chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a duplicate dose of MENQUADFI, Boostrix (Tdap), and HPVwith no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 12-year-old male patient received a duplicate dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], boostrix (tdap), and hpvwith no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination; and HPV vaccine for Prophylactic vaccination.  On 12-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength: unknown) (lot: U7903AA, expiry date: 31-Dec-2025) via intramuscular route in the right deltoid for immunization.   On 06-Oct-2023 he also received a dose 2 of 0.5 ml dose of the same vaccine (lot: U7903AA) via intramuscular route in the right deltoid for immunization and patient received a duplicate dose of menquadfi, boostrix (tdap), and hpvwith no reported adverse event (extra dose administered) (latency: 24 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was unknown if any lab data/Test results available.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  Outcome: Unknown.    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 the 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.
7/27 call: C/o fever 100.8F, chills, sore throat, congestion, headache, runny nose since 7/24/21. Out on medical leave since 6/21/21. Returned from road trip, 7/24. Family member, aunt, who lives in the same household but able to isolate was tested covid positive, 7/26 resulted. EE, aunt, and husband (qmc ee, symptomatic- getting tested today) travelled to road trip together. EE fully vaccinated for covid. Advised to quarantine. Scheduled for covid testing 7/27/21 at 1740, site. EE instructed to quarantine while results are pending; however, if negative then no longer needs to quarantine.  EE will get results at mydlschart.com within 24-72 hours.  EE informed to call the hotline as soon as she gets results and at that time will get a date of when she can go to Health clinic to get a physical clearance to RTW. EE to call hotline with date of symptom resolution. EE instructed to update manager. 7/28/2021 call: Husband called to state his wife is covid positive, 7/27. She is symptomatic and currently isolating in a separate area. EE travelled to road trip 7/15-7/24. Returned on 7/24 with symptoms. EE travelled to road trip with her aunt who was also tested covid positive. Her husband, the patients is also an EE. He is symptomatic, but was tested covid negative 7/27. EE works for CTS, but is out on medical leave from 6/21/21-8/8/21. EE had breast reduction surgery. She had a breast infection that developed after the surgery and has an appt with her breast surgeon tomorrow. EE was advised to notify breast surgeon's office that she is covid pos and may need to reschedule her appt. Breast f/u appt was rescheduled for 8/5/21. Discussed with EE that she is to continue quarantine for at least 10 days and until she is asymptomatic. EE to update manager. EE to seek RTW clearance with EH clinic after DOH release and asymptomatic.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Aug2021 05:30 (Lot number: FC3180) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had been hospitalized from unknown allergic reaction" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: PYREXIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "fever"; FEELING HOT (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "felt very hot with a fever"; PAIN (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "minimal energy"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 20Aug2021 12:00, outcome "not recovered", described as "My arm where I was vaccinated, I could barely lift it up". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, feeling hot, pain, asthenia, loss of personal independence in daily activities.  Additional info :It was reported that the day after my first pfizer covid vaccination, I caught a fever, which is usually after the second dose, but after the first dose I felt very hot with a fever. Patient took vaccine at Pharmacy or Drug store and did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt presented to the MC on 4/3/08 with c/o red area on uppper right arm. Pt had received Anthrax vaccination on 4/1/08 in the afternoon. He reported feeling warm the following day. Nausea, body aches, and lethargy were also noted. Temperature 38.2 at time of ER visit, pulse 113. Diagnosed with cellulitis to the right arm at that time. Keflex 500mg q 6 hours and Tylenol 500mg 2 q 6 hours was ordered. Pt followed up the next day at the Medical Clinic, continued to c/o the above sx. MD noted a single red macule of 120mm. Diagnosed as drug toxicity vaccines, LR5 reaction localized with sx reaction to anthrax vaccine. Orders given for Triamcinolone topical 0.1% cream bid. hydroxyzine 25mg po qid prn, and Ibuprofen 800mg tid with food.
The patient was given the shot and within several minutes he became lightheaded and had a mild seizure.  This lasted approx. 3-5 minutes.
Burning and watery eyes within minutes. (similar to itching of seasonal allergies)  Fatigue, headache, upper body (head, neck, chest and back to top of rib cage) stiffness, chills starting at approx. 8:30 pm and lasting about 12 hours.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, improperly stored doses of LIQUID PEDVAXHIB lot # K015464 with expiration date 09-JUL-2017 (dose and route of administration not reported) were administered to the patients. It was reported that the vaccines underwent a temperature excursion of 34.4 degrees Fahrenheit for 8 hours. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
received the vaccine on 4/6/21 had shortness of breath on 6/8/21
Flublok Quadrivalent administered to pediatric patient/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA304970 same reporter.  This case involves a 6 years old patient (gender unknown) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.  Information on the batch number was requested.
Tightness to right side of throat. Epi pen administered. EMS called. Patient declined transport to hospital. Symptoms resolved after epi pen administration.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 04-AUG-2011 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015 the patient was treated by a physician at a medical clinic for onset of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Both doses same reaction. Extremely painful at site of injection within 4 hours. Body aches and chills within 8 hours. Flu like symptoms for 2-3 days, bad enough to postpone normal activities.
This spontaneous report as received from a physician via a company representative refers to a female patient in her late 60's. Patient's medical history and drug reactions/allergies were not provided. In 2007 the patient was vaccinated with ZOSTAVAX. Route, dose and frequency were not provided. Patient's concomitant medications were not reported. In 2007, 2 months after vaccination with ZOSTAVAX, the patient underwent a kidney transplant. The patient experienced chickenpox and encephalitis 2 months after the kidney transplant. The patient sought unspecified medical attention. No further information provided. The outcome of kidney transplant, encephalitis and chickenpox was unknown. Causality was not provided by the reported. Upon internal review the events kidney transplant and encephalitis were considered to be medically significant. Additional information has been requested.
RED,SWOLLEN, SORE "SPLOTCHES", PRIMARILY ON OPPOSITE SIDE OF BODY THAN VACCINE ADMINISTRATION
Exacerbation of asthma symptoms- cough, wheezing & shortness of breath, significant enough to require a physician visit (3/16/2021) and an emergency room visit the following day. Completed a 5 day course of oral steroids (20mg/day) and then an additional 7 days of oral steroids (medrol dose pack). Missed 6 days of work.
blood pressure went up again; feeling unwell; face got warm; throat felt dry; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell), FLUSHING (face got warm), DRY THROAT (throat felt dry) and HYPERTENSION (blood pressure went up again) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (feeling unwell), FLUSHING (face got warm) and DRY THROAT (throat felt dry). On 24-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up again). On 23-Mar-2021, MALAISE (feeling unwell), FLUSHING (face got warm) and DRY THROAT (throat felt dry) had resolved. On 24-Mar-2021, HYPERTENSION (blood pressure went up again) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: 150/100 mmHg High.     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 information was reported.
Patient had trouble breathing. Patient was given oxygen approximately 10-15 minutes after vaccine, Benadryl, Symbicort (patients own inhaler), Metoprolol (patients own) and hydroxyzine (patients own, for anxiety), O2 sats and blood pressure were monitored while patient received oxygen. Patient felt better after about 20-25 minutes after injection. Patient went home with instructions to monitor blood pressure with him home blood pressure monitor and to go to the ER if he felt worse.
she got the Delta Variant on 01AUG2021; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Bladder discomfort. Concomitant products included LEVOTHYROXINE, LOSARTAN and ROSUVASTATIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient  reported that she got the Delta Variant on 01-AUG-2021, after that she got an anti-body infusion.
passed out; can't walk very well without assistance; Sleepy; Very weak; headache; In appropriate doses interval, more than 35 days; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Taking asthma medication as concomitant).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days). On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Computerised tomogram: (Negative) negative. On 23-Apr-2021, X-ray: (Negative) negative.         No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient's heart was checked but no abnormal results. Company comment: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. states that after receiving the 1st dose of Moderna 04/09/2021, started experiencing symptoms 04/21/2021 of left arm pain, right arm pain and numbness (Paralysis). Emergency Room visit 04/21/2021, Diagnosed with Rhasbdomyolysis admitted to 04/21/2021 lasting 7 days . Transported 04/29/2021 to Private Nursing Facility Discharged after 6 weeks 06/09/2021. Currently experiencing hair loss, and mild urinary incontinence. Hospitalized for 42 days for Rehabilitation and 7 days in ICU.
PT 55 YOLD female @11:26am c/o face tightness, numbness of lips, sharp pain to tongue and chest discomfort 30mins after recving the vaccine. NP on site assessed the PT Ep1013 admin to left thigh, EMS also onsite BP 19/85 HR 96, RR 22. After epi admins PT stated that symptoms improved but still felt some mild tightness to nose area. PT denies any claudication SOB, but reported headache after recing epi. PT educated on the importance of going tp the ER for further evaluation but pt refused but verbalized that she understood the risk. PT signed AMA and NP as witness. PT reassessed and determined to be stable.
Patient presented to the ED and was subsequently hospitalized on 3/18/21 with atrial fibrillation. On 4/1/21 patient had their second dose of Moderna. On 4/9/21 patient was hospitalized for paroxysmal atrial fibrillation. On 4/12/21 Patient presented to the ED and was subsequently hospitalized again for atrial fibrillation. On 4/18/21 Patient presented to the ED and was subsequently hospitalized for acute cystitis. These visits were all within 6 weeks of receiving COVID vaccinations.
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
"very dark red, big, angry rash" on the back of both of his hands that is moving up his arms, which the caller describes as "erythema multiform"; This is a spontaneous report from contactable consumers (one is the caregiver). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 23Feb2021 (at the age of 82-year-old) at single dose for COVID-19 immunization. Medical history included cancer, stage 4 renal cancer with metastasis to the lung, kidney failure and being dialyzed, electrolyte imbalance, prostate infection, blood pressure abnormal. Concomitant medications included prednisone for kidney failure; sevelamer carbonate (RENVELA) to regulates his electrolytes; hydralazine (HYDRALAZINE) for blood pressure; candesartan for blood pressure; metoprolol succinate (TOPROL) for blood pressure; finasteride for prostate; and amlodipine. The patient developed a very dark red, big, angry rash on the back of both of his hands that is moving up his arms (reported as worsened), which the consumer describes as "erythema multiforme".  Looks like erythema multiform is this rash associated with the product very dark red, big angry splotches very large. He was told he should get the vaccination, his oncologist and his nephrologist said he should get it so he got the vaccination last Tuesday and then he woke up either the next day or the day after that and her mother said he had a very severe rash on his hands and now it is climbing up his arms. It almost looks like erythema multiforme but it has no bulls eye, It is dark red and ugly looking it is rough, it is not really raised. They went to the oncologist and they took blood work to make sure his platelets were okay and they were normal so his doctors are baffled with this. She is calling from her husband's surgery office and they are disgusted with the healthcare he is receiving there but she wants to know if there is any data with cancer patients taking the vaccine or with people that have developed a rash like she is describing. His weight has dropped a lot since she last saw him he is 5'10", now he is probably about 150 or 160 lbs. That is an estimate. He developed the rash either 24Feb2021 or 25Feb2021, she is not sure which. It was ongoing and it is actually spreading up his arms so she would say it is worsened. He is on a slew of medications, but she doesn't know if they want all of them. It could be an interaction with medication, he is a really sick person. The outcome of the event was not recovered.  Information on lot number/batch number has been requested.
(Purpura) Rash to her bilateral lower extremities. States that she first noticed it 4 days ago, and it has improved since she first noticed it but is causing her pain.  Feels as if her legs are swollen, the rash is not itchy.  It is slightly painful to the touch.