chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost his kidneys; This spontaneous case was reported by a physician and describes the occurrence of RENAL FAILURE (Lost his kidneys) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 RENAL FAILURE (Lost his kidneys) (seriousness criterion medically significant). At the time of the report, RENAL FAILURE (Lost his kidneys) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment drug was reported.  Company comment: This spontaneous case concerns a 35-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of renal failure. The event occurred on an unknown date after a dose of mRNA-1273 bivalent BA.4/BA.5 (of note vaccine type and brand was not specified). As reported, 35 year old patient lost his kidneys because of the vaccine. No further information about the events was provided. The reported was not sure if the patient received Pfizer of Moderna. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732229:Case for other people
The injection site formed a large lump the size of my hand, fever of 2.5 degrees above normal, blackened out eyesight and weakness and difficulty walking
Difficulty swallowing, uticaria HR: 88 BP: 180/112 Administered 0.3 Epi pen L thigh  Transported to ER via ambulance
Same day, after returning home, pt developed a patch of papules at anterior vastus of right leg measuring 3 cm x 2 cm, then another patch @ most lateral vastus of right thigh w/ another patch of papules 4 cm x 3 cm. According to mother, the area was much redder & warm 3 days ago and was itching. This child received another set of vaccines (IPV & MMR) into left vastus w/o any reaction. MOC applied ice pack which MOC said helped. Since MOC has triamcinolone 0.1% at home, advised application to patches bid x 1-2 weeks.
Suddenly began to shake so much that all I could do was get into a bed. I was shaking like a was very cold internally. I could not even hold my tooth brush to brush my teeth.
Raised Rash/welts/hives at injection site and down the entire left arm/forearm.Itchy, and hot arm.. started day after injection and is still ongoing now 6 days later.  Now also spreading to the right upper arm( 6 days later).   Headache beginning  directly after injection and lasting 3 days.  Extreme fatigue evening of injection and lasting foe 2.5 days
Admit to hospital on 3/25/2023 with acute hypoxic respiratory failure due to COVID-19. COVID positive 3/25/2023. Date of death 4/17/23.
3-8-21 Moderna Vaccine #1 a 3-18-21 phone call States after vaccine had fever 101 couple days-resolved. Was also very nauseated, decreased appetite. Could bearly eat anything. Had decreased urine output-improving. Now having increased shortness of breath Admitted 3-19-21 to hospital for Afib. Also ear drum ruptured. 3-24-21 Seen, continued with night sweats, chills, fatiue, shortness of breath.  4-2-21 Had abnormal Nuc Med stress test. symptomatic decompensated heart failure. TTE showed EF 65%. Transferred to another hospital. 4-3-21 discharged from Hospital 4-6-21 in ED c/o SOB at night and with activity. Pt denies N/V/cough. Pt states she feels a little bit of CP when having PVC-Admitted-Dyspnea,Tachycardia,heart failure with preserved ejection fraction,Orthostatic hypotension. Discharged 4-10-21.
p/vax pt devel redness & swelling @ inj site;area cont to swell approx 3hr;area is very painful, red & swollen;area has defined edge & measures 150mm x 120mm;referred to MD for eval;
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date in 2013 the patients might have been vaccinated with M-M-R II 0.5 ml that was improperly stored. Lot numbers were not provided. The vaccines were exposed to 47 F for 48 hours in March 2013. No adverse effect was reported. The reporter considered an unknown number of patients might have received improperly stored MMR vaccines and no adverse effect to be not related to M-M-R II. Additional information has been requested.
Post Pfizer 2 nd dose severe dizziness and cardiac issues. Later went into AFIB and now have enlarged Atria
Patient is a resident of assisted living facility.  At the place, the patient was transferred to the hospital for change in mentation.  CT of the head was negative.  Lab workup was unremarkable.  Patient was ready to be transferred back to the facility when the facility requested that we do a COVID.  The patient was tested and was positive.  Unsure if the patient is vaccinated as the patient is unable to provide any history.  Patient currently on room air, afebrile. The patient is asymptomatic.
administration of Fluzone HD in pregnant women, no advesre event; administration of Fluzone HD in 40 years old women, no advesre event; administration of Fluzone HD in 40 years old women, no advesre event; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 40 years old female patient who was pregnant and vaccinated with a 0.5 ml dose of  vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UT6681A via intramuscular route in the left deltoid on 29-Oct-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The gestation period not reported.  The date of last menstrual period was not reported. The estimated due date was unknown date of Jan-2020. The Information regarding  previous pregnancy/ies not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not revived other vaccines.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  The patient had no adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  The pregnancy outcome was not reported.
Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.
Pt's mother reported reaction on 4/7/11 & pt. evaluated at clinic on same day. S/S: rash/hives: (L) upper arm w/erythematous raised macules covering approximately 50% of lateral side; (R) upper arm w/ sml single erythematous raised macule (2x3cm). (L) knee w/warm, swollen red rash (5x5cm); some abd. pain, itchiness & burning at site; headache.
This case was reported by a physician, via a sales representative, and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The subject's medical history included human immunodeficiency virus.  On an unspecified date(s) the subject received the 1st, 2nd, and 3rd doses of Twinrix (unknown).  At an unspecified time after vaccination with Twinrix, the subject did not seroconvert.  At the time of reporting the outcome of the event was unspecified.
From initial info received on 6/3/05 from a physician regarding an adverse event occurring in the USA, it was reported that an 18 year old female pt received a dose of Menactra, lot U1588AA, IM in an unspecified site on 5/25/05. Two days later, on 5/27/05, the pt developed a rash on her face and neck. The pt was seen by a physician. Per the reporter, the pt recovered from the event.
This spontaneous report as received from a nurse refers to a 17 year old female patient, who in 1994 was vaccinated with series of RECOMBIVAX HB (lot # and doses not reported), "on school", as a child. At an unspecified time in 2013 the patient had titers drawn for Hepatitis B and the results were negative. The patient sought medical attention by consulted office. The outcome of patient and causality was not reported.  Additional information has been requested.
pt had raised pink area below inj site;area was approx 5-6in in length & almost encircled diameter of arm;area was warm but pt stated it did not hurt that much;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 at 10:00 as dose 1, single (Lot number: ER8737), in left arm, on 19Apr2021 at 14:00 as dose 2, single (Lot number: EW0164), in left arm and on 06Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible and no further information is expected.
After shot 2 my period started 2 weeks early. It was extremely heavy. After that my period came every 21 days rather than every 28 as before the shot. Again bleeding very heavy not like usual periods. After 7 months I developed a lump in my breast and was diagnosed with stage 3 triple negative breast cancer with lymph node involvement.
Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 27-Nov-2007 was vaccinated with a dose of Gardasil (lot #657736/0389U).  Concomitant vaccine therapy included diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) Menactra.  On 29-Nov-2007 the patient reported lower back pain.  At the time of this report, the patient had not recovered.  Additional information has been requested.
SORE THROAT; ANXIOUS MOOD; RASH; INFECTION VIA VACCINEE; OBSESSIVE-COMPULSIVE DISORDER; PANDAS SYMPTOMS DEVELOPED SOON AFTER SCARLET FEVER; SCARLET FEVER; FLU LIKE SYMPTOMS; Flu like symptons; A spontaneous report has been received from a consumer via the regulatory authority concerning a 5 year old male patient with height of 120 centimeters and with weight of 19 kilograms.    No medical history was reported. No concomitant products were reported.    On 11-Oct-2015, the patient was administered with Fluenz (influenza vaccine (live, attenuated)), via nasal route.     On 15-Oct-2015, the patient experienced flu like symptoms (preferred term: Influenza like illness). On 21-Oct-2015, the patient experienced scarlet fever (preferred term: Scarlet fever).   On an unknown date, the patient experienced obsessive-compulsive disorder (preferred term: Obsessive-compulsive disorder), pandas symptoms developed soon after scarlet fever (preferred term: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection), sore throat (preferred term: Oropharyngeal pain), anxious mood (preferred term: Anxiety), infection via vaccinee (preferred term: Infection via vaccinee) and rash (preferred term: Rash).     The patient recovered from the event of flu like symptoms after 6 days on 21-Oct-2015. The patient recovered with sequelae from the event of scarlet fever after 1 month on 30-Nov-2015. At the time of reporting, the event of pandas symptoms developed soon after scarlet fever was ongoing. The outcome of the events of obsessive-compulsive disorder, sore throat, anxious mood, rash and infection via vaccinee was unknown.     The events were considered serious (disability and important medical event) by the reporter.; Sender's Comments: Obsessive-compulsive disorder (OCD), Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS), Influenza like illness, Scarlet fever, Oropharyngeal pain, Anxiety, Infection via vaccinee are not listed events in the company core data sheet for Fluenz Tetra. Young age and Infection via vaccinee could be a risk factor for scarlet fever, which could explain the development of influenza like illness with oropharyngeal pain and the development of PANDAS with subsequent OCD and anxiety. Due to missing information on more details of the Infection via vaccinee, complete etiologic and diagnostic workup, medical history, comorbidities and concomitant drugs it is not possible to make a conclusive assessment of the causal relationship of Infection via vaccinee and suspect drug.
Stomach rolling, belching, diarrhea on 6/14/08. Went to Dr. on 6/16/08
5 days after flu shot: fever 101+ for 14 days; severe inflammatory headache for 8 days.
The pt experienced an onset of painful, pruritic rash in L2 dermatome of right leg, with vesicular eruption. No systemic symptoms. No known wild type varicella contact.
- headache began at 10 pm on 10/12/20 - 10/13  developed 102.3 f fever, chills, dizziness, left deltoid redness, swelling, warmth, pain, headache - 10/15 continues to have headache and fatigue and left arm pain/redness/swelling but no fever. no history of prior vaccine reaction
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 22-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. Tran date was reported as 23-Mar-2022. It was reported that , the patient did not have any adverse events post injection. Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. Excursion occurred on 10-Apr-2022. No information on treatment medications was reported.
The patient was advised to go to ER due to nerve pain in her face. She was prescribed gabapentin and VALTREX.
Redness and swelling at injection site; redness progressed down arm below injection site; warm to touch.
mom calling by phone stating pt's leg, where recvd shot on Tuesday, is swollen-greater than half dollar & red & is blistered like & leaking clear fluid; also had a rash yesterday but is gone today; pt saw MD 20JUL95-localized rxn;
Pt scheduled for UC covid vaccine, MA went into room patient advised her this was his first vaccine, she went through questionnaire with patient, and administered the vaccine. Upon documenting in Epic she found he had already received Moderna series 2/6/21 and 3/6/21. She went back into room pt told her he was immunocompromised and its ok if he gets three shots. Provider informed. Patient received 3 total doses.
ADMINISTERED WHOLE VIAL; FELT A LITTLE TIRED; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805020) 2.5 ml, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced administered whole vial. On an unspecified date, the subject experienced felt a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt a little tired, and the outcome of administered whole vial was not reported. This report was non-serious.  Additional information was received from pharmacist on 17-Mar-2021 following information was updated and incorporated into case narrative: Patient demographic details (age, sex), covid-19 vaccine ad26.cov2.s therapy details (batch number, dose), additional event of felt a little tired, reporter details and other identification numbers was added.  Additional information was received on 19-Mar-2021 following information was updated and incorporated into case narrative:  The case is associated with product quality complaint number 90000173653.  Upon review, the following information was amended: Route of administration corrected, pre-existing medical condition removed, outcome and event rank corrected.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
mettallic taste in mouth; mettalic/burning smell; Rash; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) intramuscular on 01Apr2021 at 07:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history, family history, and concomitant medications were none. The patient did not receive any prior vaccinations (as reported). On 02Apr2021 at 08:00 the patient experienced rash. The event was reported as non-serious. On unknown dates the patient experienced metallic taste in mouth and metallic/burning smell. The events were reported as serious (persistent/significant disability/incapacity). The patient had a constant burning smell/taste. Sweet foods were okay, but any other foods such as meat and vegetarian tasted like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she could not determine chemical potency. The patient did not receive any treatment for the events. The outcome of rash was recovered on 30Apr2021. The outcomes of metallic taste and smell were not recovered. It was also reported that the patient received dose 2 of BNT162B2.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100943663 same patient, different dose/events
ARM SORE, RED SWOLLEN AT INJECTION SITE, JAW SORE, BODY ACHES.
Pt presented to ER with severe (10/10) R arm pain in afternoon. Received SHINGRIX at approx 1200. Within 30 minutes reports ahing in R arm. After 1 hour, reports severe pain. Pt treated with several meds before pain was relieved.
somewhat sore; Tenderness; Pain left armpit; slight swelling; This is a spontaneous report from a contactable consumer, the patient. A 51-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 left arm on 08May2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. On 09May2021 at 19:00 the patient experienced tenderness, pain left armpit, and slight swelling. On 12May2021, 4 days later, the patient stated still somewhat sore not a major concern. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tenderness, pain left armpit, slight swelling and somewhat sore was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
DEATH Narrative:  LIMITED INFORMATION PROVIDED IN MEDICAL RECORD OTHER THAN SON CALLED TO REPORT PATIENT HAD BEEN TRANSFERRED OUT OF ICU TO HOSPICE CARE ON 03/02/21. No documentation regarding hospital admission or ICU care. Son called on 3/3/21 to report patient passed away peacefully and without pain. No previous COVID infection, no recent hospitalizations known, no immediate acute reaction to COVID vaccine. Unlikely that vaccine contributed to death, as patient was on hospice with advanced age of 91 years.
pt had shingles dx 2MAY98-never had actual case of varicella-for your info only;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that an improperly stored M-M-R II was administered (0.5 ml, subcutaneously, lot# not reported) on an unknown date. The nurse stated that the vaccine reached a temperature of 39.2F for 6 hours. She also stated that was a "possibility" that M-M-R II reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if the M-M-R II did reach to 59.4F and give the national service center a callback. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA002487 and with MARRS# 1405USA002848 via same reporter. Additional information has been requested.