chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever 119; i got a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERPYREXIA (fever 119) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERPYREXIA (fever 119) (seriousness criterion medically significant) and PYREXIA (i got a fever). At the time of the report, HYPERPYREXIA (fever 119) and PYREXIA (i got a fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 119 (High) high and 98.6 (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.  Company comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Hyperpyrexia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Hyperpyrexia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Bursitis; A spontaneous report  was received from a pharmacist, concerning a male patient who received Moderna's COVID-19 vaccine and experienced bursitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On, an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot# 025J20A) for prophylaxis of COVID-19 infection.     On, 31 Dec 2020, the reporter stated that one of their vaccine participants was known to have bursitis. Treatment for the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, bursitis, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pt recvd Engerix-B approx 4SEP92 & 19-20SEP92 weekend had heart attack poss premature ventricular contraction; seen by MD adm to hosp on late Saturday evening 19SEP92; early Sunday morning was in cardiac failure;
Tinnitus.  A constant ringing/buzzing in head that has lasted from the initial vaccine.  I have not sought treatment but am convinced it was from the vaccine as the symptom began the same night of administration.
This spontaneous report as received from a consumer refers to an 85 year old female patient who had shingles for a while. On an unknown date recently, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength were unknown) dose/frequency was reported as "1 single shote", which made the shingles worse. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected as reporter's demographics was unknown.
Rash around the injection site approximately 3 inches in diameter although not a complete circle; Red bumps; Slightly itchy; Immediately sore arm at the injection site; Immediately swelling at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Immediately sore arm at the injection site), VACCINATION SITE SWELLING (Immediately swelling at the injection site), VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle), RASH ERYTHEMATOUS (Red bumps) and PRURITUS (Slightly itchy) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 MYALGIA (Immediately sore arm at the injection site) and VACCINATION SITE SWELLING (Immediately swelling at the injection site). On 14-May-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle), RASH ERYTHEMATOUS (Red bumps) and PRURITUS (Slightly itchy). On 10-May-2021, MYALGIA (Immediately sore arm at the injection site) and VACCINATION SITE SWELLING (Immediately swelling at the injection site) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle) and RASH ERYTHEMATOUS (Red bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medication information were provided   Reporter did not allow further contact
Injection site pain/discomfort Narrative: From 12/17/20 COVID-19 Screen note at23:06, vet reported some discomfort to right upper arm (where received vaccine) but that the pain was "ok". No additional pain reported in subsequent notes.
2 days later numbness in hands and feet and arm. Then 2 days also 102 temp. and then SOB. Put on steroids and inhalers. Same thing happened in Sept 2011.
Headache, feverish (chills, sweats, aches), soar throat, clogged ears, inflammation of left arm including shoulder (left hand most recent bout of CRPS), nauseous, extreme fatigue. Ibuprofen 800 mg which isn't helping
Breakthrough case admission after 5 vaccines Pfizer 2/23/21 Lot# El9267;  Pfizer 3/16/21 Lot# EN6205;  Pfizer 12/14/21 Lot# FD7218;  Moderna 4/21/22  Lot# 042J21A;  Moderna 9/23/22 Lot# AS7146B
Received flu shot around 10:30 am on 10/26/06; by 9:00 am the next morning, had migraine headache.  Pain in headaches increased; called doctor and received pain medication and prescription for Imitrex.
(L) thigh erythematous w/ clearing patches esp. on lateral aspect. Borders are not well demarcated. Interval clearing (+) point of entry. (-) tender to palpation.
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L013202, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however, no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Requiring hospitalization for positive covid infection.  87-year-old male history of coronary artery disease with coronary stent placement who presents with complaint of cough and shortness of breath.  She recently took a home test and tested positive for Covid.  Patient notes cough, shortness of breath.  Patient also notes malaise and fatigue.  Patient severely hard of hearing this history difficult to obtain.  Currently denies any pain.  No chest pain or palpitations.  No headache or acute visual change.  No abdominal pain nausea and vomiting.  Reactive fever, no chills or rigors.  Patient has no other concerns.  Patient notes she was double vaccinated in February.  Patient to be admitted for further evaluation.
Patient received 1st dose of  COVID-19 vaccine on February 17, 2021 . Patient received 2nd dose of  COVID-19 Vaccine on March 24, 2021.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M044399 with expiration date of 25-JUN-2018 (doses were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005827: US-009507513-1708USA005891.
Pt. received IM Flu vaccine in a.m. At 1340, service member returned to clinic area stating his throat felt swollen and he "didn't feel well". Arm red from elbow to shoulder on left side. T- 99.6F, P- 102, R- 20, B/P- 152/80 @ 1340. EPIPEN administered. VS 95 min. until hospital transport.
Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613), on 09Apr2021 as dose 2, single (Lot number: EW0158) and on 08Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01May2022 as dose 1, single (Lot number: 004M21A) for covid-19 immunisation. The patient's relevant medical history included: "slightly overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan; Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan; Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) positive, notes: Tested positive for Covid on 11Jun2022; (Jun2022) positive, notes: Tested positive again on Jun2022; (20Jun2022) negative, notes: Tested negative on 20Jun2022. Therapeutic measures were taken as a result of covid-19.  Clinical information: Tested positive for Covid on 11Jun2022. Started Paxlovid on 12Jun2022. Tested negative on 20Jun2022. Right after that, started having sore throat and congestion. Tested positive again on Jun2022. The action taken for MODERNA COVID-19 VACCINE was not applicable.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious), outcome "unknown" and all described as "a friend of her also developed pain in the elbows and also inflammation in her wrists". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine manufactured expiration date was 8/31/22. Vaccine was administered to patient on 9/23/22 after expiration date. No adverse reaction was reported by the patient.
Ringing in the ears that still continues.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications with in two weeks of the COVID-19 vaccination. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. One week after the vaccination, on 16Apr2021 at 00:00, the patient experienced ringing in his ears that still continued at the time of this report. The patient reported that he never had tinnitus in his life and now he had constant ringing in his ears. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event ringing in ears that still continued was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): via regulatory authority. This follow-up report is being submitted to amend previously reported information: Amendment of Reporter data as Reporter's post code (withheld) amended and event data as Treatment: No added for event and Narrative information as "The patient had no allergies to medications, food, or other products" amended and "The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.".
Profound myalgia upper extremities. Myositis. Several days after injection reaction at 6 wks post.
4 days later have no range of motion in right shoulder, cannot lift my right arm and weakness in right arm, some numbness in shoulder and radiating down arm. Ibuprofen and ice are not helping. Injection was given much higher this time than the first dose.  I?m stretching it frequently but haven?t noticed it helping. It feels like a frozen shoulder.
Urinary tract infection; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown demographics) who experienced urinary tract infection after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious urinary tract infection (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Never will. Last time I got a urinary tract infection (U.T.I.)".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX, subcutaneously, which had lot # M009764, with 23-FEB-2018, lot # L048462 with expiry: 02-DEC-2017 and M012990 with expiry: 14-MAR-2018 (dosing details not reported). No adverse effects reported. No further information reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Had sharp pain at arm; muscle spasm, sweats, involuntary muscle spasm,causing motor vehicle accident.
Body aches evening after vaccine. Nausea starting 8 am next day , all day.
01/08/21: Fatigue in the evening (no specific time given) 01/09/21: around noon trunk of body felt like it was in a vice squeezing, headache, nausea, sore throat, chills, and extreme fatigue that lasted a solid 5 hours. Patient reports taking 2 tablets of 200mg ibuprofen and symptoms eased up leaving her extremely tired.  Patient reports taking 2 650mg tablets of acetaminophen around noon with no relief. 01/10/21: soreness in the arm of the injection 01/11/21: fatigue, body cramps (occasionally) decreased appetite, numbness in arm of injection
pt had sudden cardiopulmonary arrest 3AUG96 while rollerblading;it was unclear whether his fall caused the death or whether another event triggered the fall;pt failed to respond to resuscitative efforts & died;
12MAR92 lt arm began getting red & by 16MAR92 arm was swollen & red from deltoid inject site down to the elbow; c/o soreness, arm felt warm to touch; fever (temp not taken) dx staph infect given ATB;
Mild tenderness at injection site, still present today, getting less each day (27 MAR).  Fatigue on the 25th and 26th; same sensation I get when sick with cold or flu, only with no fever and no aches.  Felt fine morning of the 27th.
This spontaneous report as received from a female consumer of unknown age and refers to herself. On an unknown date (reported as several years ago) the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot # and expiration date not provided). On unspecified date the patient developed little fluid filled blisters on buttocks that itched, burned and hurt. The patient was treated with unspecified antibiotic. It was reported that patient did not seek medical attention. The outcome of the events was unknown. Relatedness between events and ZOSTAVAX was not reported. Additional information is not expected, no reporter's contact details were provided.
- Swelling in upper arm down to elbow - stiffness - some pain - some sweating/nausea
Patient's arm became red, swollen, hot, and painful the night of the vaccination. She did not sleep well. She was sitting in a chair when her daughter found her passed out. She stated she had been unresponsive for 9 min. The daughter called 911. They gave her fluids, ran tests, EKG, BP (found to be high), Glucose (found to be low), CAT scan, blood tests. No stroke resulted. They went to see her primary care doctor, and he stated that because she had not eating anything, and only weighs 90 lbs, and combination of bad sleep and vaccination, she passed out.
Information has been received from a health professional concerning a male who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine (+) rubella virus vaccine. On 03-MAR-2006 the patient came into the health center with parotid swelling. It was noted that the patient's father was a physician and was going to draw labs on him. Additional information has been requested.
Patient is a 82 y.o. female patient of CNP with history of CAD (s/p PCI), CKD3, HTN, HLD, hypothyroidism, GERD  presented with SOB and confusion.   Acute hypoxic respiratory failure  Severe sepsis due to COVID pneumonia, can not rule out Bacterial pneumonia P/w confusion, shortness of breath, generalized weakness at assisted living facility. Now all resolved and pt back to baseline and upbeat (probably steroids helping) Afebrile on arrival but hypotension and tachycardia noted, associated with tachypnea and leukocytosis. Now improved, mild tachycardia with activity Initially hypoxemic requiring 4L NC O2, now weaned to room air WBC 28 on adm, now improving but persistent due to steroids.  CRP 132, lactic ac nl.  COVID positive 8/23/22. Pt was vaccinated, has not gotten booster CXR: New ill-defined opacities in the right mid lung, which are concerning for a pneumonia. Fluids given  Given Vanc and zosyn in the ED, change zosyn to cefepime, de-escalate to omnicef at discharge Decadron 6mg daily for 10 days  No Remdesivir due to AKI Blood Cx. strep/legionella Ag negative Encourage IS/PEP    Acute metabolic encephalopathy, resolved.  Initially confused on admission, most probably due to sepsis, hypotension and hypoxia, now resolved.  Cont supportive care   Acute kidney injury on CKDIII Hyponatremia/ Hyperkalemia Initial Cr 2.35 (baseline ~around 1.1). Now improving, down to 1.7 Likely pre-renal in setting of severe sepsis UA nl Na 133/  K 5.2, monitor Avoid nephrotoxic agents, renally adjust meds as indicated   Chronic normocytic anemia No e/o bleeding, Likely ACD.  Hgb ~9 near previous baseline Previous Iron panel and retic suggest ACD Previous B12/folate wnl  Daily CBCs  CAD s/p remote PCI HTN, HLD Holding home BP meds Cont home plavix, statin   Moderate PAD Chronic pain sydrome Hold tramadol  Cont gabapentin Doxycycline ordered by podiatrist 8/22, hold    Hypothyroidism Cont home synthroid    GERD Home PPI   Goals of care with advanced directives Patient requesting DNR-CCA, code status order updated to reflect their wishes
I was more fatigued, more than normal. Just completely exhausted. I did not get any treatment. I went to my doctor.
Received Influenza vaccine at approx 9:00AM.  Indicated approx 9:00PM (12 hours post vaccination) had severe itching of arms, greater on right than left and itching of upper abdomen.  Vaccine administered in left deltoid.  Self treated with OTC Bendadryl and symptoms resolved.
Severe headache. Joint and muscle ache. Eye pain. Chills itching. Sore arm
Information has been received from a 26 year old female who on 13-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck). The reporter stated that her last menstrual period was 01-DEC-2008 and that 3 recent at home pregnancy tests were positive. The estimated delivery date is 07-SEP-2009. No adverse effect reported. Follow-up information has been received from the patient who stated that she is going to terminate her pregnancy due to getting VARIVAX (Oka/Merck). Upon internal review elective termination of pregnancy was considered to be another medical important event. No further information is available.
Developed erythema with induration on left deltoid measuring 10.5cm X 8.5cm, tender, bruising and hot to touch. Treated with ice, cephalexin for dx of cellulitis.
Seen 8/2/03 with hypotension and fever. Diagnosed with E. coli bacteremia and Pyeconephritis.
Pt. developed fever 103.1 after receiving 2 vaccines on 3/8/10. Developed tonicoclonic convulsion next morning lasting 1 minute. First in life convulsion.