response..."
two patients were tested positive for COVID-19 infection/one patient before receiving the second dose; two patients were tested positive for COVID-19 infection/one patient before receiving the second dose; This is a literature report.  A 15 year-old (range 12 -18-year-old) patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Post-transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "two patients were tested positive for COVID-19 infection/one patient before receiving the second dose". The patient underwent the following laboratory tests and procedures: antibody test: unknown results; sars-cov-2 antibody test: unknown result; sars-cov-2 test: positive.  Additional information: In a study, assessing the effectiveness of Pfizer in 12 -18-year-old adolescents, among 57 participants, only two patients were tested positive for COVID-19 infection, one patient before receiving the second dose and another one 46 days after the second dose. Two patients tested positive for SARS-CoV-2 infection during the study period. The first experienced 7 days of mildly symptomatic infection not requiring hospitalization between their two vaccine doses without an available post-V1 serology.  Follow-up (26Feb2022): This is a literature report. This is a follow-up report; the case has been updated to include additional information identified in the publication. Updated information: Literature information, medical history, patient's age, vaccination date, event onset date and clinical course.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.,Linked Report(s) : PFIZER INC-202200200573 Same article/drug/event and different patient.
1hr p/vax pt reported swollen mouth & tongue;transported to hosp ER via fire rescue;
Information has been received from a registered nurse concerning a 38 year old female who on 12/27/2000 was vaccinated with her second dose of hep B vaccine recombinant IM. The pt experienced discomfort in her arm for several days. The pt was inadvertently given the hep B vaccine recombinant dialysis formulation (1 ml). The registered nurse classified the incorrect dosing as an overdose. No further information is available.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated intramuscularly with a dose of GARDASIL (0.5ml, lot # and expiration date were not reported) that underwent a temperature excursion. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Medical assistant administered 2 Moderna vaccines were the vial was punctured for the last 7days out of refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant administered 2 Moderna vaccines were the vial was punctured for the last 7days out of refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) 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 EXPIRED PRODUCT ADMINISTERED (Medical assistant administered 2 Moderna vaccines were the vial was punctured for the last 7days out of refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant administered 2 Moderna vaccines were the vial was punctured for the last 7days out of refrigerator) outcome was unknown.        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 were not provided by reporter. Treatment information was not provided by reporter.
Patient got to FLUZONE HD for the first time on 9/30/16. Since the vaccination, her (R) arm became swollen (hard), red, hot, and mildly itchy. This has been spreading in the deltoid muscle area for the last 2 days - Advised to take BENADRYL and call MD.
Patient was found unconscious and smelling salts were used. He did return to consciousness. Reported feeling nauseous and dizzy. Vital signs were taken by EMS. Escorted to ambulance for observation, vital signs were retaken. Decision was made to transport to ED.
7 days, post vax, she developed hives and continued to break out for over 2 weeks. Hives appeared on face, arms and legs. Her physician has given a medical examination to future Hep-B vaccines.
This spontaneous report as received from a pharmacist refers to a 69 year old, non pregnant female patient with drug allergies including penicillin, neomycin, sulfa and ZITHROMAX. The patient had no concurrent conditions and pertinent medical history. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX lot # L028281, expiration date 28-OCT-2016, 0.65 ml, subcutaneous. On 07-NOV-2015, the patient developed "itching, warmth, redness, pain extending into her armpit and firmness to the touch" at the injection site. No lab diagnostic studies were performed. No treatment was given due to events. On 09-NOV-2015, the patient returned to the pharmacy to inquire about the adverse effects. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Patient said she got very hot and did not feel good.  Her neck and face got red like she was breaking out in hives. She was ok 2 minutes later after a dose of Benadryl
1/19/21 evening, the same day the vaccine was given, symptoms occurred 6 hours after vaccinated: diarrhea, stomach cramps, no appetite, low energy, soup diet only for 4 days. 1/24/21, symptoms improved and had soft solid food about 6pm. Around 7:30pm, strong stomach cramps and bad diarrhea. Sitting on toilet, the pain getting stronger and started chill and quick cold sweat on forehead and whole body, feeling numbness spreading in skin, foggy in brain and vision, and difficult breath.  Stood up unbalanced and vomited badly. I could not remember the order of vomiting and calling 911. While calling 911, breath became harder. Laid down about 10 minutes, breath came back a little bit when ambulance arrived, lips blue.  Oxygen was given and BP was high on the way to ER. Vital signs were normal upon arriving ER. IV fluid and medications were given for diarrhea and stomach pain. BP and all lab work came back normal. Continued diarrhea for a few hours and was discharged about 1:30am 1/25/21.              Diagnose: unknown reason diarrhea Stomach pain and discomfort continued a few weeks.                     Did not take 2nd dose. Covid19 Antibody test came out negative 3 weeks later.   Can I take Novavax if it gets approved?
Tingling in arms, legs & hands;weakness in lt hand, leg weakness, muscle spasms in legs lasted from 7JUn-31JUL;some tingling & pain in hands & legs cont, but much milder;poss benign MS;
Fever and chills for 5 hours over night, subsided on own. Concurrent with body aches and headache that has not subsided. 400 mg ibuprofen has little effect on headache.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-SEP-216, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # K011188, expiration: date 12-AUG-2016 (dose, route of administration, were not reported). The nurse reported that the patient received a properly stored, expired dose of (wistar ra 27-3) M-M-R II. There was no product quality complain (PQC) involved. There was no adverse event reported. Additional information has been requested.
Lt leg swelling 12MN p/pain 6hrs later; erythema 18 hrs p/;
(4/1) - Local reaction about 2" in diameter where VCZ given on arm - red, swollen lump, tender, hot to touch.  Increased to 3" by next day, (4/2).  4/4 redness, tenderness decreased, but lump still there.
Patient received  his Janseen vaccine approx. at 10:50 AM; he was in the waiting area and had (2) witnessed small seizures.  Small abrasion to right backside of the head (slight bleeding/no swelling).  In between seizures was alert and oriented able to answer all questions.  911 was called, wife was called arrived on scene.  He was transported to the hospital for further observation.  His vitals were stable when transported.
-- c/o: rash  started about 2 weeks ago.... Received her booster vaccine for COVID..Pfizer Recieved booster Moderna 1/2 dose 11/23/21...rash started on 11/25/21  started on neck with one scaling patch then spread getting worse mildly itchy now on anterior chest forehead and scalp no fevers no breathing or swalloing issues  has not tried anything on this  nothing new ie detergents, lotions etc
Child has a 6cm x 3cm erythematous rash on her (R) upper anterior thigh Laterally & anteriorly is the injection site.
DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series 1, 1 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died (Dose number in series 1). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from unknown cause of death. This report was serious (Death).; Sender's Comments: V0: 20211264458-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Atrial fibrillation; Cold body temperature especially in the feet; fast heart rate; dizziness; A spontaneous report was received from a consumer regarding her husband, an 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fast heart rate/heart rate increased, cold body temperature/coldness, dizziness and atrial fibrillation.   The patient's medical history was not included. Concomitant medications were not reported.  On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 06 Feb 2021, approximately 10 days after the patient received the vaccine, he experienced a fast heart rate, dizziness, cold body temperature, and atrial fibrillation. (The wife reports that they purchased an EKG machine, and this is what the machine showed them. Unaware if he had this before the vaccine or not.)  Treatment information was not provided.   Action taken with mRNA-1273 was unknown.  The outcome of the events, fast heart rate, cold body temperature, dizziness and atrial fibrillation, was unknown.; Reporter's Comments: Although a temporal association exist, the event occurred 9 days after vaccine administration and very limited information regarding this patient's medical history concomitant medications were event is also confounded by the patient's advanced age.  Further information has been requested.
POSSIBLE BLOOD CLOT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter stated that on an unspecified date, the patient experienced possible blood clot but unsure if that was before or after the vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211115081, 20211115400 and 20211115414.; Sender's Comments: V0: 20211115315-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt recvd 1 dose of Engerix-B & w/in hrs devel extreme stomach cramps, felt very ill, had pain in eyes, had to avoid light & had nausea & vomiting;
3" circumference, reddened area, warm, pruritic noticed guestimate 24 hours after receiving injection. PCP office notified 48 hours, pt to receive ibuprofen (100mg/5ml) 1/2 tsp every 6-8 hours prn, Benadryl (12.5mg/5ml 1 tsp every 6 hours prn. No fever noted, local reaction observed by mom.
Vomiting; Fever; Body aches; Headache; Painful injection site; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ew01), via an unspecified route of administration in arm left on 30Jun2021 at 11:00 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included COVID-19 from an unknown date and unknown if ongoing. The concomitant medications of the patient included lorazepam (LORAZEPAM), lithium (LITHIUM), quetiapine (QUETIAPINE) and one a day multi start date and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Since the vaccination, the patient not been tested with covid-19. On 30Jun2021 the patient experienced vomiting, fever, body aches, headache, painful injection site. The outcome of the events was reported as unknown.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Had the Moderna vaccine, came down with COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had the Moderna vaccine, came down with COVID) in a male patient of an unknown age 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 an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had the Moderna vaccine, came down with COVID). At the time of the report, COVID-19 (Had the Moderna vaccine, came down with COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant product was reported.  The patient had the 2 shots and 2 boosters, total of 4 doses. The patient was going to get the 3rd booster but become positive before getting 3rd booster.  No treatment product reported
red hot area on arm where vaccine was administered. it was large and traveling so i recommended she get checked out
Patient had Heplisav 10/03/23. Patient was due for second injection but was given Engerix instead. Manufacturer contacted and advised patient should have a third dose of Hep-B vaccine.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/2021 2nd dose01/06/21 Diagnosed covid positive:09/02/21 Symptom onset:08/31/21 Exposure: Symptoms:fatigue,cough,runny nose,HA
BOWEL URGENCY; This solicited report received from a patient via RRA-18356: Nurse Navigators from Janssen program for STELARA Crohns concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included hand surgery. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose and frequency were not reported from 15-MAR-2021 for an unspecified indication. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the patient experienced bowel urgency. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of bowel urgency was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and bowel urgency as possible; and between ustekinumab, and bowel urgency as possible.  This report was non-serious.
Patient received his second Pfizer dose under observation in our office on 10/21/21. Pt premedicated with Prednisone 50mg at hour 13, 7 and 1 before he received the Pfizer vaccine in our office. He also took Zyrtec 10mg about 20 minutes before receiving his vaccine. He required epinephrine in our office shortly after receiving the vaccine. See below for timeline of events: Baseline vitals: P 111, SpO2 98%, RR 20, T 99.1 F  1. 10:17a - Pfizer dose given. 2. 10:20a - Within 3 minutes of receiving the Pfizer vaccine he noticed the same sensation in his throat (swelling & difficulty swallowing) that he experienced with his first dose of Pfizer. Dr.  notified. 3. 10:26a ? Dr. gave epinephrine 0.3mg IM and listened to his lungs (clear to auscultation). SpO2 = 97%, Pulse 115, RR 22. 4. 10:30a ? SpO2 = 97%, Pulse 118, RR 22. Pt felt a sensation in his throat now in the clavicle area. He took a sip of water and had some more difficulty swallowing it.  5. 10:35a - SpO2 = 97%, Pulse 115, RR 22. Sensation in clavicle area now improved, water slightly easier to swallow. 6.  10:40a ? BP 158/84, SpO2 = 97%, Pulse 118, RR 22. Sensation in his clavicle area/throat now feels worse. He had some more difficulty swallowing water. 7. 10:50a - BP 142/80, SpO2 = 97%, Pulse 122, RR 22. Sensation in clavicle area/throat and difficulty swallowing water are all the same as previously stated. Gave liquid Zyrtec 10mg.  8. 11:10a - BP 142/70, SpO2 = 98%, Pulse 114, RR 20. Sensation in throat slightly improved.  9. 11:30a - BP 134/78, SpO2 = 98%, Pulse 110, RR 20, T 98.4 F. Sensation in throat slightly improved.  10. 11:54a - BP 122/86, SpO2 = 98%, Pulse 105, RR 20. No changes. 11. 12:15p ? BP 126/84, SpO2 = 98%, Pulse 107, RR 20. Pt walked to the bathroom, a little lightheaded, but it improved after standing and walking around. Throat sensation mostly improved and Dr. OK?d him to leave. He had two epi pens with him and instructed to use it if throat symptoms worsen, then call 911.
several pt recv vax & devel inj site rxn characterized by redness, swelling & pain;