chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.; Patient received vaccines past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) in a 28-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 05-Mar-2022 at 9:17 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Mar-2022 at 9:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient allergies to medications, food and other products was unknown. Vaccination date was reported as 05 Mar 2022 09:17:53.The patient received booster dose. Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Information has been received from a health professional concerning a patient who was vaccinated with a first and second dose of Rotateq (Lot# 655407/1115F and 656194/0024U) on 11-JAN-2007 and 04-MAY-2007, respectively. It was reported that the patient was not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This spontaneous report as received from a pharmacist via other company Pfizer and refers to an approximately 65 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, frequency, dose, route, batch/lot number and expiry date not reported) for prophylaxis. On an unknown date the patient experienced swollen arm  and injection site pain. The reporter considered peripheral the events to be related to PNEUMOVAX 23. The outcome of the events were unknown. This is one of 3 reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002598.
Shot did not stop mine/ Suspected vaccination failure; Shot did not stop mine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and it did not stop the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ lot# N010706, expiration date 02-DEC-2018 (exact dose, frequency and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (also reported as 54 degrees Fahrenheit) for 19 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported.
Burning sensation in arm and anxiety/panic immediately following injection. Next day experienced headache, muscle aches in arm, neck, back, bruising of R leg, fatigue/exhaustion for 2-3 days.
Received immunization 10/25/02. On 10/27/02 temperature of 102.5. Mother gave Tylenol. Down 1 degree within 1/2 hour. Temperature continued to come down. Today fussy/no fever.
No additional AE; Two doses of MMR II administered after a prior temperature excursion; route: IM; Information has been received from a nurse, referring to a 12 month old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.    On 15-JUN-2022, the patient was vaccinated with the first dose of temperature excursion measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T039671 (therapy type rHA), expiration date on 24-NOV-2022) intramuscularly for prophylaxis (incorrect route of product administration and product storage error). No adverse effects were reported.   The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was entered with freezer temperature/time instead of the refrigerated temperature/time on 12-APR-2022. The vaccines had a temperature prior of 10.4 Celsius degree for 3 hours and 30 minutes; current of 8.6 Celsius degree of 1 hour 1 minute.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA006637:
diluent portion of ActHib that was used for the dose had expired/no AE; Initial information received on 16-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves a 20 months old female patient who received expired diluent containing vaccine HIB (PRP/T) VACCINE [ACT-HIB] which was later realized. (PT: Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and HEPATITIS A VACCINE (HEPATITIS A).  On 15-Apr-2020, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE via unknown route in the left thigh for prophylactic vaccination. Powder portion lot, UI990AA expiry 30-Oct-2020 and Diluent portion was U6193AA expiry 01-Apr-2020. The caller stated the carton had the same lot and expiry as the diluent portion.  It was of actual medication error due to Expired product used. The caller stated that it did not seem right to her that the product would be packaged with different expiration dates for different portions. She stated that the product should not be packaged such that the diluent portion expires earlier than the HIB powder portion, as was the case in this instance.  It was unknown whether adverse event was experienced or not.  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 and Module VI of the 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.
Patient developed increasing  erythema, warmth, pruritus and tenderness on left upper arm starting  2/13/2021.
rapid heart rate and intermittent palpitations onset ~30 min after shot and lasting ~3 hours, diarrhea
Information has been received from a physician's assistant concerning a patient who in approximately January 2008, "7 months ago", was vaccinated with the first dose of GARDASIL vaccine (yeast). On the same day, "shortly after the first dose was given", the patient developed a "knot" at the injection site. The patient had since been given the next 2 doses and had not reported any adverse reactions. On an unspecified date the patient recovered from a "knot" at the injection site. The patient contacted the physician's office and sought unspecified medical attention. Additional information has been requested.
Client presented to the vaccination site on 12/15/21. The client reported she received a first dose of Moderna COVID vaccine on 3/30/21 and a second dose of Moderna COVID vaccine on 4/27/21. Client stated 2 hours after 2nd dose she developed nausea that lasted 2-3 hours. Client denied any dizziness, shortness of breath or symptoms of anaphylaxis. Client ate saltines to help with nausea. Client denied any emesis. Client didn't follow up with PCP. Client has no chronic conditions. Client reported taking oxybutynin for her bladder. Client reported a history of a rash with latex. RN submitted a medical consult via text message to clinical project coordinators requesting to proceed with the Pfizer COVID vaccine. Per Dr. approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via text message from, clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841, on 12/15/21 by, RN. The client did not report any symptoms during the 30-minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1755 wheelchair assisted.
After adminsitering 0.2ml dose it was noticed that the pediatric pfizer bottle had not been reconstituted..  there was not adverse reaction after monitoring patient in the store for 30 minutes.  Adminstering pharmacist called Pfizer to identify any monitoring parameters and informed patient/mother accordingly.
Not given here in our office - Mom called us - We are the PCP. Mother called and wants to have report filed with adverse reaction committee due to his reaction from vaccine. Mother reports that baby has been vomiting multiple times between feeds (at least 10 times), severe diarrhea and no sleep at all for 7 days. Mother reports that baby decreased in diapers during those 7 days of being ill. Mother reports that child is not a crying baby and he has been severely crying since vaccines on October 23rd. Pt has been seen at medical facility on Friday October 31st and the after hours medical facility on October 25th. Mother reports that both physicians who seen the child claim that the illness came from the vaccines. Mother reports that these vaccines came from the health department and were active for the HIB and ROTATEQ for the rotavirus. She will contact the health department to report pt adverse reaction. Mother said that pt has been better since rehydration regimen that was advised from physicians seen over the week. In addition, mother reports that child has been diagnosed with mylingual malasia and has been affected greatly from all the throwing up.
I woke up on a Friday morning, went to put my contacts in and had a stroke. I couldnt speak or do anything with my hands like operate a phone. My husband called emergency phone number and they took me to the Hospital where they preformed an MRI. Results were an acute ischemic left middle cerebral artery stroke. I was flown to a Medical Center and received a mechanical thrombectomy.   I am an otherwise very healthy person. I am 5'5" and weigh 124 lbs. I eat healthy and exercise 5 times a week. The clot was over 3 cm and very new. It took the surgeon 6 entries to remove the new clot.
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no medical history and no drug allergy. It was reported that the patient was not pregnant. On 12-SEP-2014 the patient was vaccinated with ZOSTAVAX (reported as vial 19400PFU, lot # K000726, expiry date: 09-JAN-2015, dose: 0.65 ml, route of administration: subcutaneous, arm). There was no concomitant medication. In approximately September 2014, after receiving the injection the patient experienced very swollen arm/injection site was very swollen. The patient was seen by a physician and was treated with penicillin. No lab diagnostic was performed. The outcome of very swollen arms after receiving the injection/injection site was very swollen was unknown. The relatedness between ZOSTAVAX and very swollen arms after receiving the injection/injection site was very swollen was not reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker referring to a patients of unknown age and gender. Since 02-NOV-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency and route of administration were not reported, lot# L013824 expiration date: 21-APR-2017; lot# reported as L029472 expiration date: 06-AUG-2017), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
- Provisional diagnosis of Polyarthritis. Symptoms consistent with Rheumatoid Arthritis, however, labs appear normal. - Symptoms consist of pain and swelling in the joints of the hands, wrists, and feet. Symmetrical. Worse in the mornings and after use. - Onset occurred over two days at the end of July2021 and are still present. - Treatment includes Voltaren Gel (effective), and NSAIDs (partially effective)
Significant COVID symptoms short of hospitalization including aches severe headaches congestion lingering cough fatigue diarrhea
After administration of HPV, patient became dizzy and proceeded to faint. Pt was in this state for about 20 seconds. After laying down for 20 minutes and several cups of water patient was able to sit up. After sitting for about 5 minutes, patient was able to stand and walk around exam room without dizziness. Patient was with complete resolution of symptoms upon leaving clinic.
Treatment of COVID-19; 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 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Feb2021 at 09:30 as dose 1, single (Lot number: EM9810), in left arm, on 03Mar2021 at 12:45 as dose 2, single (Lot number: EN6199), in left arm, on 23Nov2021 at 09:30 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 27Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrosis" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis; "HTN" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis; "Dyslipidemia" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: Jun2017; SIMVASTATIN, start date: Jun1997, stop date: 03Sep2023; LISINOPRIL, start date: 28Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 03Sep2023 to 08Sep2023
Little soreness on the area of the injection; Warm to touch; Area of the injection got sore again/pain; Note of redness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain), VACCINATION SITE ERYTHEMA (Note of redness) and VACCINATION SITE PAIN (Little soreness on the area of the injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE PAIN (Little soreness on the area of the injection). In November 2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain) and VACCINATION SITE ERYTHEMA (Note of redness). On 15-Nov-2021, VACCINATION SITE PAIN (Little soreness on the area of the injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (Area of the injection got sore again/pain) and VACCINATION SITE ERYTHEMA (Note of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that soreness went away on 4th day and reappeared on 8th -9th day. Patient started experiencing by 8th-9th day there was note of redness and warm to touch and pain on the area of the injection.
expired MMR II was administered. Patient does not report sigs/symptoms of adverse effects.; expired MMR II was administered. Patient does not report sigs/symptoms of adverse effects.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023 the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous injection, expiration date: 14-JUN-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided). Patient did not report signs/symptoms of adverse effects.
1940: pt reported tingling and coldness in right fingers, no respiratory distress, no signs of allergic reaction, pt requested to go home and stated she was fine
She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm left, administration date 10Sep2021 17:00 (Lot number: FF2588) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "A.D.D." (unspecified if ongoing); "Sprained ankle" (unspecified if ongoing). Prior to vaccination, the patient did not diagnose with COVID-19. She was absolutely healthy before. no surgeries, no medical issues other than a sprained ankle. Concomitant medication(s) included: ADDERALL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 20Aug2021, when the patient was 15 years old, for COVID-19 immunization. She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time. She can no longer do sports and this is destroying her. The following information was reported: PARALYSIS (disability) with onset 17Nov2021 17:30, outcome "not recovered", described as "She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time". The event "she is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. they said it can last days, weeks or even months at a time" was evaluated at the physician office visit and emergency room visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of paralysis. Potassium to see if raising her potassium helps.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-418964 (Patient Link).