chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient passed away; patient was administered from an expired vaccine /misadministration; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (patient passed away) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  it was reported that the dose administered was after 30-day use by date or after manufacturer date of expiry. 50 expired vaccine doses were administered to patients and staff. Date the vial was initially stored in the refrigerator: 04-Nov-2021. Date(s) of administration of vaccine was reported as some 05-Nov-2021 and the other doses on 12-Nov-2021. Vial did not undergo any temperature excursions.  No adverse event was reported  as a result of this misadministration, patients were monitored.  Company comment: This is a case of Expired product administered for this 77-year-old male patient, with no medical history reported, who died after the administration of a dose of mRNA-1273 vaccine. It was reported that vaccine was administered after 30-day Use By Date or after manufacturer date of expiry. The patient received a dose in November 2021, he died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time, further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-501813 (Patient Link).; Sender's Comments: This is a case of Expired product administered for this 77-year-old male patient, with no medical history reported, who died after the administration of a dose of mRNA-1273 vaccine. It was reported that vaccine was administered after 30-day Use By Date or after manufacturer date of expiry. The patient received a dose in November 2021, he died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time, further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown
Info has been received from an NP concerning a 32 year old female who was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, the pt "was not shown to be immune to the components based on a drawn titer". Unspecified medical attention was sought. No product complaint involved. Additional info has been requested.
Patient was vaccinated with the varicella (chickenpox) vaccine when she was a little over one month old and she seemed to be ok. Earlier this month, she developed a bad case of shingles on her right thigh that required a visit to a doctor. I thought that you could only get shingles if you had had chickepox before and my daughter has never had chickenpox ever or even been exposed to it. That is because the virus stays in the body. But, we went to the doctor earlier this month when she broke out with shingles. He said that the vaccine introduces weakened virus into body and that had apparently "awakened" like it would with a natural infection. I really wish that we had been told about this before we allowed our daughter to be vaccinated. Other parents and caregivers as well as the public in general needs to know about this. She is doing a little better now.
Severe hives starting about 1.5 days after vaccination. Severe hives covered all of body. This continued for 2 days and are being treated with prednisolone SOD Phos 15mg/5ML for 5 days. Diphenhydramine HCL 12.5 mg oral solution Antihistamine dosed at 25 mg every 6 hours on first day and twice on second day. Headache and soar throat for 2 days accompanied hives. Severity of hives decreased but are continuing into today 09/26/2021. Sore throat is also continuing into today.
This spontaneous report as received from a medical assistant refers to a 26 year old male patient. There was no pertinent medical history and drug reactions or allergies provided. On 04-DEC-2014 the patient was vaccinated with a dose of expired (Oka/Merck) VARIVAX lot # H020587, expiration date 13-NOV-2014, 0.5 ml, subcutaneous. No concomitant medications were reported. On 04-DEC-2014, while patient was still in the office, he experienced mild redness at the injection site. There was no lab diagnostics studies performed. Treatment was given with diphenhydramine hydrochloride. The outcome of adverse event was not provided. Additional information has been requested.
I had Covid in January 2021.   When I had covid, it was a milder case, primarily head and sinus related.  The cough and tightness of chest were later symptoms.  I did end up on a antibiotic b/c I had a secondary infection by day 14 which cleared up with the antibiotic.   When I received the vacination, I had that same chest tightness that I experienced.  It did lighten up within a few hours but the next 24 hrs included a mild fever with really bad body pain, joints, muscle cramps and fatigue.  Next day, I was fine.
onset on 20MAY98 of parotid gland swelling & irritability;amylase elevated significantly when checked on 22MAY98;clinically this pt appeared to have mumps;
Developed severe left upper quadrant pain for 45 minutes ; was in agony; it then resolved
PT. c/o lightheaded/dizzy. Pt. brought to private Treatment area. Pt. history and vitals obtained. Pt. monitored for 30 mins. Pt. stated she was feeling better and was ready to go home. Pt. released and advised to call 911 w/any further problems.
Immediate redness and swelling of the in site. Pt felt slight itching and hives. ZANTAC 300 mg 1 dose, 40 mg prednisone 1 dose, ZYRTEC 10 mg 1 dose.
Case number PHEH2014US020662 is an initial spontaneous report from the nurse received on 10 Oct 2014. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1410801) intramuscularly on 10 Oct 2014. On the same date, 30 minutes after vaccination her had started swelling. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
3-21-21 at 5:35am - Intermittent coughing during HS. Afebrile. Upper lung fields noted congestion; clearing when coughing/turned repositioned per staff, Afebrile.  3-21-21 at 9:30am -  In residents room repositioning him, resident vomited tube feeding. Turned him on his side and swept out his mouth. Tube feeding pump turned off. Breathing became labored. Second nurse placed non-rebreather mask on him. Called 911 to take resident to hospital.   3-21-21 9:45am  EMS now at bedside. Pulse palpable, Cheyne Stokes respirations. O2 on per non-rebreather mask. EMS assessed resident- now in VT/VF CPR initiated. Code cart placed outside of door.  3-21-21 10:00am  Resident transferred out to Rig with an organized heart rhythm. Dr. ( on call for Dr.) notified of event and transport to hospital.
I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (not ongoing); "Covid", start date: 2020 (not ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), FEELING ABNORMAL (non-serious), HANGOVER (non-serious) all with onset 04Aug2021, outcome "not recovered" and all described as "I have not been right, feel like hangover and it has not gone away; I feel bad and completely horrible".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Extreme Tiredness, Extreme Body Aches (couldn't sit or stand w/out help), Extreme Sore Joints, Massive Headache, Nausea, Fever (both high & low), Dizzines, Extremely Weak, Pale & Wheezing (at times very difficult to breathe). All of the symptoms I listed started exactly 24 hours from the time I was given the TDAP vac. My husband called my doc when symptoms were still bad the next day (7/1/10), doc advised him to take me to the local emergency room. Hospital doc said my symptoms did not match with what that shot list for TDAP stated & said I had a bladder infection (I just gave birth 4 days prior). My joints in my knees still hurt since getting that vac & soreness & tiredness is still an ongoing problem.
Failure of injection equipment - patient injected with likely less than half a dose of Moderna vaccine due to needle coming off of syringe during injection.  Given additional dose the following day after review of clinical considerations on CDC website. and recommendation to give additional dose in opposite arm if dose was less than half of recommended dose.
Left knee effusion on 10/5/17 that continued to worsen with swelling, pt was seen in clinic again 10/6/17 at which time, knee aspiration was performed. Synovial fluid aspiration showed 75% eosinophils.
This spontaneous report was received from a patient's wife referring to her 66-year-old husband. The patient's pertinent medical history was not reported. On 17-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 intramuscular administration in the unspecified arm (dose, lot# and expiration date were not reported). The patient's concomitant medications were not reported. On 18-NOV-2015, the patient complained on his arm hurting at the injection site and chills. The patient stated that his arm was swollen and red, from his shoulder down to his elbow. On 18-NOV-2015, the patient saw his (unspecified) neurosurgeon and advised of his symptoms. The neurosurgeon recommended to the patient visit at his primary physician. On the same day, the patient went to his primary physician, who recommended prednisone (manufacturer unknown) as a treatment. The patient's symptoms began improving the next day, after the first dose of prednisone (manufacturer unknown). The outcome of pain at the injection site, chills, swollen and red arm was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as no contact details were included.
shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, about a week after the first dose, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a patient receiving an expired ACT-HIB with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who was receiving an expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 11-Apr-2023, the patient received dose 4 at 0.5ml total of suspect HIB (PRP/T) VACCINE (Strength: standard) (lot number: UJ650AAB, expiry date: 10-Apr-2023) via intramuscular route in the left thigh for Immunization and on the same day patient receiving an expired act-hib with no reported adverse event (expired product administered).  It was reported, caller asked for information on how to proceed in this situation?   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; Vaccine administered to patient past its 30 day expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022 at 2:02 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's ethnicity was reported.  Patient received second booster dose of Moderna COVID-19 Vaccine on 01-Apr-2022.  No concomitant medication information was provided.  No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
COVID arm, onset about 8 days post vaccine, lasted about 3-4 days, went away on its own, no treatment.
Received Moderna vaccines on 3/17, 4/16/21 COVID-19 positive by PCR on  1/9/22 admitted to hospital (ICU) on 1/9/22 d/t Acute hypoxemic and hypercapnic respiratory failure in the setting of pneumonia and pulmonary edema (main contributor), requiring NIV support,  COVID-19 pneumonia
3 hrs. after - fainting, sweating, head ache, severe body aches.  Lasting for 2 days.
Redness and warmth on right deltoid, increased temp 102.3-rash at site, last night
Patient passed out; vomited 5 or so minutes later; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on 04Aug2021 (lot number and expiry date: unknown) at the age of 16-years-old, as dose 1, single, for COVID-19 immunization. The patient's medical history included fear of needles, has passed out 4 or so times in past from injections/needles and taking of blood at doctors' offices. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in doctor's office/urgent care. On 04Aug2021, the patient passed out and vomited 5 or so minutes later. The events were not treated. The patient recovered from the events on unspecified date in 2021. The patient has not been tested for COVID-19 since vaccination.  Information on lot/batch number has been requested.
Achy body, temp 99.3 on 7/29/20 and 100.1 on 7/30/20, Swollen arm at injection site.
Patient received the vaccine at 9p.m. 7/10/2017. The next evening, 7/11/2017, patient complained of tenderness and erythema at the injection site. Dr. and ICP nurse notified that evening and BENEDRYL was ordered. Patient was seen by PA on 7/12/17 a.m. and a MEDROL dosepak was ordered. ICP Nurse assessed patient and measured an induration of 25 cm x 15 on left arm. Area was red and warm to touch. Vitals were WNL; Temp: 99.2. Nurse contacted physician who ordered Doxycycline 100 mg PO BID x 7 days. On 7/13/2017, patient was seen by PA and ICP Nurse; minimal induration present, redness subsided. Patient reports lingering headache and tenderness. Vitals WNL.
This spontaneous report as received from a registered nurse via pharmacist and refers to a patient of unknown gender between 12 and 15 month. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On an unknown date, the patient was vaccinated with two doses of M-M-R II (dose, route of administration, lot# and expiration date were not reported) on one day. The M-M-R II was reconstituted with sterile diluent. No adverse effects were reported.
No additional AE details; The excursion occurred on May 12th and vaccine have been administered to an uknown amount of patients since then; This spontaneous report was received from a consumer referring to unspecified number of patients of unknown age and gender. The patients medical history, concomitant therapies and concurrent conditions were not reported.  On 12-MAY-2022, the following varicella virus vaccine live (oka/merck) (VARIVAX) vaccine's lot numbers: T020651 with expiration date 16-JUN-2022, T041687 with expiration date 10-DEC-2022, U022321 with expiration date 15-JUL-2023, U025789 with expiration date 19-AUG-2023 , U029621 with expiration date 22-SEP-2022, and U002398 with expiration date 22-JAN-2023,; sterile diluent (DILUENT MRK) (lot# and expiration date were not provided); and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) vaccine's lot number W006596 with expiration date 23-AUG-2023,  underwent a temperature excursion of -10 degree Celsius (°C) up to 8°C (average temperature -7.9°C) for 6 hours and 25 minutes (Product storage error). There was no previous temperature excursion..  On unspecified date in May 2022 (reported as "since the temperature excursion"),an unknown amount of patients were vaccinated with the reported lot number of  varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, route of administration and anatomical location were not provided), (strength, dose, route of administration and anatomical location were not provided); ; sterile diluent (DILUENT MRK); and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccine ( lot number W006596 with expiration date 23-AUG-2023) (dosage regimen, route of administration and anatomical location were not provided). Both suspect vaccines were administered for prophylaxis.  No adverse events (AE) were reported, and no further information was provided.  It was unknown if all lot numbers had been administered or how many from each lot number.  This is a non-valid report due to referred to an unspecified number of patients and no patient's identifier provided
Information has been received from a registered nurse concerning her daughter, a 3 year old female who in approximately 2006 (2 years ago) was vaccinated with the first dose of VARIVAX (Oka/Merck). Within one week of receiving the vaccination, the patient experienced 100 lesions of chicken pox on her trunk, arms and face. Subsequently, the patient recovered from chicken pox. Unspecified medical attention was sought. Additional information has been requested.
bleeding at injection site; injection site red; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at injection site), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at injection site), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at injection site) had resolved and VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: NNI: consumer declines further FU; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt. suffered from a febrile seizure 1 day post vaccines (DTAP, HIB, Flu vaccine). Pt. was transported by EMS to ER where pt. was admitted and evaluated.